A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia

Start 13 Jul 2020 · Status Ongoing, recruiting · 14 EU/EEA countries · 103 sites · Protocol ALLTogether1

Overview

Sponsor-declared trial summary

Phase Phase II and Phase III (Integrated)

Status Ongoing, recruiting

Participants planned 8,503

Countries 14

Sites 103

Acute Lymphoblastic Leukaemia

Key facts

Sponsor: Karolinska University Hospital
Participant type: Pediatric, Patients
Age range: 0-17 years, 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 13 Jul 2020 → ongoing
Decision date (initial): 2024-10-16
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes
Funding sources: The Swedish Cancer Society · Danish Cancer Society · Servier · The Swedish Childhood Cancer Foundation · Nova Laboratories Ltd. · Novo Nordic Foundation · Amgen · Danish Childhood Cancer Foundation · NordForsk · Pfizer · Swedish Research Council

External identifiers

EU CT number: 2022-501050-11-01
EudraCT number: 2018-001795-38
ClinicalTrials.gov: NCT04307576

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacoeconomic, Dose response, Therapy, Efficacy, Pharmacodynamic, Safety, Pharmacokinetic

The primary objective of ALLTogether is to improve survival and quality of survival in infants, children and young adults with acute lymphoblastic leukaemia by a number of interventions that will be tested in a randomised fashion, compared with well-defined control-populations within the Protocol or explored in a non-randomised fashion either to obtain baseline information regarding characteristics, leukaemia-specific outcomes and toxicity or to be compared with well defined historical controls. A sub-group of patients will be identified that may benefit from novel immunotherapy.

Secondary objectives 5

To investigate if SR- and IR-low patients can benefit from de-intensification of therapy. Overall survival (OS) and leukaemia outcomes are balanced against toxicity including relapse treatment. Quality of life (QoL) measurements will ascertain and compare the burden of therapy.
To ascertain if addition of Inotuzumab (InO) or low-dose 6-thioguanine (TEAM) impacts OS or other adverse outcomes and to assess if the toxicity induced by InO/TEAM is significant and acceptable. QoL measurements will assess the burden of the experimental intensifications.
For patients treated with TKI, baseline data regarding OS, adverse outcomes, toxicity and QoL will be collected for future reference.
To ascertain if replacing conventional chemotherapy with blinatumomab can improve leukaemic outcomes and reduce toxicity in Down patients.
For patients defined as eligible for CAR-T survival, specific leukaemic adverse events, toxicity and QoL resulting from conventional HR-therapy and CAR-T cell treatment is measured.

Conditions and MedDRA coding

Acute Lymphoblastic Leukaemia

Version	Level	Code	Term	System organ class
21.0	LLT	10000844	Acute lymphoblastic leukaemia	10029104

Regulatory references

Scientific advice from competent authorities: Swedish Medical Products Agency
EMA paediatric investigation plan (PIP): EMEA-001429-PIP01-13
Plan to share IPD: Yes

EU CT number	Title	Sponsor
2022-501050-11-00	ALLTogether1 - A Treatment Study Protocol of the ALLTogether Consortium for Children and Young Adults (0-45 Years of Age) with Newly Diagnosed Acute Lymphoblastic Leukaemia (ALL)	Karolinska University Hospital

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

Patients newly diagnosed with T-lymphoblastic (T-cell) or B-lymphoblastic precursor (BCP) leukaemia (ALL) according to the WHO-classification of Tumours of Haematopetic and Lymphoid Tissues (Revised 4th edition 2017) and with a diagnosis confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.
Age ≥ 0 days and < 46 years (one day before 46th birthday) at the time of diagnosis.
Patients with surface IG negative BCP-ALL and an IG::MYC rearrangement unless they have a concurrent BCL2/6 rearrangement. T-ALL patients with MYC translocations.
Informed consent signed by the patient and/or parents/legal guardians according to country-specific age-related guidelines (http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/12/WC500199234.pdf ).
The ALL diagnosis should be confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.
The patient should be diagnosed and treated at a participating paediatric oncology or adult haematology centre in the participating countries.
The patient should be a resident in one of the participating countries on a permanent basis or should intend to settle in a participating country, for instance by an application for asylum. Patients who are visiting the country as tourists should not be included. However, returning expatriots with primary diagnosis abroad may be included if no treatment has been administered and the diagnostic procedures are repeated at a participating centre.
All women of childbearing potential (WOCBP) have to have a negative pregnancy test within 2 weeks prior to the start of treatment.
For each intervention/randomisation an additional set of inclusion-criteria is provided.

Exclusion criteria 15

Age < 365 days at diagnosis and KMT2A-r BCP-ALL (documented presence of a KMT2A-split by FISH and/or a KMT2A transcript). These patients will be transferred to an appropriate trial for KMT2A-r BCP infant ALL if available.
Age >45 years at diagnosis (from the 46th birthday onwards)
Patients with a previous malignant diagnosis (ALL as a second malignant neoplasm - SMN).
Relapse of ALL.
Patients with mature B-ALL (as defined by surface IG positivity) or any patients with IG::MYC and a concurrent BCL2/6 rearrangement.
Patients with Ph-positive ALL (documented presence of t(9;22)(q34;q11) and/or of the BCR::ABL1 fusion transcript). These patients will be transferred to an adequate trial for t(9;22) if available.
Previously known ALL prone syndromes (e.g. Li-Fraumeni syndrome, germline ETV6 mutation), except for Down syndrome. Exploration for such ALL prone syndromes is not mandatory and patients in whom genetic work-up reveals a new germ-line mutation (index-cases) will remain in the study.
Treatment with systemic corticosteroids (corresponding to >10mg prednisolone/m2/day) for more than one week and/or other chemotherapeutic agents in a 4-week interval prior to diagnosis (pre-treatment).
Pre-existing contraindications to any treatment according to the ALLTogether protocol (constitutional or acquired disease prior to the diagnosis of ALL preventing adequate treatment).
Any other disease or condition, as determined by the investigator, which could interfere with the participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.
Women of childbearing potential who are pregnant at the time of diagnosis.
Women of childbearing potential and fertile men who are sexually active and are unwilling to use adequate contraception during therapy. Efficient birth control is required, see section 18.9.
Female patients, who are breast-feeding.
Essential data missing from the registration of characteristics at diagnosis (in consultation with the protocol chair).
For each intervention/randomisation an additional set of exclusion-criteria is provided.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

The primary endpoint for the whole protocol (compared with the legacy protocols of the participating study-groups forming the consortium) is event-free survival (EFS) - as defined in the protocol.
The primary endpoint for the randomised interventions is disease-free survival (DFS) - as defined in the protocol.
The primary endpoint for the replacement of conventional chemotherapy for patients with Down syndrome and detectable MRD at the end of induction (ALLTogether1 DS) is the fraction of patients with undetectable MRD after one cycle of blinatumomab. This fraction will be compared with a well defined historic control cohort from the UKALL2011 protocol.

Secondary endpoints 19

Main study - The most important secondary outcome is overall survival (OS).
Main study - Additional secondary measures of antileukaemic efficacy are: rate of -death during induction, -resistant disease, cumulative incidence of: -relapse (ciR), -death in first complete remission (ciDCR1) and -second malignancy (ciSMN).
Main study - Over- and under-treatment will also be combined into resulting treatment-related mortality (TRM) and leukaemia specific mortality (LSM) rates.
Main study - Since over-treatment also includes cured patients who suffer potentially permanent side-effects, data will be collected regarding the incidence of some adverse events of special interest. De-escalation of therapy may also result in relapses that have to be rescued with allogeneic stem-cell transplant (allo-SCT), which is associated with serious permanent side effects. Therefore, the incidence of allo-HSCT in CR1 and CR2 will also be measured.
Main study - An important aspect of evaluation of the quality of survival is measurement of quality of life (QoL). The whole protocol, as well as each of the non-randomised and randomised interventions will also be evaluated by measurements of quality of life (QoL). QoL will be measured by EQ5D-based instruments before and after all the randomised phases in all randomisations as well as later in the therapy and after cessation of treatment.
R1 and R2 - Efficacy: - Overall survival (OS), - Cumulative incidence of relapse (ciR), - Cumulative incidence of Death in CR1 (ciDCR1), - Cumulative incidence of SMN (ciSMN), - Fraction of surviving patients treated with allogenic stem-cell transplant in second remission, - Cumulative incidence of HSCT in CR2
R1 and R2 - Toxicity: The studies are powered to answer the primary end-point non-inferiority question with a certain safety-margin. Even if reduction of exposure to potentially toxic therapy is an objective in itself, it is also reasonable to show some immediately measurable benefit from the reduction of therapy if the study is successful and non-inferiority can be shown.
Non-lethal toxicities for the DI-phase (R1 and R2): - Rate of febrile neutropenia (yes/no) and agent (if isolated from a sterile site/blood), -Rate of invasive fungal infection (yes/no) together with assessment if "possible"/"probable"/"proven" and agent (if isolated from sterile site/blood/BAL), -Rate of serious viral reactivation (EBV, VZV, HSV, CMV), mucositis with need for intravenous analgesic and/or nutritional support with parenteral nutrition, - The incidence of SAEs (except AESI)
Non-lethal toxicities for the DI-phase (R1 and R2): -The time-interval between the start of DI and the start of the next treatment- phase in days, - Rate of cardiac failure or serious arrhytmia (CTCAE ≥ grade 3).
Quantifiable measures of the toxicities listed above (measured at the same time-points): -Days admitted to hospital during the randomised phase and until the start of the next treatment phase, -days on iv antibiotics, - days on advanced antifungals, -days on iv analgesics and/or nutritional support with parenteral nutrition.
Non-lethal toxicity for the Maintenance-phase (R2) Measured at the beginning of Maintenance and every 4 months during the maintenance-phase: -Rate of VCR-neuropathy Grade ≥3 according to the PdL definition, -The number of doses of VCR that had to be reduced or omitted, -Cumulative incidence of symptomatic osteonecrosis + grade.
Follow-up end-point of obesity: Body-mass index at the time of cessation of therapy and 5 years after the end of therapy.
R3-InO and R3-TEAM secondary endpoints - Efficacy: -Overall survival (OS), - Cumulative incidence of relapse (ciR), -Occurence of CD22 negative relapse (InO), -Relation of all adverse outcomes with DNA-TG (TEAM).
R3-InO and R3-TEAM - Toxicity: -Incidence and severity of SOS/VOD all grades, - Incidence and severity of other liver toxicity (defined as AST/ALT elevations grade > 3 and bilirubin grade >3)
Toxicity InO: -Incidence and severity of infections CTCAE grade > 3, -Incidence and duration of B-cell depletion reflected by immunoglobulin levels/IV immunoglobulin supplementation
Toxicity TEAM: -Cumulative incidence of SMN (ciSMN; TEAM), -Cumulative Incidence of NRH, -Cumulative Incidence of osteonecrosis, -Cumulative Incidence of hypoglycaemia
Exploratory endpoint (InO): CD22 expression level of leukemic cells in bone marrow samples at diagnosis and at TP2 (day 71).
ALLTogether1 DS secondary endpoints: -Event-Free Survival (EFS), -Overall Survival (OS), -Cumulative incidence of relapse (ciR) and CD19 negative relapse, -Cumulative incidence of Death in CR1 (ciDCR1), -Cumulative incidence of SMN (ciSMN), -Cumulative incidence of blinatumomab refractory disease, -Cumulative incidence of Protocol Therapy Failure
Exploratory endpoint ALLTogether1 DS: MRD response at any timepoint within 2 cycles of blinatumomab

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 18

Dexamethasone

SUB07017MIG · Substance

Active substance: Dexamethasone
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 6 mg/m2 milligram(s)/sq. meter
Max total dose: 540 mg/m2 milligram(s)/sq. meter
Max treatment duration: 90 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Hydrocortisone Sodium Succinate

SUB02569MIG · Substance

Active substance: Hydrocortisone Sodium Succinate
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION OR INFUSION
Route of administration: INTRATHECAL USE
Max daily dose: 24 mg milligram(s)
Max total dose: 144 mg milligram(s)
Max treatment duration: 6 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methylprednisolone Sodium Succinate

SUB14562MIG · Substance

Active substance: Methylprednisolone Sodium Succinate
Pharmaceutical form: POWDER FOR INJECTION
Route of administration: INTRATHECAL USE
Max daily dose: 4.8 mg milligram(s)
Max total dose: 28.8 mg milligram(s)
Max treatment duration: 6 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRATHECAL USE
Max daily dose: 12 mg milligram(s)
Max total dose: 72 mg milligram(s)
Max treatment duration: 6 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRATHECAL USE
Max daily dose: 12 mg milligram(s)
Max total dose: 48 mg milligram(s)
Max treatment duration: 4 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Mercaptopurine

SUB12149MIG · Substance

Active substance: Mercaptopurine
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 75 mg/m2 milligram(s)/sq. meter
Max total dose: 37275 mg/m2 milligram(s)/sq. meter
Max treatment duration: 71 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Mercaptopurine

SUB12149MIG · Substance

Active substance: Mercaptopurine
Pharmaceutical form: ORAL SUSPENSION
Route of administration: ORAL USE
Max daily dose: 75 mg/m2 milligram(s)/sq. meter
Max total dose: 37275 mg/m2 milligram(s)/sq. meter
Max treatment duration: 71 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Vincristine Sulfate

SUB05101MIG · Substance

Active substance: Vincristine Sulfate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS USE
Max daily dose: 1.5 mg/m2 milligram(s)/sq. meter
Max total dose: 27 mg/m2 milligram(s)/sq. meter
Max treatment duration: 18 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion

PRD3418637 · Product

Active substance: Blinatumomab
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 28 µg microgram(s)
Max total dose: 1568 µg microgram(s)
Max treatment duration: 8 Week(s)
Authorisation status: Authorised
ATC code: L01XC19 — -
Marketing authorisation: EU/1/15/1047/001
MA holder: AMGEN EUROPE B.V.
MA country: EU
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/09/650
Modified vs. Marketing Authorisation: No

Cytarabine

SUB06880MIG · Substance

Active substance: Cytarabine
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRATHECAL USE
Max daily dose: 30 mg milligram(s)
Max total dose: 180 mg milligram(s)
Max treatment duration: 6 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

BESPONSA 1 mg powder for concentrate for solution for infusion

PRD6504828 · Product

Active substance: Inotuzumab Ozogamicin
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS USE
Max daily dose: 0.5 mg/m2 milligram(s)/sq. meter
Max total dose: 3 mg/m2 milligram(s)/sq. meter
Max treatment duration: 6 Day(s)
Authorisation status: Authorised
ATC code: L01XC26 — -
Marketing authorisation: EU/1/17/1200/001
MA holder: PFIZER EUROPE MA EEIG
MA country: EU
Paediatric formulation: No
Orphan designation: Yes
Orphan designation number: EU/3/13/1127
Modified vs. Marketing Authorisation: No

Hydrocortisone Sodium Phosphate

SUB02568MIG · Substance

Active substance: Hydrocortisone Sodium Phosphate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRATHECAL USE
Max daily dose: 24 mg milligram(s)
Max total dose: 144 mg milligram(s)
Max treatment duration: 6 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Prednisolone Sodium Succinate

SUB04019MIG · Substance

Active substance: Prednisolone Sodium Succinate
Pharmaceutical form: POWDER FOR SOLUTION FOR INJECTION
Route of administration: INTRATHECAL USE
Max daily dose: 6 mg milligram(s)
Max total dose: 36 mg milligram(s)
Max treatment duration: 6 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Mercaptopurine

SUB12149MIG · Substance

Active substance: Mercaptopurine
Pharmaceutical form: ORAL SUSPENSION
Route of administration: ORAL USE
Max daily dose: 50 mg/m2 milligram(s)/square meter
Max total dose: 24580 mg/m2 milligram(s)/sq. meter
Max treatment duration: 71 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Mercaptopurine

SUB12149MIG · Substance

Active substance: Mercaptopurine
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 50 mg/m2 milligram(s)/sq. meter
Max total dose: 24850 mg/m2 milligram(s)/sq. meter
Max treatment duration: 71 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Tioguanine

PRD9881810 · Product

Active substance: Tioguanine
Pharmaceutical form: ORAL SUSPENSION
Route of administration: ORAL USE
Max daily dose: 12.5 mg/m2 milligram(s)/sq. meter
Max total dose: 6212.5 mg/m2 milligram(s)/sq. meter
Max treatment duration: 71 Week(s)
Authorisation status: Not Authorised
MA holder: KAROLINSKA
Paediatric formulation: Yes
Orphan designation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: TABLETS
Route of administration: ORAL USE
Max daily dose: 20 mg/m2 milligram(s)/sq. meter
Max total dose: 9940 mg/m2 milligram(s)/sq. meter
Max treatment duration: 71 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Imatinib

SUB25387 · Substance

Active substance: Imatinib
Pharmaceutical form: FILM-COATED TABLET
Route of administration: ORAL USE
Max daily dose: 340 mg/m2 milligram(s)/sq. meter
Max total dose: 252280 mg/m2 milligram(s)/sq. meter
Max treatment duration: 106 Week(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Comparator 3

Doxorubicin

SUB06391MIG · Substance

Active substance: Doxorubicin
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS USE
Max daily dose: 30 mg/m2 milligram(s)/sq. meter
Max total dose: 90 mg/m2 milligram(s)/sq. meter
Max treatment duration: 3 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dexamethasone

SUB07017MIG · Substance

Active substance: Dexamethasone
Pharmaceutical form: TABLET
Route of administration: ORAL USE
Max daily dose: 6 mg/m2 milligram(s)/sq. meter
Max total dose: 570 mg/m2 milligram(s)/sq. meter
Max treatment duration: 95 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Vincristine Sulfate

SUB05101MIG · Substance

Active substance: Vincristine Sulfate
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS USE
Max daily dose: 1.5 mg/m2 milligram(s)/sq. meter
Max total dose: 28.5 mg/m2 milligram(s)/sq. meter
Max treatment duration: 19 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Karolinska University Hospital

Sponsor organisation: Karolinska University Hospital
Address: Eugeniavagen 3
City: Solna
Postcode: 171 64
Country: Sweden

Scientific contact point

Organisation: Karolinska University Hospital
Contact name: Trial Central Office

Public contact point

Organisation: Karolinska University Hospital
Contact name: Trial Central Office

Third parties 11

Organisation	City, country	Duties
Oslo University Hospital HF ORG-100021349	Oslo, Norway	Laboratory analysis
University Of Glasgow ORG-100008435	Glasgow, United Kingdom	Laboratory analysis
GPOH gGmbH ORG-100027559	Essen, Germany	Code 12
Rigshospitalet ORG-100002431	Copenhagen Oe, Denmark	Laboratory analysis
Paediatrisches Forschungsnetzwerk gGmbH ORG-100048280	Essen, Germany	On site monitoring, Code 12
Prinses Maxima Centrum voor Kinderoncologie B.V. ORG-100011005	Utrecht, Netherlands	Laboratory analysis
Karolinska University Hospital ORG-100000573	Solna, Sweden	Other
Frederiksberg Hospital ORG-100028217	Frederiksberg, Denmark	On site monitoring
Ciwit B.V. ORL-000000712	Amsterdam, Netherlands	E-data capture
University Medical Center Hamburg-Eppendorf ORG-100008810	Hamburg, Germany	Code 5, Data management
Zentrum fuer Forschungsfoerderung in der Paediatrie GmbH ORG-100048279	Essen, Germany	On site monitoring, Code 12

Locations

14 EU/EEA countries · 103 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Ongoing, recruiting	560	7
Denmark	Ongoing, recruiting	360	6
Estonia	Ongoing, recruiting	90	3
Finland	Ongoing, recruiting	360	10
France	Ongoing, recruiting	1,600	29
Germany	Ongoing, recruiting	540	6
Iceland	Ongoing, recruiting	25	1
Ireland	Ongoing, recruiting	245	4
Lithuania	Ongoing, recruiting	120	1
Netherlands	Ongoing, recruiting	825	2
Norway	Ongoing, recruiting	330	9
Portugal	Ongoing, recruiting	309	3
Spain	Authorised, recruitment pending	159	9
Sweden	Ongoing, recruiting	680	13
Rest of world United Kingdom	—	2,300	—

Investigational sites

Belgium

7 sites · Ongoing, recruiting

Universitair Ziekenhuis Gent

Pediatric hematology and oncology, Corneel Heymanslaan 10, 9000, Gent

Centre Hospitalier Regional De La Citadelle

Pediatric hematology and oncology, Boulevard Du Douzieme De Ligne 1, 4000, Liege

Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola

Pediatric hematology and oncology, Jean Joseph Crocqlaan 15, 1020, Brussels

Antwerp University Hospital

Pediatric hematology and oncology, Drie Eikenstraat 655, 2650, Edegem

UZ Leuven

Pediatric hematology and oncology, Herestraat 49, 3000, Leuven

CHC MontLegia

Pediatric hematology and oncology, Boulev. De Patience Et Beajonc 2, 4000, Liege

Cliniques Universitaires Saint-Luc

Pediatric hematology and oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe

Denmark

6 sites · Ongoing, recruiting

Rigshospitalet

Department of Hematology, Blegdamsvej 9, 2100, Copenhagen Oe

Region Midtjylland

Department of Haematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Odense University Hospital

Hans Christian Andersen Children's Hospital, J B Winsloews Vej 4, 5000, Odense C

Rigshospitalet

Department of paediatric and adolescent medicine, Blegdamsvej 9, 2100, Copenhagen Oe

Aalborg University Hospital

Department of paediatric and adolescent medicine, Reberbansgade 15, 9000, Aalborg

Aarhus Universitetshospital

Department of paediatric and adolescent medicine, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Estonia

3 sites · Ongoing, recruiting

North Estonia Medical Centre Foundation

Oncology and Haematology Clinic, J. Sutiste Tee 19, Mustamae Linnaosa, Tallinn

Tallinn Children's Hospital Foundation

Department of Haematology and Oncology, Tervise Tn 28, 13419, Mustamae Linnaosa

Tartu University Hospital

Haematology and Oncology Clinic, L. Puusepa Tn 1a, 50406, Tartu Linn

Finland

10 sites · Ongoing, recruiting

Pohjois-Pohjanmaan hyvinvointialue

Cancer Center, Department of Oncology and Hematology, Kajaanintie 50, 90220, Oulu

Pirkanmaan hyvinvointialue

Department of Hematology, Elamanaukio 2, 33520, Tampere

HUS-Yhtymae

New Children`s Hospital, Ward Taika, Stenbackinkatu 9, 00290, Helsinki

Varsinais-Suomen hyvinvointialue

Department of pediatric Hematology and Oncology, Kiinamyllynkatu 4-8, 20520, Turku

Pohjois-Savon hyvinvointialue

Department of pediatric Hematology and Oncology, Puijonlaaksontie 2, P. O. Box 1711, Kuopio

HUS-Yhtymae

Comprehensive Cancer Center, Department of Hematology, Haartmaninkatu 4, 00290, Helsinki

Varsinais-Suomen hyvinvointialue

Department on Hematology ward, Kiinamyllynkatu 4-8, 20520, Turku

Pohjois-Pohjanmaan hyvinvointialue

Department of pediatric Hematology and Oncology, Kajaanintie 50, 90220, Oulu

Pohjois-Savon hyvinvointialue

Department of Hematology, Puijonlaaksontie 2, P. O. Box 1711, Kuopio

Pirkanmaan hyvinvointialue

Children's Blood and Cancer Unit, Elamanaukio 2, 33520, Tampere

France

29 sites · Ongoing, recruiting

Les Hopitaux Universitaires De Strasbourg

Pediatric Hematology, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2

CHRU De Nancy

Pediatric Hematology, Rue Du Morvan, 54500, Vandoeuvre Les Nancy

University Hospital Of Clermont-Ferrand

Hématologie pédiatrique, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand

Centre Hospitalier Universitaire De Nantes

Pediatric Hematology, 7 Quai Moncousu, 44000, Nantes

Centre Hospitalier Universitaire De Poitiers

Pediatric Hematology, 2 Rue De La Miletrie, 86000, Poitiers

Centre Hospitalier Regional Et Universitaire De Brest

Hématologie pédiatrique, 2 Avenue Marechal Foch, 29200, Brest

Assistance Publique Hopitaux De Marseille

Pediatric Hematology, 264 Rue Saint Pierre, 13005, Marseille

Centre Hospitalier Universitaire De Dijon

Hématologie pédiatrique, 14 Rue Paul Gaffarel, 21000, Dijon

Assistance Publique Hopitaux De Paris

Pediatric Hematology, 1 Avenue Claude Vellefaux, 75010, Paris

Centre Hospitalier Universitaire De La Reunion

Pediatric Hematology, Allee Des Topazes, Cs 11021, Saint-Denis

Assistance Publique Hopitaux De Paris

Pediatric Hematology, 26 Avenue Du Docteur Arnold Netter, 75012, Paris

Centre Hospitalier Universitaire De Caen Normandie

Hématologie pédiatrique, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9

Centre Hospitalier Universitaire Grenoble Alpes

Hématologie pédiatrique, Quai Yermoloff, 38700, La Tronche

Centre Hospitalier Universitaire De Lille

Hématologie pédiatrique, Avenue Eugene Avinee, 59037, Lille Cedex

Centre Hospitalier Universitaire Reims

Pediatric Hematology, 45 Rue Cognacq Jay, 51092, Reims Cedex

Centre Hospitalier Universitaire De Montpellier

Pediatric Hematology, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5

Centre Hospitalier Universitaire De Bordeaux

Hématologie pédiatrique, Place Amelie Raba Leon, 33000, Bordeaux

Assistance Publique Hopitaux De Paris

Pediatric Hematology, 48 Boulevard Serurier, 75019, Paris

Centre Hospitalier Universitaire De Rennes

Pediatric Hematology, 16 Boulevard De Bulgarie, Bp 90349, Rennes

Hospices Civils De Lyon

Hématologie pédiatrique, 3 Quai Des Celestins, Bp 2251, Lyon Cedex 02

Centre Hospitalier Universitaire De Toulouse

Pediatric Hematology, 330 Avenue De Grande Bretagne, 31059, Toulouse Cedex 9

Centre Hospitalier Et Universitaire De Limoges

Hématologie pédiatrique, 2 Avenue Martin Luther King, 87000, Limoges

Centre Hospitalier Regional Universitaire De Tours

Pediatric Hematology, 49 Boulevard Beranger, 37000, Tours

Centre Hospitalier Universitaire De Nice

Pediatric Hematology, 151 Route De Saint Antoine, 06200, Nice

Besancon University Hospital Center

Hématologie pédiatrique, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex

Centre Hospitalier Universitaire De Saint Etienne

Pediatric Hematology, Avenue Albert Raimond, 42270, Saint Priest En Jarez

Centre Hospitalier Universitaire Amiens Picardie

Hématologie pédiatrique, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1

Centre Hospitalier Universitaire D'Angers

Hématologie pédiatrique, 4 Rue Larrey, 49100, Angers

CHU De Rouen

Pediatric Hematology, 1 Rue De Germont, Bp 96031, Rouen Cedex

Germany

6 sites · Ongoing, recruiting

HELIOS Klinikum Krefeld GmbH

Pädiatrische Hämatologie und Onkologie, Lutherplatz 40, Diessem/lehmheide, Krefeld

Gesundheit Nord gGmbH Klinikverbund Bremen

Kinderonkologisches Zentrum, St.-Juergen-Strasse 1, Hulsberg, Bremen

Universitaetsklinikum Bonn AöR

Zentrum für Kinderheilkunde Pädiatrische Onkologie / Hämatologie, Venusberg-Campus 1, Venusberg, Bonn

Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz

Zentrum für Kinder- und Jugendmedizin, Langenbeckstrasse 1, Oberstadt, Mainz

Evangelisches Klinikum Bethel gGmbH

Klinik für Kinder- und Jugendmedizin Hämatologie/Onkologie, Grenzweg 14, Gadderbaum, Bielefeld

University Medical Center Hamburg-Eppendorf

Zentrum f. Geburtshilfe-, Kinder- u. Jugendmedizin, Klinik u. Poliklinik f. Päd. Hämatologie, Martinistrasse 52, Eppendorf, Hamburg

Iceland

1 site · Ongoing, recruiting

Landspitali

Pediatric Hematology and Oncology, Hringbraut 101, 101, Reykjavik

Ireland

4 sites · Ongoing, recruiting

University Hospital Galway

Haematology Oncology, Newcastle Road, H91 YR71, Galway

St James's Hospital

Haematology Oncology, James's Street, D08 NHY1, Dublin 8

Children's Health Ireland

Paediatric Haematology Oncology, Cooley Road, Crumlin, Dublin

Cork University Hospital

Haematology Oncology, Wilton, T12 DC4A, Cork

Lithuania

1 site · Ongoing, recruiting

Vilniaus Universiteto Ligonine Santaros Klinikos Vsi

Center for Pediatric Oncology and Hematology, Santariskiu G. 7, Vilniaus M. Sav., Vilnius

Netherlands

2 sites · Ongoing, recruiting

Prinses Maxima Centrum voor Kinderoncologie B.V.

Hematology, Heidelberglaan 25, 3584 CS, Utrecht

Universitair Medisch Centrum Utrecht

Hematology, Heidelberglaan 100, 3584 CX, Utrecht

Norway

9 sites · Ongoing, recruiting

Universitetssykehuset Nord-Norge HF

Dept of Pediatrics, P. O. Box 100, 9038, Tromsoe

Universitetssykehuset Nord-Norge HF

Hematology, Sykehusvegen 38, 9019, Tromsoe

Oslo University Hospital HF

Hematology, P. O. Box 4950, 0424, Oslo

Helse Bergen HF

Hematology, Jonas Lies Vei 65, 5021, Bergen

St. Olavs Hospital HF

Hematology, Prinsesse Kristinas G. 3, 7030, Trondheim

St. Olavs Hospital HF

Dept of Pediatrics, P. O. Box 3250, Torgarden, Trondheim

Helse Stavanger HF

Hematology, Gerd-Ragna Bloch Thorsens Gate 8, 4011, Stavanger

Helse Bergen HF

Dept of Pediatrics, Jonas Lies Vei 65, 5021, Bergen

Oslo University Hospital HF

Ped.hemat-/onkology, P. O. Box 4950, 0424, Oslo

Portugal

3 sites · Ongoing, recruiting

Unidade Local De Saude De Coimbra E.P.E.

Hospital Pediátrico de Coimbra - Serviço de Oncologia Pediátrica, Avenida Afonso Romao, 3000-602, Coimbra

Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.

Serviço de Pediatria, Rua Professor Lima Basto, 1099-023, Lisbon

Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.

Serviço de Pediatria, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto

Spain

9 sites · Authorised, recruitment pending

University Hospital Virgen Del Rocio S.L.

Pediatric Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla

Hospital Universitari Vall D Hebron

Pediatric Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

Hospital Universitario Miguel Servet

Pediatric Oncology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza

Hospital Universitario De Cruces

Pediatric Oncology, Cruces Plaza S/n, 48903, Barakaldo

Hospital Universitario Y Politecnico La Fe

Pediatric Oncology, Avenida Fernando Abril Martorell 106, 46026, Valencia

Hospital Universitario La Paz

Pediatric Oncology, Paseo De La Castellana 261, 28046, Madrid

Hospital Infantil Universitario Nino Jesus

Pediatric Oncology, Avenida De Menendez Pelayo 65, 28009, Madrid

Hospital Sant Joan De Deu Barcelona

Pediatric Oncology, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat

University Hospital Son Espases

Pediatric Oncology, Carretera Valldemossa 79, 07120, Palma

Sweden

13 sites · Ongoing, recruiting

Region Oestergoetland

Avdelningen för hematolgi, S S:t Lars, S:t Larsgatan 49 B, Linkoping

Region Oestergoetland

Barncanceravdelningen, S S:t Lars, S:t Larsgatan 49 B, Linkoping

Region Oerebro lan

Avdelningen för hematologi, Sodra Grev Rosengatan, 701 85, Orebro

Region Skane - Skanes Universitetssjukhus

Barncanceravdelningen, Entregatan 7, Lunds Allhelgonafors, Lund

Region Stockholm – SLSO

Barncanceravdelningen, Solnavagen 1 E, S:t Matteus, Stockholm

Region Vasterbotten

Avdelningen för hematologi, Koksvagen 11, Alidhem, Umea

Region Uppsala

Avdelningen för hematologi, Storgatan 27, Uppsala Domkyrkofors., Uppsala

Region Stockholm – SLSO

Avdelningen för hematologi, Solnavagen 1 E, S:t Matteus, Stockholm

Region Uppsala

Barncanceravdelningen, Storgatan 27, Uppsala Domkyrkofors., Uppsala

Region Skane - Skanes Universitetssjukhus

Avdelningen för hematologi, Entregatan 7, Lunds Allhelgonafors, Lund

Region Vasterbotten

Barncanceravdelningen, Koksvagen 11, Alidhem, Umea

Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen

Barncancercentrum, Behandlingsvägen 7, 41650 Göteborg, Behandlingsvagen 7, Harlanda, Gothenburg

Sahlgrenska University Hospital-Vaestra Goetalandsregionen

Sektionen för hematologi och koagulation, Gröna Stråket 6, 41345 Göteborg, Bla Straket 5, Goteborgs Annedal, Goteborg

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Recruitment start
Belgium	2020-10-30	2020-10-30
Denmark	2020-07-27	2020-07-27
Estonia	2022-06-28	2022-06-28
Finland	2020-09-17	2020-09-17
France	2023-03-17	2023-03-17
Germany	2022-04-05	2022-04-05
Iceland	2022-11-09	2022-11-09
Ireland	2024-03-29	2024-03-29
Lithuania	2022-04-29	2022-04-29
Netherlands	2020-07-13	2020-07-13
Norway	2020-12-14	2020-12-14
Portugal	2023-01-20	2023-01-20
Sweden	2020-09-28	2020-09-28

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Serious breaches 3 · Art. 52 CTR

Serious breach SB-56790

Sponsor became aware: 2024-11-06
Date of breach: 2023-08-07
Submission date: 2024-11-19
Member states concerned: Iceland, Ireland, Belgium, Lithuania, Portugal, Denmark, Estonia, Finland, Sweden, France, Netherlands, Germany, Norway
Categories: Protocol
Areas impacted: Subject safety, Data reliability or robustness
Benefit-risk balance changed: Yes
Description: Patinet was incorrectly stratified according to the protocol. Was stratified to ALL IR-low instead of IR-high, which is a lower risk category affecting treatment.
Sponsor actions: Corrective action: Exit of the protocol.
Preventive action: Better understanding of the risk stratification in ALLTogether protocol.

Organisation	City	Country	Type
Centre Hospitalier Regional Universitaire De Tours	Tours	France	Clinical facility BE/BA

Serious breach SB-111966

Sponsor became aware: 2025-12-16
Date of breach: 2025-07-09
Submission date: 2025-12-18
Member states concerned: Iceland, Ireland, Belgium, Lithuania, Portugal, Denmark, Estonia, Finland, Sweden, France, Netherlands, Germany, Norway, Spain
Categories: Protocol
Areas impacted: Subject safety, Data reliability or robustness, Subject rights, Regulatory
Benefit-risk balance changed: No
Description: A stratification error occurred whereby the patient was assigned to the IR-HIGH group instead of the IR-LOW group.
Patients with high hyperdiploidy (HeH) and TP1 MRD between 3 × 10⁻⁴ and 4 × 10⁻⁴, together with a favorable copy number alteration (CNA) profile, should be classified as IR-LOW and not IR-HIGH.
As a consequence of this incorrect stratification, the patient (HeH with MRD TP1 = 3 × 10⁻⁴ and CNA good risk) was randomized to the R3 arm and received inotuzumab.

According to protocol AllTogether, the MRD threshold for defining favorable MRD in the HeH subgroup is set at 3 × 10⁻⁴, irrespective of the CNA profile.
Based on this wording, we initially considered that the criteria for treatment de-escalation were not fulfilled in this patient.
However, in patients with HeH, MRD between 3 × 10⁻⁴ and 5 × 10⁻⁴, and a favorable CNA profile, the criteria for inclusion in the IR-LOW group are in fact fulfilled.
Our initial interpretation was that CNA-based criteria and good-risk genetic features (HeH and ETV6-RUNX1) were mutually exclusive, with each subgroup benefiting from its own specific MRD threshold for de-escalation. This interpretation was reinforced by the presence of three distinct inclusion criteria for IR-LOW, including one specifically dedicated to HeH and ETV6-RUNX1, as well as by the wording “irrespective of the CNA profile” in the protocol.

The patient received treatment in the IR-HIGH arm with inotuzumab, which was well tolerated. No major toxicities or safety issues were observed. The event did not negatively affect the safety, rights, or well-being of the research participant.
Sponsor actions: In practice, this potential misclassification concerns only a very limited number of patients with HeH, MRD between 3 × 10⁻⁴ and 4 × 10⁻⁴, and a favorable CNA profile who may have been assigned to the IR-HIGH group. Given that the MRD threshold for de-escalation in ETV6-RUNX1 patients is higher than that used for CNA good-risk patients, this situation cannot occur in that subgroup. A review of all 103 patients included at our center was conducted to verify correct risk stratification.

For future patients with HeH, we will be particularly vigilant in integrating both MRD values and CNA risk status before validating assignment to the IR-HIGH group.
In addition, both the national and international Principal Investigators have been informed of this issue.
We propose clarifying the protocol wording by providing additional detail on de-escalation criteria for HeH, specifically by replacing the current sentence “HeH with TP1 < 0.03%” with:
“HeH with TP1 < 0.03% irrespective of CNA profile, or HeH with TP1 < 0.05% with a favorable CNA profile.” This would highlights that a higher MRD TP1 threshold is allowed for HeH patients with favorable CNA profile.
As currently written, this statement is ambiguous, as it combines criteria based on HeH with those based on a genetic subgroup that nevertheless includes HeH. This ambiguity led us to incorrectly assume that the latter criterion applied only to non-HeH patients.

Organisation	City	Country	Type
Trousseau Hospital	Paris	France	Clinical facility BE/BA

Serious breach SB-97072

Sponsor became aware: 2025-09-08
Date of breach: 2025-09-03
Submission date: 2025-09-09
Member states concerned: Iceland, Ireland, Belgium, Lithuania, Portugal, Denmark, Estonia, Finland, Sweden, France, Netherlands, Germany, Norway, Spain
Categories: Protocol
Areas impacted: Subject safety
Benefit-risk balance changed: No
Description: During a monitoring visit it was noticed that a patient had been erroneously included in the ALLTogether trial (by diagnosis T-lymphoblastic lymphoma) and also subsequently erroneously randomized in R3-TEAM. The randomization led to the patient being treated with the experimental drug, 6-thioguanine.
ALL-therapy is a valid and recommended treatment for T-LBL. If
the patient had not been included in the AllTogether cohort, he would have been treated with the ALL protocol in any case (in this case, with ALLTogether treatment drugs) in accordance with Finnish treatment practice. Although he received tioguanine in TEAM, there have been no problems associated with this experimental drug (which may have been beneficial or not to him).
Sponsor actions: The patient has been removed from the AllTogether and TEAM studies on September 5th, 2025 (he continues with normal
ALL maintenance treatment).
In the future, starting from now, at least two or three people will check that the patient meets the inclusion and exclusion criteria for the study. If there is any uncertainty (such as the bone marrow blast count in connection with LBL), the matter will be checked with the national PI.

Organisation	City	Country	Type
Oulu University Hospital	Oulu	Finland	Clinical facility BE/BA

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 994 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_ Asparaginase activity outcome SUS3 sub-study 2022-501050-11 redacted	N/A
Protocol (for publication)	D1_ALLTogether1 DS sub-protocol 2022-501050-11-01 redacted	5.1
Protocol (for publication)	D1_BM aspiration guideline 2022-501050-11 redacted	2.0
Protocol (for publication)	D1_BRAIN SUS2 sub-study 2022-501050-11 BE DK EE FI DE IE LT NL NO SE redacted	3.0
Protocol (for publication)	D1_CSF sampling and processing guideline 2022-501050-11 redacted	4.0
Protocol (for publication)	D1_CSF-FLOW SUS4 sub-study 2022-501050-11 BE DK FI FR DE IE LT NL NO PT SE redacted	2.0
Protocol (for publication)	D1_CSF-FLOW SUS4 sub-study lab manual 2022-501050-11 BE DK FI FR DE IE LT NL NO PT SE redacted	2.1
Protocol (for publication)	D1_FCM MRD guidelines 2022-501050-11 redacted	3.0
Protocol (for publication)	D1_Genetics screening guidelines 2022-501050-11 redacted	5.0
Protocol (for publication)	D1_InO sub-protocol 2022-501050-11 redacted	6.1
Protocol (for publication)	D1_Maintenance therapy SUS5 sub-study 2022-501050-11 BE DK EE FI FR DE IE LT NL NO PT SE redacted	2
Protocol (for publication)	D1_Master Protocol 2022-501050-11 redacted	6.1
Protocol (for publication)	D1_Molecular MRD guidelines 2022-501050-11 redacted	2.0
Protocol (for publication)	D1_TDM of Asparaginase guideline 2022-501050-11 redacted	3.1
Protocol (for publication)	D1_TEAM sub-protocol 2022-501050-11 redacted	5.1
Protocol (for publication)	D1_TKI Biology SUS1 sub-study 2022-501050-11 BE DK EE FI FR DE IS IE LT NL NO SE redacted	N/A
Protocol (for publication)	D1_TPMT and NUDT15 testing and dosing guideline 2022-501050-11 redacted	2.0
Protocol (for publication)	D3_DSMB Charter 2022-501050-11-01 redacted	3.0
Protocol (for publication)	D4_Patient facing document SUS2 SDQ Parent 4-17yr Swedish SE redacted	N/A
Protocol (for publication)	D4_Patient facing documents EQ-5D-5L Self-Complete SV SE redacted	1.1
Protocol (for publication)	D4_Patient facing documents EQ-5D-Y Paper Proxy1 ID 72657 SE SV redacted	1.0
Protocol (for publication)	D4_Patient facing documents EQ-5D-Y Paper Proxy2 ID 72660 SE SV redacted	1.0
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE1	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE10	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE11	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE12	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE13	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE14	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE15	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE16	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE17	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE18	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE19	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE2	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE20	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE21	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE22	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE23	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE24	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE25	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE26	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE27	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE28	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE29	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE3	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE30	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE31	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE32	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE33	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE34	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE35	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE36	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE4	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE5	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE6	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE7	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE8	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing BE9	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DE	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DE1	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DE2	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK1	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK10	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK11	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK12	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK13	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK14	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK15	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK16	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK17	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK2	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK3	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK4	1
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK5	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK6	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK7	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK8	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing DK9	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing EE	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing EE1	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing EE10	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing EE11	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing EE2	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing EE3	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing EE4	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing EE5	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing EE6	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing EE7	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing EE8	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing EE9	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing ES	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing ES1	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing ES2	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI1	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI10	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI11	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI12	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI13	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI14	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI15	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI16	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI17	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI18	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI19	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI2	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI20	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI21	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI22	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI23	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI24	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI25	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI26	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI27	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI3	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI4	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI5	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI6	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI7	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI8	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FI9	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FR	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FR1	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing FR2	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing IE	2.1
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing IE1	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing IE10	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing IE11	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing IE12	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing IE13	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing IE14	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing IE2	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing IE3	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing IE4	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing IE5	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing IE6	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing IE7	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing IE8	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing IE9	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing LT	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing LT1	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing LT10	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing LT2	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing LT3	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing LT4	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing LT5	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing LT6	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing LT7	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing LT8	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing LT9	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NL	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NL1	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NL10	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NL11	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NL12	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NL13	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NL14	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NL15	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NL16	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NL2	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NL3	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NL4	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NL5	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NL6	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NL7	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NL8	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NL9	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO1	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO10	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO11	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO12	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO13	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO14	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO15	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO16	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO17	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO18	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO19	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO2	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO20	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO21	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO22	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO23	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO24	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO25	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO26	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO27	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO3	1
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO4	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO5	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO6	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO7	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO8	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing NO9	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing PT	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing PT1	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing PT2	N/A
Protocol (for publication)	D4_Patient facing documents Justification for not disclosing SE	N/A
Protocol (for publication)	D4_Patient facing documents PedsQL Fatigue Parent 2-4 yr Swedish SE redacted	N/A
Protocol (for publication)	D4_Patient facing documents SUS2 BRIEF-P Parent 2-4yr Swedish SE redacted	N/A
Protocol (for publication)	D4_Patient facing documents SUS2 BRIEF2 Parent 5-17yr Swedish SE redacted	N/A
Protocol (for publication)	D4_Patient facing documents SUS2 BRIEFA 18yr Swedish SE redacted	N/A
Protocol (for publication)	D4_Patient facing documents SUS2 MEES 18yr Swedish SE redacted	N/A
Protocol (for publication)	D4_Patient facing documents SUS2 MEES Proxy 0-4yr Swedish SE redacted	N/A
Protocol (for publication)	D4_Patient facing documents SUS2 MEES Proxy 11-17 yr Swedish SE redacted	N/A
Protocol (for publication)	D4_Patient facing documents SUS2 MEES Proxy 5-7yr Swedish SE redacted	N/A
Protocol (for publication)	D4_Patient facing documents SUS2 MEES Proxy 8-10yr Swedish SE redacted	N/A
Protocol (for publication)	D4_Patient facing documents SUS2 PedsQL Core 18-25yr Swedish SE redacted	4.0
Protocol (for publication)	D4_Patient facing documents SUS2 PedsQL Core Acute Parent 13-18yr Swedish SE redacted	4.0
Protocol (for publication)	D4_Patient facing documents SUS2 PedsQL Core Acute Parent 2-4yr Swedish SE redacted	4.0
Protocol (for publication)	D4_Patient facing documents SUS2 PedsQL Core Acute Parent 5-7yr Swedish SE redacted	4.0
Protocol (for publication)	D4_Patient facing documents SUS2 PedsQL Core Acute Parent 8-12yr Swedish SE redacted	4.0
Protocol (for publication)	D4_Patient facing documents SUS2 PedsQL Core Parent 13-18yr Swedish SE redacted	4.0
Protocol (for publication)	D4_Patient facing documents SUS2 PedsQL Core Parent 2-4yr Swedish SE redacted	4.0
Protocol (for publication)	D4_Patient facing documents SUS2 PedsQL Core Parent 5-7yr Swedish SE redacted	4.0
Protocol (for publication)	D4_Patient facing documents SUS2 PedsQL Core Parent 8-12yr Swedish SE redacted	4.0
Protocol (for publication)	D4_Patient facing documents SUS2 PedsQL Fatigue 18-25 yr Swedish SE redacted	N/A
Protocol (for publication)	D4_Patient facing documents SUS2 PedsQL Fatigue Parent 13-18yr Swedish SE redacted	N/A
Protocol (for publication)	D4_Patient facing documents SUS2 PedsQL Fatigue Parent 5-7yr Swedish SE redacted	N/A
Protocol (for publication)	D4_Patient facing documents SUS2 PedsQL Fatigue Parent 8-12yr Swedish SE redacted	N/A
Protocol (for publication)	D4_Patient facing documents SUS2 PedsQL FIM Parent acute Swedish SE redacted	2.0
Protocol (for publication)	D4_Patient facing documents SUS2 SDQ 18yr Swedish SE redacted	N/A
Protocol (for publication)	D4_Patient facing documents SUS2 SDQ Parent 2-4yr Swedish SE redacted	N/A
Recruitment arrangements (for publication)	Assessed by NCA-EC under CTD	1
Recruitment arrangements (for publication)	Assessed by NCA-EC under CTD	1
Recruitment arrangements (for publication)	Assessed by NCA-EC under CTD	1
Recruitment arrangements (for publication)	Assessed by NCA-EC under CTD	1
Recruitment arrangements (for publication)	K1_ALLTogether1_Recruitment arrangements_Belgium 2022-501050-11-01	1.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements	2
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1.0
Recruitment arrangements (for publication)	K1_recruitment arrangements	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements NO	1
Recruitment arrangements (for publication)	K1_Recruitment Arrangements NO	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements SE	N/A
Recruitment arrangements (for publication)	K1_Recruitment Arrangements_Germany	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements_I	1.0
Recruitment arrangements (for publication)	K1_Recruitment Arrangements_Ireland	2.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements_PT	2
Recruitment arrangements (for publication)	K1_Recruitment arrangements_public	1
Subject information and informed consent form (for publication)	ICF ALLTogether1 BRAIN A-haara Potilas yli 18v redacted	1
Subject information and informed consent form (for publication)	ICF ALLTogether1 BRAIN B-haara Potilas yli 18v redacted	1.0
Subject information and informed consent form (for publication)	ICF ALLTogether1 BRAIN B-haara yli 18v Huoltaja redacted	1
Subject information and informed consent form (for publication)	L1__SIS and ICF R3 InO 12-17y	1.2
Subject information and informed consent form (for publication)	L1_Assent DS subprotocol 12-15 yrs PT	2.1
Subject information and informed consent form (for publication)	L1_Assent Maintenance substudy 12-15 yrs PT	1.2
Subject information and informed consent form (for publication)	L1_Assent Master trial 12-15 yrs PT	2.2
Subject information and informed consent form (for publication)	L1_Assent R1 subprotocol 12-15 yrs PT	2.1
Subject information and informed consent form (for publication)	L1_Assent R2 subprotocol 12-15 yrs PT	2.1
Subject information and informed consent form (for publication)	L1_Assent R3 subprotocol InO TEAM 12-15 yrs PT	2.1
Subject information and informed consent form (for publication)	L1_Assent R3 TEAM subprotocol 12-15 yrs PT	2.1
Subject information and informed consent form (for publication)	L1_Assent TKI subprotocol 12-15 yrs PT	2.1
Subject information and informed consent form (for publication)	L1_ICF ALLTogeter1 SUS5 Maintenance Potilas 11-14v redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether Brain A-haara Huoltaja Redacted	3.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether Brain B-haara Huoltaja Redacted	3.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether Rekisterointi biopankki osallistuminen Huoltaja Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether Rekisterointi biopankki osallistuminen Potilas 11-14v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether Rekisterointi biopankki osallistuminen Potilas 6-10v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether Rekisterointi biopankki osallistuminen Potilas yli 18v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether SUS2 BRAIN A-haara Potilas 11-14v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether SUS2 BRAIN A-haara Potilas 15-17 Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether SUS2 BRAIN A-haara Potilas 6-10v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether SUS2 BRAIN B-haara Potilas 11-14v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether SUS2 BRAIN B-haara Potilas 15-17 Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether SUS2 BRAIN B-haara Potilas 6-10v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether SUS4 CSF-Flow Huoltaja redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 Ino Team Potilas 11-14v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 NRI1 TKI Huoltaja Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 NRI1 TKI Potilas 11-14v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 NRI1 TKI Potilas 6-10v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 NRI1 TKI Potilas yli 18v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 NRI2 DS Blina Potilas yli 18v Redacted	4.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 NRI2 DS Blina Vanhemmat Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 NRI2 Potilas 11-14v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 NRI2 Potilas 15-17v DS Blina Redacted	4.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 NRI2 Potilas 6-10v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R1 Huoltaja Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R1 Potilas 11-14v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R1 Potilas 15-17v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R1 Potilas 6-10v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R2 Huoltaja Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R2 Potilas 11-14v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R2 Potilas 15-17v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R2 Potilas 6-10v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R3 Ino potilas 11-14v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R3 Ino Potilas 6-10v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R3 Ino Team Potilas 6-10v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R3 Kaksihaarainen Ino Huoltaja Redacted	3.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R3 Kaksihaarainen Ino yli 18-v Redacted	3.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R3 Kaksihaarainen Team Huoltaja Redacted	3.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R3 Kaksihaarainen Team yli 18-v Redacted	3.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R3 Kolmihaarainen Huoltaja Redacted	4.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R3 Team Potilas 11-14v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 R3 Team Potilas 6-10v Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 Reg biobank deltagande Patient 15-17 ar	4.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 Reg biobank deltagande Patient 18 ar	4.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 Reg biobank deltagande Vardnadshavare	4.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 SUS3 Asparaginaasi alle 15v huoltaja redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 SUS3 Asparaginaasi Potilas 15-17v redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 SUS4 CSF-Flow Potilas 11-14v redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 SUS4 CSF-Flow Potilas 6-10v redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 SUS5 Maintenance Huoltaja redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 SUS5 Maintenance Potilas 6-10 v redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF ALLTogether1 SUS5 Maintenance Potilas yli 18v redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF DS subprotocol 16-17 yrs PT	2.2
Subject information and informed consent form (for publication)	L1_ICF DS subprotocol parents PT	2.2
Subject information and informed consent form (for publication)	L1_ICF Maintenance substudy 16-17 yrs PT	1.3
Subject information and informed consent form (for publication)	L1_ICF Maintenance substudy parents PT	1.4
Subject information and informed consent form (for publication)	L1_ICF Master trial 16-17 yrs PT	3.3
Subject information and informed consent form (for publication)	L1_ICF Master trial parents PT	3.4
Subject information and informed consent form (for publication)	L1_ICF Master trial parents PT_EN	2.4
Subject information and informed consent form (for publication)	L1_ICF pregnancy FU parents PT	1.1
Subject information and informed consent form (for publication)	L1_ICF pregnancy FU pregnant person PT	1.1
Subject information and informed consent form (for publication)	L1_ICF pregnancy_newborn FU partner PT	1.0
Subject information and informed consent form (for publication)	L1_ICF R1 subprotocol 16-17 yrs PT	3.2
Subject information and informed consent form (for publication)	L1_ICF R1 subprotocol parents PT	3.2
Subject information and informed consent form (for publication)	L1_ICF R2 subprotocol 16-17 yrs PT	3.3
Subject information and informed consent form (for publication)	L1_ICF R2 subprotocol parents PT	3.3
Subject information and informed consent form (for publication)	L1_ICF R2 subprotocol parents PT_EN	3.2
Subject information and informed consent form (for publication)	L1_ICF R3 InO TEAM subprotocol 16-17 yrs PT	3.2
Subject information and informed consent form (for publication)	L1_ICF R3 InO TEAM subprotocol parents PT	3.2
Subject information and informed consent form (for publication)	L1_ICF R3 TEAM subprotocol 16-17 yrs PT	3.2
Subject information and informed consent form (for publication)	L1_ICF R3 TEAM subprotocol parents PT	3.2
Subject information and informed consent form (for publication)	L1_ICF TKI subprotocol 16-17 yrs PT	3.2
Subject information and informed consent form (for publication)	L1_ICF TKI subprotocol parents PT	3.2
Subject information and informed consent form (for publication)	L1_ICF_ BRAIN_arm B_Patient18_Redacted	1.2
Subject information and informed consent form (for publication)	L1_ICF_13-17 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_7-12_years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_Blina_13-17 years_redacted	5.0
Subject information and informed consent form (for publication)	L1_ICF_Blina_18-24 years_redacted	5.0
Subject information and informed consent form (for publication)	L1_ICF_Blina_7-12 years_redacted	5.0
Subject information and informed consent form (for publication)	L1_ICF_Blina_caregiver_redacted	5.0
Subject information and informed consent form (for publication)	L1_ICF_Brain_13-17 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_Brain_7-12 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_BRAIN_arm A_12-17y_Redacted	2.2
Subject information and informed consent form (for publication)	L1_ICF_BRAIN_Arm A_Parents_Redacted	2.2
Subject information and informed consent form (for publication)	L1_ICF_BRAIN_arm A_Patient18_Redacted	1.2
Subject information and informed consent form (for publication)	L1_ICF_BRAIN_arm B _Parents18_Redacted	1.1
Subject information and informed consent form (for publication)	L1_ICF_BRAIN_arm B_12-17y_Redacted	2.2
Subject information and informed consent form (for publication)	L1_ICF_BRAIN_arm B_Parents_Redacted	2.2
Subject information and informed consent form (for publication)	L1_ICF_Brain_caregiver_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_Brain_LT_13-17 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_Brain_LT_7-12 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_Brain_LT_adult patient caregiver_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_Brain_LT_caregiver_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_Brain_LT_redacted	6.0
Subject information and informed consent form (for publication)	L1_ICF_Brain_redacted	6.0
Subject information and informed consent form (for publication)	L1_ICF_caregiver_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_CSF-FLOW_12-17y_Redacted	4.1
Subject information and informed consent form (for publication)	L1_ICF_CSF-FLOW_Parents_Redacted	4.1
Subject information and informed consent form (for publication)	L1_ICF_Maintenance therapy_12-17y_Redacted	4.2
Subject information and informed consent form (for publication)	L1_ICF_Maintenance therapy_Parents_Redacted	4.2
Subject information and informed consent form (for publication)	L1_ICF_maintenance_13-17 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_maintenance_7-12 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_maintenance_caregiver_redacted	6.0
Subject information and informed consent form (for publication)	L1_ICF_maintenance_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_Master_12-17y_Redacted	5.2
Subject information and informed consent form (for publication)	L1_ICF_Master_Parents_Redacted	5.2
Subject information and informed consent form (for publication)	L1_ICF_MRD_13-17 years_redacted	5.0
Subject information and informed consent form (for publication)	L1_ICF_MRD_7-12 years_redacted	5.0
Subject information and informed consent form (for publication)	L1_ICF_MRD_caregiver_redacted	5.0
Subject information and informed consent form (for publication)	L1_ICF_MRD_redacted	5.0
Subject information and informed consent form (for publication)	L1_ICF_NRI2_Downs_Basic_Ireland_Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF_NRI2_Downs_Standard_Ireland_Redacted	2.0
Subject information and informed consent form (for publication)	L1_ICF_Pregnancy Monitoring Partner_Redacted	1.1
Subject information and informed consent form (for publication)	L1_ICF_Pregnancy Monitoring Patients_Redacted	1.1
Subject information and informed consent form (for publication)	L1_ICF_pregnancy_partner_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_pregnancy_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R1_12-17y_Redacted	5.2
Subject information and informed consent form (for publication)	L1_ICF_R1_13-15 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R1_7-12 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R1_caregiver_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R1_Parents_Redacted	5.2
Subject information and informed consent form (for publication)	L1_ICF_R2_12-17y_Redacted	5.2
Subject information and informed consent form (for publication)	L1_ICF_R2_13-15 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R2_7-12 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R2_caregiver_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R2_Parents_Redacted	5.2
Subject information and informed consent form (for publication)	L1_ICF_R3_Ino_12-17y_Redacted	5.2
Subject information and informed consent form (for publication)	L1_ICF_R3_Ino_13-17 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R3_Ino_7-12 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R3_Ino_caregiver_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R3_Ino_Parents_Redacted	5.2
Subject information and informed consent form (for publication)	L1_ICF_R3_Ino_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R3_Ino_Team_12-17y_Redacted	5.2
Subject information and informed consent form (for publication)	L1_ICF_R3_Ino_team_13-17 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R3_Ino_team_7-12 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R3_Ino_team_caregiver_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R3_Ino_Team_Parents_Redacted	5.2
Subject information and informed consent form (for publication)	L1_ICF_R3_Ino_team_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R3_TEAM_12-17y_Redacted	5.2
Subject information and informed consent form (for publication)	L1_ICF_R3_Team_13-17 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R3_Team_7-12 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R3_Team_caregiver_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_R3_TEAM_Parents_Redacted	5.2
Subject information and informed consent form (for publication)	L1_ICF_R3_Team_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_TKI_12-17y_Redacted	5.2
Subject information and informed consent form (for publication)	L1_ICF_TKI_13-17 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_TKI_7-12 years_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_TKI_caregiver_redacted	6
Subject information and informed consent form (for publication)	L1_ICF_TKI_Parents_Redacted	5.2
Subject information and informed consent form (for publication)	L1_ICF_TKI_redacted	6
Subject information and informed consent form (for publication)	L1_ICF-SIS_NRI2_Downs_Parents_Ireland_Redacted	2.0
Subject information and informed consent form (for publication)	L1_INFO ALLTogether1 SUS3 Asparaginaasi yli 15v huoltaja redacted	2.0
Subject information and informed consent form (for publication)	L1_PIS ALLTogether Rekisterointi biopankki osallistuminen yli 18-v Redacted	4.0
Subject information and informed consent form (for publication)	L1_PIS ALLTogether1 BRAIN A-haara Potilas yli 18 Redacted	1
Subject information and informed consent form (for publication)	L1_PIS ALLTogether1 Rekisterointi biopankki osallistuminen Huoltaja Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether Brain A-haara Huoltaja Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether Brain B-haara Huoltaja Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether SUS2 BRAIN A-haara Potilas 15-17v Redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether SUS2 BRAIN B-haara Potilas 15-17v Redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 CSF-Flow Patienter 15-17 ar redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 CSF-Flow Patienter 18ar redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 CSF-Flow Vardnadshavare redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 NRI2 DS Blina Huoltaja Redacted	4.1
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 NRI2 DS Blina Potilas 18-45v Redacted	4.1
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 NRI2 Potilas 15-17v DS Blina Redacted	4.1
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 R1 Huoltaja Redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 R2 HuoltajaRedacted	3.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 R3 Kaksihaarainen INO Huoltaja Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 R3 Kaksihaarainen Ino yli 18-v Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 R3 Kaksihaarainen Team Huoltaja Redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 R3 Kaksihaarainen Team yli 18-v Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 R3 Kolmihaarainen Huoltaja Redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 SUS3 Asparaginaasi Huoltaja redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 SUS3 Asparaginaasi Potilas 10-14v redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 SUS3 Asparaginaasi Potilas 15-17v redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 SUS3 Asparaginaasi Potilas 6-9v redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 SUS4 CSF-Flow Huoltaja redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 SUS5 Maintenance Huoltaja redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 SUS5 Maintenance Potilas yli 18v redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 TKI interventio Huoltaja redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS ALLTogether1 TKI interventio yli 18-v Redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [BlinaDS_Parents PMC] redacted	4.1
Subject information and informed consent form (for publication)	L1_SIS and ICF [BlinaDS_UMCU_Parents] redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [BRAIN A_Jongeren va16 PMC] redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [BRAIN A_Kinderen12-15 PMC] redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [BRAIN A_Parents PMC] redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [BRAIN B_Jongeren va16 PMC] redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [BRAIN B_Jongeren va18_PMC] redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF [BRAIN B_Kinderen12-15 PMC] redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [BRAIN B_Parents 2-15 PMC] redacted	2.1
Subject information and informed consent form (for publication)	L1_SIS and ICF [BRAIN B_Parents bij 16_PMC] redacted	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF [BRAIN B_Parents bij 18_PMC] redacted	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF [BRAIN-A main_UMCU jongvolw_UMCU] redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [BRAIN-B longitudinaal_UMCU jongvolw_UMCU] redacted	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [extraMRD_DS_PMC] redacted	2.2
Subject information and informed consent form (for publication)	L1_SIS and ICF [extraMRD_Jongeren_va16] redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF [extraMRD_Kinderen12-15] redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF [extraMRD_Parents] redacted	4.2
Subject information and informed consent form (for publication)	L1_SIS and ICF [extraMRD_UMCU_DS] redacted	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [extraMRD_UMCU_jongvolw] redacted	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [Maintenance_DS_PMC] redacted	1.3
Subject information and informed consent form (for publication)	L1_SIS and ICF [Maintenance_Jongeren va16] redacted	2.3
Subject information and informed consent form (for publication)	L1_SIS and ICF [Maintenance_Kinderen12-15_PMC] redacted	2.3
Subject information and informed consent form (for publication)	L1_SIS and ICF [Maintenance_Parents_PMC] redacted	3.3
Subject information and informed consent form (for publication)	L1_SIS and ICF [Maintenance_UMCU_DS] redacted	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [MASTER_DS_Parents_PMC] redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [MASTER_Jongeren va16_PMC] redacted	6.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [MASTER_Kinderen12-15_PMC] redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [MASTER_Parents_PMC] redacted	7.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [MASTER_UMCU DS] redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [MASTER_UMCU jongvolw] redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [PregnancyMonitoringPartner_Jongeren va16_PMC] redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF [PregnancyMonitoringPartner_Kinderen 12-15_PMC] redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF [PregnancyMonitoringPartner_Parents_PMC] redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF [PregnancyMonitoringPartner_UMCU jongvolw] redacted	2.3
Subject information and informed consent form (for publication)	L1_SIS and ICF [PregnancyMonitoringPatient_Parents_PMC] redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF [PregnancyMonitoringPatient_UMCU jongvolw] redacted	2.2
Subject information and informed consent form (for publication)	L1_SIS and ICF [PregnancyMonitoringPatient_UMCU_Parents] redacted	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF [PregnancyMonPatient_Jongeren va16] redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF [PregnancyMonPatient_Kinderen12-15] redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF [PrePIFIC UMCU_jongvolw] redacted	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF [R1_Jongeren va16_PMC] redacted	2.1
Subject information and informed consent form (for publication)	L1_SIS and ICF [R1_Jongeren va16_PMC] redacted CORRECT	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [R1_Kinderen12-15_PMC] redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [R1_Parents_PMC] redacted	2.1
Subject information and informed consent form (for publication)	L1_SIS and ICF [R1_Parents_PMC] redacted CORRECT	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [R2_Jongeren va16_PMC] redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [R2_Kinderen12-15_PMC] redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [R2_Parents_PMC] redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [R3-2arm InO_Jongeren va16_PMC] redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [R3-2arm InO_Kinderen12-15_PMC] redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [R3-2arm InO_Parents_PMC] redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [R3-2arm InO_UMCU_jongvolw] redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [R3-2arm TEAM_UMCU_jongvolw] redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [R3-2armTEAM_jongeren va16] redacted	2.1
Subject information and informed consent form (for publication)	L1_SIS and ICF [R3-2armTEAM_jongeren va16] redacted CORRECT	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [R3-2armTEAM_kinderen12-15] redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [R3-2armTEAM_Parents] redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [R3-3arm_Jongeren va16] redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [R3-3arm_Kinderen12-15] redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [R3-3arm_Parents] redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [R3-3arm_UMCU_jongvolw] redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [TKI_Jongeren va16_PMC] redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [TKI_Kinderen12-15_PMC] redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [TKI_Parents_PMC] redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF [TKI_UMCU jongvolw_UMCU] redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF 10-13y_redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF 14-17y_redacted	5
Subject information and informed consent form (for publication)	L1_SIS and ICF 18y_reconsent_redacted	4
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 Blinatumomab 15-45 ar redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 Blinatumomab 8-14 ar	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 Blinatumomab Vardnadshavare redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 BRAIN Patienter 15-17 ar redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 BRAIN Patienter 8-14 ar	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 BRAIN Patienter over 18 ar redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 BRAIN Vardnadshavare redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 CSF-Flow Patienter 8-14 ar	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 Endast reg biobank Vardnadshavare-Pat 18ar	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 Graviditet Partner redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 Graviditet Patient redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 Maintenance Patienter 15-17ar redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 Maintenance Patienter 18ar redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 Maintenance Patienter 8-14 ar	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 Maintenance Vardnadshavare redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R1 Patienter 15 ar redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R1 Patienter 8-14 ar	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R1 samykkisbla redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R1 upplysingabla redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R1 Vardnadshavare redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R2 Patienter 15 ar redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R2 Patienter 8-14 ar	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R2 samykkisbla redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R2 upplysingabla redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R2 Vardnadshavare redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3 2-arm Ino upplysingabla V3 Redacted correct	3.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3 2-arm Inotuzumab samykkisbla redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3 2-arm Inotuzumab upplysingabla redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3 2-arm TEAM samykkisbla redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3 2-arm TEAM upplysingabla redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3 3-arm InO og TEAM samykkisbla redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3 3-arm InO og TEAM upplysingabla redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3 TEAM 2-arm Patienter 15-17 ar redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3 TEAM 2-arm Patienter 18ar redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3 TEAM 2-arm Patienter 8-14 ar	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3 TEAM 2-arm Vardnadshavare redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3 Team Potilas 15-17v Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3 TEAM-InO 3-arm 15-17 ar redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3 TEAM-InO 3-arm 8-14 ar	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3 TEAM-InO 3-arm Vardnadshavare redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3-InO 2-arm Patienter 15-17 ar redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3-InO 2-arm Patienter 18 ar redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3-InO 2-arm Patienter 8-14 ar	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 R3-InO 2-arm Vardnadshavare redacted	5.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 Registrering biobank deltagande Patienter 8-14 ar	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 TKI samykkisbla redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 TKI Patienter 15-17 ar redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 TKI Patienter 18ar redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 TKI Patienter 8-14 ar	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 TKI upplysingabla redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 TKI Vardnadshavare redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 upplysingabla til foreldra redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 upplysingabla til foreldra redacted correct	3
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 upplyst samykki adalrannsokn Redacted correct	3
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 upplyst samykki foreldrar redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 Utokad MRD EOC Patienter 15-17 ar	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 Utokad MRD EOC Patienter 18ar	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 Utokad MRD EOC Patienter 8-14 ar	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ALLTogether1 Utokad MRD EOC Vardnadshavare	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ICF Pregnancy monitoring Partner redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF ICF Pregnancy monitoring Patients redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF Master 12-17y	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Master Adults_public	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Master Parents_public	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF parents_redacted	6.1
Subject information and informed consent form (for publication)	L1_SIS and ICF PIS Pregnancy monitoring Partner redacted	N/A
Subject information and informed consent form (for publication)	L1_SIS and ICF PIS Pregnancy monitoring Patient redacted	N/A
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregn Partner 12-17y	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregn Partner Adults_public	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregn Partner Parents_public	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregn Pat 12-17y	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregn Pat Adult	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Pregn Pat Parents	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF R1 12-17y	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF R1 Adults_public	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF R1 Parents_public	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF R2 Adults_public	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF R2 Parents_public	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF R2 Patients 12-17y	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF R3 Comb 12-17y	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF R3 combi Adults_public	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF R3 combi Parents_public	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF R3 InO Adults_public	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF R3 InO Parents_public	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF R3 TEAM 12-17y	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF R3 TEAM Adults_public	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF R3 TEAM Parents_public	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Samykkisbla Blinatumomab DS foreldrar redacted	1.0
Subject information and informed consent form (for publication)	L1_SIS and ICF TKI 12-17y	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF TKI Adults_public	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF TKI Parents_public	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF until 9y_redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF Upplysingabla Blinatumomab DS foreldrar redacted	N/A
Subject information and informed consent form (for publication)	L1_SIS and ICF_ Pregnancy_15 Years and Under_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_BRAIN_Arm_A_10-13y_redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF_BRAIN_Arm_A_14-17y_redacted	3.1
Subject information and informed consent form (for publication)	L1_SIS and ICF_BRAIN_Arm_A_parents_redacted	4.1
Subject information and informed consent form (for publication)	L1_SIS and ICF_BRAIN_Arm_A_until 9y_redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF_CSF-FLOW 10-13y_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_CSF-FLOW 14-17y_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_CSF-FLOW parents_redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_CSF-FLOW_until 9y_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_DE_biobanking_from 14yr_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_DE_biobanking_parents_redacted	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF_DE_BRAIN_Arm A_from 18yr_redacted	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Adult_Blina Down_Redacted	3.1
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Adult_BRAIN Arm A_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Adult_BRAIN Arm B_Redacted	2.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Adult_Maintenance_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Adult_Master_Redacted	4.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Adult_R1_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Adult_R2_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Adult_R3_2 arm Ino_Redacted	4.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Adult_R3_2 arm TEAM_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Adult_R3_3 arm_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Adult_TKI_Redacted	4.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Parent to Adult_BRAIN Arm B_Redacted	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Parent_Blina Down_Redacted	3.1
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Parent_BRAIN Arm A_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Parent_BRAIN Arm B_Redacted	2.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Parent_Maintenance_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Parent_Master_Redacted	4.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Parent_R1_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Parent_R2_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Parent_R3_2 arm Ino_Redacted	4.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Parent_R3_2 arm TEAM_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Parent_R3_3 arm_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Parent_TKI_Redacted	4.2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Pregnancy_Partner_Redacted	4.1
Subject information and informed consent form (for publication)	L1_SIS and ICF_DK_Pregnancy_Patient_Redacted	4.1
Subject information and informed consent form (for publication)	L1_SIS and ICF_DS_from 12y_redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_DS_parents_redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF_DS_until 11y_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Extended_MRD_Adults_Ireland_Redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Extended_MRD_Age_13_to_15_Ireland_Redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Extended_MRD_Age_7_to_12_Ireland_Redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Extended_MRD_Parents_Ireland_Redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Follow Up_parents_redacted	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Master Protocol Registration_13 to 15 Years_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Master Protocol Registration_7 to 12 Years_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Master Protocol Registration_Adults_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Master Protocol Registration_For Parents_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_NRI1_ABL Class_13 to 15 years_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_NRI1_ABL Class_7 to 12 years_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnancy_Adults_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnancy_For Parent of Partner_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnancy_For Parent_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnancy_Partner_15 Years and Under_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnancy_Partner_For Adult_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_R1_10-13y_V1_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_R1_14-17y_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_R1_parents_redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF_R1_until 9y_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_R2_10-13y_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_R2_14-17y_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_R2_parents_redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF_R2_until 9y_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_R3 Randomisation InO and TEAM_13 to 15 Years_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_R3 Randomisation InO and TEAM_7 to 12 Years_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_R3 Randomisation InO and TEAM_For Adults_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_R3 Randomisation InO and TEAM_For Parents_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_R3 Randomisation TEAM_13 to 15_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_R3 Randomisation TEAM_7 to 12_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_R3 Randomisation TEAM_For Adults_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_R3 Randomisation TEAM_For Parents_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_R3_10-13y_redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF_R3_14-17y_redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF_R3_parents_InO und TEAM_redacted	5
Subject information and informed consent form (for publication)	L1_SIS and ICF_R3_parents_nur TEAM_redacted	5
Subject information and informed consent form (for publication)	L1_SIS and ICF_R3_until 9y_redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_Randomisation 1_13 to 15_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Randomisation 1_7 to 12_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Randomisation 1_For Adults_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Randomisation 1_For Parent(s)_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Randomisation 2_13 to 15_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Randomisation 2_7 to 12_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Randomisation 2_For Adults_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Randomisation 2_For Parent(s)_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Randomisation 3_INO_13 to 15_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Randomisation 3_INO_7 to 12_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Randomisation 3_INO_For Adult_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Randomisation 3_INO_For Parents_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Sub_Dauertherapie_10-13y_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Sub_Dauertherapie_14-17y_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Sub_Dauertherapie_parents_redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_Sub_Dauertherapie_until 9 y_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Sub_MRD_10-13y_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Sub_MRD_14-17y_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Sub_MRD_parents_redacted	3
Subject information and informed consent form (for publication)	L1_SIS and ICF_Sub_MRD_Patienteninfo_until 9y_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_SUS1_NRI1_ABL Class_Adults_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_SUS1_NRI1_Parents_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_SUS2_Longitudinal Brain_Arm_B_For Adults_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_SUS2_Longitudinal Brain_Arm_B_For Age 13 to 15 Years_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_SUS2_Longitudinal Brain_Arm_B_For Age 7 to 12 Years_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_SUS2_Longitudinal Brain_Arm_B_For Parents_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_SUS2_MainBrain_ArmA_Age_13 to 15 years_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_SUS2_MainBrain_ArmA_Age_7 to 12_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_SUS2_MainBrain_ArmA_For Adults_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_SUS2_MainBrain_ArmA_For_Parents_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_SUS4_CSF Flow_13 to 15 Years of Age_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_SUS4_CSF Flow_7 to 12 Years of Age_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_SUS5_Maintenance Therapy_13 to 15 Years_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_SUS5_Maintenance Therapy_7 to 12 Years_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_SUS5_Maintenance Therapy_For Adults_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_SUS5_Maintenance Therapy_For Parents_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_TKI_10-13y_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_TKI_14-17y_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_TKI_parents_redacted	4
Subject information and informed consent form (for publication)	L1_SIS BRAIN-A_7-12ar redacted	3
Subject information and informed consent form (for publication)	L1_SIS BRAIN-B_7-12ar redacted	1
Subject information and informed consent form (for publication)	L1_SIS CARt_7-12ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS CSF-flow_7-12ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS DS subprotocol 16-17 yrs PT	2.2
Subject information and informed consent form (for publication)	L1_SIS DS subprotocol 8-11 yrs PT	2.0
Subject information and informed consent form (for publication)	L1_SIS DS subprotocol parents PT	2.2
Subject information and informed consent form (for publication)	L1_SIS ICF ALLTogether1 NRI1 TKI Potilas 15-17v Redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS ICF_13-17ans_CSF flow	1.0
Subject information and informed consent form (for publication)	L1_SIS ICF_13-17ans_generale	3.0
Subject information and informed consent form (for publication)	L1_SIS ICF_13-17ans_ITK	3.0
Subject information and informed consent form (for publication)	L1_SIS ICF_13-17ans_Maint	1.0
Subject information and informed consent form (for publication)	L1_SIS ICF_13-17ans_R1	1.1
Subject information and informed consent form (for publication)	L1_SIS ICF_13-17ans_R2	1.1
Subject information and informed consent form (for publication)	L1_SIS ICF_13-17ans_R3 LAL B	2.0
Subject information and informed consent form (for publication)	L1_SIS ICF_13-17ans_R3 LAL T	2.0
Subject information and informed consent form (for publication)	L1_SIS ICF_13-17ans_T21 Blina	1.0
Subject information and informed consent form (for publication)	L1_SIS ICF_7-12 ans_generale	1.1
Subject information and informed consent form (for publication)	L1_SIS ICF_7-12 ans_ITK	2.0
Subject information and informed consent form (for publication)	L1_SIS ICF_7-12 ans_Maint	1.0
Subject information and informed consent form (for publication)	L1_SIS ICF_7-12 ans_R1	1.1
Subject information and informed consent form (for publication)	L1_SIS ICF_7-12 ans_R2	1.1
Subject information and informed consent form (for publication)	L1_SIS ICF_7-12 ans_R3	1.1
Subject information and informed consent form (for publication)	L1_SIS ICF_7-12 ans_T21 blina	1.1
Subject information and informed consent form (for publication)	L1_SIS ICF_AP_Blina T21	1.1
Subject information and informed consent form (for publication)	L1_SIS ICF_AP_CSF flow	1.0
Subject information and informed consent form (for publication)	L1_SIS ICF_AP_generale	3.0
Subject information and informed consent form (for publication)	L1_SIS ICF_AP_ITK	3.0
Subject information and informed consent form (for publication)	L1_SIS ICF_AP_Maint	1.0
Subject information and informed consent form (for publication)	L1_SIS ICF_AP_R1	2.0
Subject information and informed consent form (for publication)	L1_SIS ICF_AP_R2	1.1
Subject information and informed consent form (for publication)	L1_SIS ICF_AP_R3 LAL B	2.0
Subject information and informed consent form (for publication)	L1_SIS ICF_AP_R3 LAL T	2.0
Subject information and informed consent form (for publication)	L1_SIS ICF_CSF-Flow_7-12 ans	1.0
Subject information and informed consent form (for publication)	L1_SIS ICF_majeur_R3_LAL B	1.0
Subject information and informed consent form (for publication)	L1_SIS ICF_majeur_R3_LAL T	1.0
Subject information and informed consent form (for publication)	L1_SIS ICF_poursuite_CSF flow	1
Subject information and informed consent form (for publication)	L1_SIS ICF_Poursuite_generale	3.0
Subject information and informed consent form (for publication)	L1_SIS ICF_Poursuite_ITK	3.0
Subject information and informed consent form (for publication)	L1_SIS ICF_poursuite_LAL B	2.0
Subject information and informed consent form (for publication)	L1_SIS ICF_poursuite_Maint	1.0
Subject information and informed consent form (for publication)	L1_SIS ICF_poursuite_R1	1.1
Subject information and informed consent form (for publication)	L1_SIS ICF_poursuite_R2	1.1
Subject information and informed consent form (for publication)	L1_SIS ICF_Poursuite_R3 LAL T	2.0
Subject information and informed consent form (for publication)	L1_SIS ICF_poursuite_T21 Blina T21	1.1
Subject information and informed consent form (for publication)	L1_SIS ICF_suivi grossesse	1.0
Subject information and informed consent form (for publication)	L1_SIS Maintenance substudy 16-17 yrs PT	1.1
Subject information and informed consent form (for publication)	L1_SIS Maintenance substudy 8-11 anos PT	1.1
Subject information and informed consent form (for publication)	L1_SIS Maintenance substudy parents PT	1.1
Subject information and informed consent form (for publication)	L1_SIS Master trial 16-17 yrs PT	3.1
Subject information and informed consent form (for publication)	L1_SIS Master trial 8-11 yrs PT	2.1
Subject information and informed consent form (for publication)	L1_SIS Master trial parents PT	3.0
Subject information and informed consent form (for publication)	L1_SIS Master trial parents PT_EN	2.1
Subject information and informed consent form (for publication)	L1_SIS Master trial under 8 yrs PT	2.0
Subject information and informed consent form (for publication)	L1_SIS MasterReg_7-12ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS pregnancy over 16 years PT	1.0
Subject information and informed consent form (for publication)	L1_SIS pregnancy parents PT	1.0
Subject information and informed consent form (for publication)	L1_SIS R1 R2 R3 TKI subprotocols 8-11 yrs PT	2.0
Subject information and informed consent form (for publication)	L1_SIS R1 subprotocol 16-17 yrs PT	3.1
Subject information and informed consent form (for publication)	L1_SIS R1 subprotocol parents PT	3.1
Subject information and informed consent form (for publication)	L1_SIS R1_7-12ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS R2 subprotocol 16-17 yrs PT	3.2
Subject information and informed consent form (for publication)	L1_SIS R2 subprotocol parents PT	3.2
Subject information and informed consent form (for publication)	L1_SIS R2 subprotocol parents PT_EN	3.1
Subject information and informed consent form (for publication)	L1_SIS R2_7-12ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS R3 InO TEAM subprotocol 16-17 yrs PT	3.1
Subject information and informed consent form (for publication)	L1_SIS R3 InO TEAM subprotocol parents PT	3.1
Subject information and informed consent form (for publication)	L1_SIS R3 TEAM subprotocol 16-17 yrs PT	3.1
Subject information and informed consent form (for publication)	L1_SIS R3 TEAM subprotocol parents PT	3.1
Subject information and informed consent form (for publication)	L1_SIS R3_TEAM_7-12ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS Registration_ALLTogether1 children 12-17y_EN_public	4.0
Subject information and informed consent form (for publication)	L1_SIS Registration_ALLTogether1 children 8-11_EN_public	4.0
Subject information and informed consent form (for publication)	L1_SIS Registration_ALLTogether1 deelnemers 18j en ouder_NL_public	4.0
Subject information and informed consent form (for publication)	L1_SIS Registration_ALLTogether1 Enfants 8-11a_FR_public	4.0
Subject information and informed consent form (for publication)	L1_SIS Registration_ALLTogether1 kinderen 12-17j_NL_public	4.0
Subject information and informed consent form (for publication)	L1_SIS Registration_ALLTogether1 kinderen 8-11j_NL_Public	4.0
Subject information and informed consent form (for publication)	L1_SIS Registration_ALLTogether1 ouders_NL_public	4.0
Subject information and informed consent form (for publication)	L1_SIS Registration_ALLTogether1 parents_EN_public	4.0
Subject information and informed consent form (for publication)	L1_SIS Registration_ALLTogether1 Parents_FR_public	4.0
Subject information and informed consent form (for publication)	L1_SIS Registration_ALLTogether1 participants from 18y_EN_public	4.0
Subject information and informed consent form (for publication)	L1_SIS Registrering biobank deltagande Patienter 15-17 ar redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS Registrering biobank deltagande Patienter 18 ar redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS Registrering biobank deltagande Vardnadshavare redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS SamtykkeBlina_7-12ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS TKI subprotocol 16-17 yrs PT	3.1
Subject information and informed consent form (for publication)	L1_SIS TKI subprotocol parents PT	3.1
Subject information and informed consent form (for publication)	L1_SIS TKI_7-12ar redacted	3
Subject information and informed consent form (for publication)	L1_SIS Vedlikehold_7-12ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS_Blina_ALLTOGETHER1_children 12y and older_EN_public	2.0
Subject information and informed consent form (for publication)	L1_SIS_Blina_ALLTOGETHER1_Enfants 12a et plus_FR_public	2.0
Subject information and informed consent form (for publication)	L1_SIS_Blina_ALLTOGETHER1_Kinderen vanaf 12j_NL_public	2.0
Subject information and informed consent form (for publication)	L1_SIS_Blina_ALLTOGETHER1_Ouders_NL_public	2.0
Subject information and informed consent form (for publication)	L1_SIS_Blina_ALLTOGETHER1_Parents_EN_public	2.0
Subject information and informed consent form (for publication)	L1_SIS_Blina_ALLTOGETHER1_Parents_FR_public	2.0
Subject information and informed consent form (for publication)	L1_SIS_DK_10-14 yr_BRAIN Arm A	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_10-14 yr_BRAIN Arm B	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_10-14 yr_Maintenance	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_10-14 yr_Master	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_10-14 yr_R1	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_10-14 yr_R2	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_10-14 yr_R3_2 arm Ino	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_10-14 yr_R3_2 arm TEAM	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_10-14 yr_R3_3 arm	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_10-14 yr_TKI	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_15-17 yr_Blina Down_Redacted	3.1
Subject information and informed consent form (for publication)	L1_SIS_DK_15-17 yr_BRAIN Arm A_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS_DK_15-17 yr_BRAIN Arm B_Redacted	2.2
Subject information and informed consent form (for publication)	L1_SIS_DK_15-17 yr_Maintenance_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS_DK_15-17 yr_Master_Redacted	4.2
Subject information and informed consent form (for publication)	L1_SIS_DK_15-17 yr_R1_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS_DK_15-17 yr_R2_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS_DK_15-17 yr_R3_2 arm Ino_Redacted	4.2
Subject information and informed consent form (for publication)	L1_SIS_DK_15-17 yr_R3_2 arm TEAM_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS_DK_15-17 yr_R3_3 arm_Redacted	3.2
Subject information and informed consent form (for publication)	L1_SIS_DK_15-17 yr_TKI_Redacted	4.2
Subject information and informed consent form (for publication)	L1_SIS_DK_5-9 yr_BRAIN Arm A	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_5-9 yr_BRAIN Arm B	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_5-9 yr_Maintenance	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_5-9 yr_Master	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_5-9 yr_R1	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_5-9 yr_R2	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_5-9 yr_R3_2 arm Ino	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_5-9 yr_R3_2 arm TEAM	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_5-9 yr_R3_3 arm	1.1
Subject information and informed consent form (for publication)	L1_SIS_DK_5-9 yr_TKI	1.1
Subject information and informed consent form (for publication)	L1_SIS_Extended_MRD_Age_6_and_under_Ireland_Redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS_Imatinib_ALLTOGETHER1_Children 12-17y_EN_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_Imatinib_ALLTOGETHER1_Deelnemers 18j en ouder_NL_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_Imatinib_ALLTOGETHER1_Enfants 12-17a_FR_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_Imatinib_ALLTOGETHER1_Kinderen 12-17j_NL_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_Imatinib_ALLTOGETHER1_Ouders_NL_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_Imatinib_ALLTOGETHER1_Parents_EN_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_Imatinib_ALLTOGETHER1_Parents_FR_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_Imatinib_ALLTOGETHER1_Participants 18a et plus_FR_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_Imatinib_ALLTOGETHER1_Participants from 18y_EN_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_Master Protocol Registration_6 Years and Under_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS_NRI1_ABL Class_6 years and under_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS_NRI2_Downs_Basic_Ireland_Redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS_NRI2_Downs_Standard_Ireland_Redacted	2.0
Subject information and informed consent form (for publication)	L1_SIS_R1_ALLTogether1_Children 12-17y_EN_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_R1_ALLTogether1_Deelnemers 18j en ouder_NL_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_R1_ALLTogether1_Enfants 12-17a_FR_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_R1_ALLTogether1_Kinderen 12-17j_NL_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_R1_ALLTogether1_Ouders_NL_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_R1_ALLTogether1_Parents_EN_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_R1_ALLTogether1_Parents_FR_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_R1_ALLTogether1_Participants 18a et plus_FR_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_R1_ALLTogether1_Participants from 18y_EN_public	3.0
Subject information and informed consent form (for publication)	L1_SIS_R2_ALLTOGETHER1_Children 12-17y_EN_public	2.0
Subject information and informed consent form (for publication)	L1_SIS_R2_ALLTOGETHER1_Deelnemers 18j en ouder_NL_public	2.0
Subject information and informed consent form (for publication)	L1_SIS_R2_ALLTOGETHER1_Enfants 12-17a_FR_public	2.0
Subject information and informed consent form (for publication)	L1_SIS_R2_ALLTOGETHER1_Kinderen 12-17j_NL_public	2.0
Subject information and informed consent form (for publication)	L1_SIS_R2_ALLTOGETHER1_Ouders_NL_public	2.0
Subject information and informed consent form (for publication)	L1_SIS_R2_ALLTOGETHER1_Parents_EN_public	2.0
Subject information and informed consent form (for publication)	L1_SIS_R2_ALLTOGETHER1_Parents_FR_public	2.0
Subject information and informed consent form (for publication)	L1_SIS_R2_ALLTOGETHER1_Participants 18a et plus_FR_public	2.0
Subject information and informed consent form (for publication)	L1_SIS_R2_ALLTOGETHER1_Participants from 18y_EN_public	2.0
Subject information and informed consent form (for publication)	L1_SIS_R3 Randomisation InO and TEAM_Age 6 Years and Under_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3 Randomisation TEAM_Age 6 Years and Under_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_BCPALL_ALLTOGETHER1_Children 12-17y_EN_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_BCPALL_ALLTOGETHER1_Deelnemers 18j en ouder_NL_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_BCPALL_ALLTOGETHER1_Enfants 12-17a_FR_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_BCPALL_ALLTOGETHER1_Kinderen 12-17j_NL_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_BCPALL_ALLTOGETHER1_Ouders_NL_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_BCPALL_ALLTOGETHER1_Parents_EN_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_BCPALL_ALLTOGETHER1_Parents_FR_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_BCPALL_ALLTOGETHER1_Participants 18a et plus_FR_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_BCPALL_ALLTOGETHER1_Participants from 18y_EN_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_TALL_ALLTOGETHER1_Children 12-17y_EN_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_TALL_ALLTOGETHER1_Deelnemers 18j en ouder_NL_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_TALL_ALLTOGETHER1_Enfants 12-17a_FR_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_TALL_ALLTOGETHER1_Kinderen 12-17j_NL_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_TALL_ALLTOGETHER1_Ouders_NL_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_TALL_ALLTOGETHER1_Parents_EN_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_TALL_ALLTOGETHER1_Parents_FR_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_TALL_ALLTOGETHER1_Participants 18a_FR_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_R3_TALL_ALLTOGETHER1_Participants from 18y_EN_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_Randomisation 1_6 Years and Under_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS_Randomisation 2_6 Years and Under_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS_Randomisation 3_INO_6 Years and Under_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS_Registration_ALLTogether1 Enfants 12-17a_FR_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_Registration_ALLTogether1 Participants 18a et plus_FR_public	4.0
Subject information and informed consent form (for publication)	L1_SIS_SUS2_Longitudinal Brain_Arm_B_Age_6 and Under_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS_SUS2_MainBrain_ArmA_Age_6 and under_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS_SUS4_CSF Flow_For 6 Years and Under_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS_SUS4_CSF Flow_For Adult_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS_SUS4_CSF Flow_For Parents_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS_SUS5_Maintenance Therapy_6 Years and Under_Ireland_Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS-ICF ALLTogether Rekisterointi biopankki osallistuminen Potilas 15-17v Redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS-ICF ALLTogether1 R3 Ino Potilas 15-17v Redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS-ICF ALLTogether1 R3 Ino Team Potilas 15-17v Redacted	4.0
Subject information and informed consent form (for publication)	L1_SIS-ICF ALLTogether1 SUS4 CSF-Flow Potilas 15-17v redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS-ICF ALLTogether1 SUS5 Maintenance Potilas 15-17v redacted	3.0
Subject information and informed consent form (for publication)	L1_SIS-ICF BLINA DS 18-45 ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF BRAIN A 18-45 ar redacted	4
Subject information and informed consent form (for publication)	L1_SIS-ICF BRAIN B 18-45 ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF BRAIN B Foresatte Redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF BRAIN-A_12-18ar redacted	3
Subject information and informed consent form (for publication)	L1_SIS-ICF BRAIN-A_Foresatte redacted	4
Subject information and informed consent form (for publication)	L1_SIS-ICF BRAIN-B_12-18ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF CAR-T 18-25 ar redacted	3
Subject information and informed consent form (for publication)	L1_SIS-ICF CARt_12-18ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF CARt_Foresatte	2.1
Subject information and informed consent form (for publication)	L1_SIS-ICF CSF-flow 18-45 ar redacted	2a
Subject information and informed consent form (for publication)	L1_SIS-ICF CSF-flow_12-18ar redacted	4
Subject information and informed consent form (for publication)	L1_SIS-ICF CSF-flow_Foresatte redacted	4
Subject information and informed consent form (for publication)	L1_SIS-ICF Graviditet 18-45 ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF Graviditet hos partner 18-45 ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF MASTER 18-45 ar redacted	4
Subject information and informed consent form (for publication)	L1_SIS-ICF MasterReg_12-18ar redacted	3
Subject information and informed consent form (for publication)	L1_SIS-ICF MasterRegForesatte redacted	3
Subject information and informed consent form (for publication)	L1_SIS-ICF R1_12-18ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF R1_Foresatte redacted	3
Subject information and informed consent form (for publication)	L1_SIS-ICF R2_12-18ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF R2_Foresatte redacted	3
Subject information and informed consent form (for publication)	L1_SIS-ICF R3 InO 18-45 ar redacted	2a
Subject information and informed consent form (for publication)	L1_SIS-ICF R3 TEAM 18-45 ar redacted	1
Subject information and informed consent form (for publication)	L1_SIS-ICF R3_InO_12-18ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF R3_InO_7-12ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF R3_InO_Foresatte redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF R3_InOTEAM_12-18ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF R3_InOTEAM_7-12ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF R3_InOTEAM_Foresatte redacted	3
Subject information and informed consent form (for publication)	L1_SIS-ICF R3_TEAM_12-18ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF R3_TEAM_Foresatte redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF SamtykkeBlina_12-18ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF SamtykkeBlinaForesatte redacted	4
Subject information and informed consent form (for publication)	L1_SIS-ICF TKI 18-45 ar redacted	3
Subject information and informed consent form (for publication)	L1_SIS-ICF TKI_12-18ar redacted	3
Subject information and informed consent form (for publication)	L1_SIS-ICF TKI_Foresatte redacted	3
Subject information and informed consent form (for publication)	L1_SIS-ICF Vedlikehold_12-18ar redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF Vedlikehold_Foresatte redacted	2
Subject information and informed consent form (for publication)	L1_SIS-ICF Vedlikeholdsbehandling 18-45 ar redacted	2a
Subject information and informed consent form (for publication)	L2_Other subject information material_Patient Rights Leaflet_Redacted	1.0
Subject information and informed consent form (for publication)	L2_TKI_additional information_10-13y_redacted	1
Subject information and informed consent form (for publication)	L2_TKI_additional information_14-17y_redacted	1
Subject information and informed consent form (for publication)	L2_TKI_additional information_parents_redacted	2
Subject information and informed consent form (for publication)	L2_TKI_additional information_until 9y_redacted	1
Subject information and informed consent form (for publication)	PIS ALLTogether1 BRAIN B-haara Potilas yli 18v redacted	1
Subject information and informed consent form (for publication)	PIS ALLTogether1 BRAIN B-haara yli 18v Huoltaja redacted	2.0
Subject information and informed consent form (for publication)	PIS ALLTogether1 R1 15-17 v redacted	4.0
Subject information and informed consent form (for publication)	PIS ALLTogether1 R2 15-17 v redacted	4.0
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Blinatumomab	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Cytarabine	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Dexamethasone	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Dexamethasone (comparator)	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Doxorubicin	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Hydrocortisone sodium phosphate	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Hydrocortisone sodium succinate	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Imatinib	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Inotuzumab ozogamicin	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Mercaptopurine oral solution	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Mercaptopurine oral solution	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Mercaptopurine tablets	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Mercaptopurine tablets	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Methotrexate i.t.	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Methotrexate tablet	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Methotrexate tablets	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Methylprednisolone sodium succinate	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmpC Prednisolone sodium succinate redacted	007
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Tioguanine	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Vincristine	N/A
Summary of Product Characteristics (SmPC) (for publication)	E2_SmpC Vincristine (test)	N/A
Synopsis of the protocol (for publication)	D1_Protocol synopsis French BE 2022-501050-11-01	6.1
Synopsis of the protocol (for publication)	D1_Protocol synopsis Dutch BE 2022-501050-11-01	6.1
Synopsis of the protocol (for publication)	D1_Protocol Synopsis EN 2022-501050-11-01	6.1
Synopsis of the protocol (for publication)	D1_Protocol synopsis ES 2022-501050-11-01 CLEAN	6.1
Synopsis of the protocol (for publication)	D1_Protocol Synopsis FI 2022-501050-11-01	6.1
Synopsis of the protocol (for publication)	D1_Protocol Synopsis FR 2022-501050-11-01	6.1
Synopsis of the protocol (for publication)	D1_Protocol synopsis German BE 2022-501050-11-01	6.1
Synopsis of the protocol (for publication)	D1_Protocol Synopsis IS 2022-501050-11-01	6.1
Synopsis of the protocol (for publication)	D1_Protocol Synopsis national FR 2022-501050-11-01	3.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis NL 2022-501050-11-01	6.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis NL 2022-501050-11-01_the hospital website synopsis	6.0
Synopsis of the protocol (for publication)	D1_Protocol Synopsis NO 2022-501050-11-01	6.1
Synopsis of the protocol (for publication)	D1_Protocol Synopsis PT 2022-501050-11-01	6.1
Synopsis of the protocol (for publication)	D1_Protocol Synopsis PT 2022-501050-11-01_full	6.1
Synopsis of the protocol (for publication)	D1_Protocol synopsis SE SV 2022-501050-11-01	6.1

Application history

9 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-09-12	Sweden	Acceptable 2024-10-15	2024-10-15
2	SUBSTANTIAL MODIFICATION	SM-1	2025-03-26	Sweden	Acceptable 2025-06-23	2025-06-24
3	SUBSTANTIAL MODIFICATION	SM-2	2025-09-05		Acceptable	2025-10-06
4	SUBSEQUENT ADDITION OF MSC	APP-4	2025-09-17		Acceptable 2025-06-23	2025-12-11
5	SUBSTANTIAL MODIFICATION	SM-3	2025-09-24		Acceptable	2025-10-21
6	SUBSTANTIAL MODIFICATION	SM-4	2025-10-15		Acceptable	2025-11-07
7	NON SUBSTANTIAL MODIFICATION	NSM-2	2025-12-12		Acceptable	2025-12-12
8	NON SUBSTANTIAL MODIFICATION	NSM-3	2025-12-17		Acceptable	2025-12-17
9	SUBSTANTIAL MODIFICATION	SM-5	2026-01-22	Sweden	Acceptable 2026-03-27	2026-03-27

A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia

Overview

Key facts

External identifiers

Trial design

Main objective

Secondary objectives 5

Conditions and MedDRA coding

Regulatory references

Eligibility criteria

Inclusion criteria 9

Exclusion criteria 15

Endpoints

Primary endpoints 3

Secondary endpoints 19

Investigational products

Test 18

Comparator 3

Sponsors and contacts

Karolinska University Hospital

Scientific contact point

Public contact point

Third parties 11

Locations

By country

Investigational sites

Country notifications

Oversight and notifications

Serious breaches 3 · Art. 52 CTR

Results and documents

Documents 994 files

Application history

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