IntReALL BCP 2020 – International Study for Treatment of Childhood Relapsed Precursor B-cell ALL 2020

2023-509392-17-00 Protocol IntReALL BCP 2020 Therapeutic confirmatory (Phase III) Authorised, recruitment pending

Status Authorised, recruitment pending · 12 EU/EEA countries · 91 sites · Protocol IntReALL BCP 2020

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Authorised, recruitment pending
Participants planned 795
Countries 12
Sites 91

Relapsed Acute Lymphoblastic Leukemia (ALL)

SR Arm induction:Improvement of EFS probability with InO versus ALLR3-Mitox SR-MRD good response consolidation: Improvement of 4 years DFS with 3 courses of blinatumomab HR Arm with CR2 consolidation: DFS non-inferiority with one consolidation chemotherapy course HC1 before blinatumomab compared to historical controls …

Key facts

Sponsor
Charite Universitaetsmedizin Berlin KöR
Participant type
Pediatric, Patients
Age range
0-17 years, 18-64 years
Gender
Male and Female
Therapeutic area
Diseases [C] - Hemic and Lymphatic Diseases [C15], Diseases [C] - Neoplasms [C04]
Decision date (initial)
2025-12-14
Transition trial
No
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
Yes
Funding sources
European Commission · National Funding Organsisation (e.g. Deutsche Kinderkrebshilfe)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

SR Arm induction:Improvement of EFS probability with InO versus ALLR3-Mitox
SR-MRD good response consolidation: Improvement of 4 years DFS with 3 courses of blinatumomab
HR Arm with CR2 consolidation: DFS non-inferiority with one consolidation chemotherapy course HC1 before blinatumomab compared to historical controls with 2 consolidation courses HC1 and 2
Isolated extramedullary relapses: EFS improvement with blinatumomab in late consolidation compared to historical controls

Secondary objectives 15

  1. SR Arm induction: Improvement of overall survival (OS) probability with the InO arm
  2. SR Arm induction: Improvement of MRD negative CR2 rates in the InO arm
  3. SR Arm induction: Reduction of patients requiring allo-HSCT in the InO arm
  4. SR Arm induction: Reduction of toxicity during induction in the InO arm
  5. SR Arm induction: Comparison of CD19+ cell recovery after SCB1 prior to Blinatumomab between patients given either InO or SOC
  6. SR-MRD good response consolidation: Improvement of OS as compared to historical controls (i.e. patients treated in the IntReALL SR 2010 arm B without epratuzumab)
  7. SR-MRD good response consolidation: Reduction of toxicity during and after blinatumomab as compared to historical controls
  8. HR with CR2 consolidation: Reduction of persisting MRD post HC1 with blinatumomab
  9. HR with CR2 consolidation: Improved rates of allo-HSCT in CR2 with negative MRD
  10. HR with CR2 consolidation: Improvement of OS as compared to historical controls
  11. HR with CR2 consolidation: Reduction of toxicity during consolidation therapy
  12. Isolated extramedullary relapses: Prognostic relevance of submicroscopic BM involvement at relapse diagnosis in IEM relapse
  13. Isolated extramedullary relapses: Improvement of OS as compared to historical controls
  14. Isolated extramedullary relapses: Prognostic relevance of MRD response after induction in MRD positive patients
  15. Pharmacokinetic parameters of InO

Conditions and MedDRA coding

Relapsed Acute Lymphoblastic Leukemia (ALL)

VersionLevelCodeTermSystem organ class
20.0 HLT 10024290 Leukaemias acute lymphocytic 10029104

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 22

  1. All study questions: Confirmed diagnosis of 1st relapsed B-cell precursor ALL
  2. Specific for HR consolidation arm: M1/CR2 after induction therapy
  3. All study questions: Patients ≥ 1 year and less than 18 years of age at diagnosis of primary ALL and less than 21 years of age at date of inclusion into the study
  4. Specific for HR consolidation arm: CD19 positive ALL at relapse (>10%)
  5. Specific for IEM arm: Histology or cytology proven extramedullary relapse
  6. Specific for IEM arm: No bone marrow involvement (M1 at relapse diagnosis) and bone marrow MRD <1%
  7. Specific for IEM arm: CD19 positive ALL at relapse (>10%)
  8. All study questions: Patient enrolled in a participating center
  9. All study questions: Written informed consent (IC)
  10. All study questions: Start of treatment falling into the study period
  11. Meeting SR criteria: No previous history of veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS)
  12. All study questions: No participation in other clinical trials 30 day prior to study enrolment that interfere with this protocol, except trials for primary ALL
  13. Specific for SR induction randomization: Meeting SR criteria
  14. Meeting SR criteria: BM involvement (≥ 1% leukemic blasts)
  15. Meeting SR criteria: CD22 positive ALL (>80% confirmed by flow-cytometry)
  16. Specific for SR MRD poor response consolidation: Meeting SR criteria with bone marrow involvement at relapse diagnosis
  17. Specific for SR MRD poor response consolidation: M1/CR2 and MRD ≥ 10-4 after induction
  18. Specific for SR MRD poor response consolidation: CD19 positive ALL at relapse (>10%)
  19. Specific for SR MRD good response consolidation: Meeting SR criteria with bone marrow involvement at relapse diagnosis
  20. Specific for SR MRD good response consolidation: M1/CR2 and MRD < 10-4 after induction
  21. Specific for SR MRD good response consolidation: CD19 positive ALL at relapse (>10%)
  22. Specific for HR consolidation arm: Meeting HR or VHR (in case of no possibility to be treated with CAR T cells) criteria

Exclusion criteria 22

  1. Known hypersensitivity to the active substances or excipients of the IMP’s or the SOC drugs, except to PEG-asparaginase which can be replaced by Erwinase
  2. Relapse post chimeric antigen receptor T-cell (CAR-T) therapy
  3. The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
  4. Objection to the study participation by a minor patient
  5. Patients in a dependent or subordinate relationship to the investigator or site staff (e.g. employees, relatives, or students)
  6. Specific for SR induction randomization: Prior confirmed severe (grade 3 or 4) or ongoing VOD/SOS
  7. Specific for SR induction randomization: Serious ongoing hepatic disease (e.g., cirrhosis, active hepatitis) not related to the current ALL relapse or current diagnostic/therapeutic measures
  8. Specific for SR induction randomization: ALT > 2,5 x ULN (at relapse diagnosis before start of cytoreduction) and/or bilirubin > 1.5 x ULN
  9. No consent is given for saving and propagation of pseudonymized medical data for study reasons
  10. Left ventricular ejection fraction (LVEF) < 50% or fractional shortening < 25%, and/or current or prior treatment for cardiomyopathy and/or history of clinically significant arrhythmias
  11. Severe concomitant disease that, according to the treating physician, does not allow treatment according to the protocol at the investigator’s discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
  12. Subjects unwilling or unable to comply with the study procedures
  13. Subjects who are legally detained in an official institute
  14. Pregnancy or positive pregnancy test in female patients (urine sample positive for β-HCG > 10 U/l) at screening or within 7 days prior to the initiation of study treatment
  15. Sexually active adolescents and adults not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
  16. Women not willing to refrain from Bbreast feeding until 12 months after end of anti-leukemic therapy
  17. Relapse post allogeneic HSCT
  18. Patients with any concurrent medical condition, laboratory abnormality, concomitant treatment, or comorbidity that, in the investigator’s clinical judgment would- compromise the patient’s ability to safely receive or tolerate inotuzumab ozogamicin and/or blinatumomab - significantly interfere with assessment of treatment efficacy or safety - make it unlikely that the patient would derive clinical benefit from protocol therapy - preclude adherence to study procedures or follow-up requirements
  19. Specific for SR induction randomization: Patients with intolerance to PEG-asparagniase and also to Erwinase are stratified to the inotuzumab arm
  20. Specific for SR induction randomization: Patients with insufficient expression of CD22 (< 80%) on leukemic blasts, they are assigned to the control chemotherapy arm
  21. Specific for blinatumomab treatment: Clinically relevant CNS pathology requiring treatment (eg, unstable epilepsy)
  22. Specific for blinatumomab treatment: Evidence of current CNS (CNS 2, CNS 3) involvement by ALL. Subjects with CNS relapse at the time of relapse are eligible if CNS is successfully treated prior to enrollment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

  1. SR induction: Event-free survival (EFS)
  2. SR-MRD good response consolidation: DFS
  3. HR with CR2 consolidation: DFS
  4. IEM: EFS

Secondary endpoints 14

  1. SR induction: MRD negativity rate after induction
  2. SR induction: Proportion of patients requiring allo-HSCT
  3. SR induction: OS
  4. SR induction: Toxicity (assessed by CTCAE grades and SAE reports)
  5. SR induction: Rate of patients with CD19 positive cells after SCB1 prior to Blinatumomab
  6. SR-MRD good response consolidation: OS
  7. SR-MRD good response consolidation: Toxicity (quantified by CTCAE grades and SAE reports)
  8. HR with CR2 consolidation: OS
  9. HR with CR2 consolidation: MRD negativity rates before allo-HSCT
  10. HR with CR2 consolidation: allo-HSCT rates
  11. IEM: EFS by MRD at relapse diagnosis (cut-off 10-4)
  12. IEM: OS
  13. IEM: DFS by MRD after induction (cut-off 10-4) in patients with BM MRD > 10e-4 at relapse
  14. Serum pharmacokinetic parameters of InO (Cmax and Ctrough)

Investigational products

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

Test 2

Inotuzumab Ozogamicin

SUB33081 · Substance

Active substance
Inotuzumab Ozogamicin
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
0.8 mg/m2 milligram(s)/square meter
Max total dose
1.8 mg/m2 milligram(s)/square meter
Max treatment duration
4 Week(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
Substance synonyms
MT-103, MEDI-538, MT103, Recombinant antibody derivative against human CD19 and CD3
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
15 µg/ m2 microgram(s)/ sq. Meter
Max total dose
1.69 mg/m2 milligram(s)/sq. meter
Max treatment duration
12 Week(s)
Authorisation status
Authorised
ATC code
L01FX07 — -
Marketing authorisation
EU/1/15/1047/001
MA holder
AMGEN EUROPE B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Comparator 18

Oncaspar 750 U/ml powder for solution for injection/infusion

PRD6822247 · Product

Active substance
Pegaspargase
Substance synonyms
PEG-Asparaginase, PEG-L-Asparaginase
Pharmaceutical form
POWDER FOR SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
1000 Other
Max total dose
7000 Other
Max treatment duration
7 Day(s)
Authorisation status
Authorised
ATC code
L01XX24 — PEGASPARGASE
Marketing authorisation
EU/1/15/1070/002
MA holder
LES LABORATOIRES SERVIER (SURESNES)
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

ELDISINE® 5 mg Pulver zur Herstellung einer Injektionslösung Vindesinsulfat

PRD1965638 · Product

Active substance
Vindesine Sulfate
Substance synonyms
VINDESINE SULPHATE
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
3 mg/m2 milligram(s)/sq. meter
Max total dose
12 mg/m2 milligram(s)/sq. meter
Max treatment duration
4 Day(s)
Authorisation status
Authorised
ATC code
L01CA03 — VINDESINE
Marketing authorisation
839.01.00
MA holder
STADAPHARM GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vincristine Sulfate 1 mg/ml solution for injection

PRD11830369 · Product

Active substance
Vincristine Sulfate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
2 mg milligram(s)
Max total dose
14 mg milligram(s)
Max treatment duration
9 Day(s)
Authorisation status
Authorised
ATC code
L01CA02 — VINCRISTINE
Marketing authorisation
PL 04515/0008
MA holder
HOSPIRA UK LIMITED,WALTON OAKS
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Methotrexate

SUB08856MIG · Substance

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

Cytarabin Accord 100 mg/ml Injektions-/Infusionslösung

PRD1167930 · Product

Active substance
Cytarabine
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
200 mg/m2 milligram(s)/square meter
Max total dose
1400 mg/m2 milligram(s)/square meter
Max treatment duration
4 Day(s)
Authorisation status
Authorised
ATC code
L01BC01 — CYTARABINE
Marketing authorisation
88149.00.00
MA holder
ACCORD HEALTHCARE B.V.
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Thioguanin "Aspen" 40mg Tabletten

PRD981313 · Product

Active substance
Tioguanine
Substance synonyms
Thioguanine anhydrous, THIOGUANINE, 6-THIOGUANINE
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
2240 µg/ m2 microgram(s)/ sq. Meter
Max treatment duration
4 Week(s)
Authorisation status
Authorised
ATC code
L01BB03 — TIOGUANINE
Marketing authorisation
16.354
MA holder
ASPEN PHARMA TRADING LIMITED
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Methotrexate

SUB08856MIG · Substance

Active substance
Methotrexate
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
40 mg/m2 milligram(s)/sq. meter
Max total dose
4240 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

Etoposide 20 mg/ml Concentrate for Solution for Infusion

PRD11213472 · Product

Active substance
Etoposide
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS ADMINISTRATION
Max daily dose
150 mg/m2 milligram(s)/sq. meter
Max total dose
1100 mg/m2 milligram(s)/sq. meter
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
L01CB01 — ETOPOSIDE
Marketing authorisation
PA2315/201/001
MA holder
ACCORD HEALTHCARE IRELAND LIMITED
MA country
Ireland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cytarabine Accord Healthcare 20 mg/ml injektio-/infuusioneste, liuos

PRD11981672 · Product

Active substance
Cytarabine
Substance synonyms
ARA-C, CYTOSINE ARABINOSIDE
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRATHECAL USE
Max daily dose
30 mg milligram(s)
Max total dose
600 mg milligram(s)
Max treatment duration
16 Day(s)
Authorisation status
Authorised
ATC code
L01BC01 — CYTARABINE
Marketing authorisation
34948
MA holder
ACCORD HEALTHCARE B.V.
MA country
Finland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

DEXAMETHASONE MEDISOL 8 mg/2 ml, solution injectable

PRD10092713 · Product

Active substance
Dexamethasone Phosphate
Substance synonyms
DEXAMETHASONE 21-(DIHYDROGEN PHOSPHATE)
Pharmaceutical form
SOLUTON FOR INJECTION
Route of administration
ORAL
Max daily dose
20 mg/m2 milligram(s)/sq. meter
Max total dose
1120 mg/m2 milligram(s)/sq. meter
Max treatment duration
8 Week(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
34009 302 640 9 6
MA holder
MEDISOL
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Zavedos® 5 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung Wirkstoff: Idarubicinhydrochlorid

PRD11830267 · Product

Active substance
Idarubicin Hydrochloride
Substance synonyms
4-DEMETHOXYDAUNORUBICIN HYDROCHLORIDE
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS ADMINISTRATION
Max daily dose
6 mg/m2 milligram(s)/sq. meter
Max total dose
24 mg/m2 milligram(s)/sq. meter
Max treatment duration
4 Day(s)
Authorisation status
Authorised
ATC code
L01DB06 — IDARUBICIN
Marketing authorisation
19345.00.00
MA holder
PFIZER PHARMA GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cyclophosphamid beta 500 mg/ml Konzentrat zur Herstellung einer Injektions-/Infusionslösung

PRD10049049 · Product

Active substance
Cyclophosphamide
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
1000 mg/m2 milligram(s)/sq. meter
Max total dose
4400 mg/m2 milligram(s)/sq. meter
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
L01AA01 — CYCLOPHOSPHAMIDE
Marketing authorisation
2205439.00.00
MA holder
BETAPHARM ARZNEIMITTEL GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Mercaptopurine 50mg tablets

PRD11749208 · Product

Active substance
Mercaptopurine
Substance synonyms
MERCAPTOPURINE ANHYDROUS, 3,7-DIHYDROPURINE-6-THIONE, 6-MERCAPTOPURINE, 6MP
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
50 mg/m2 milligram(s)/sq. meter
Max total dose
40000 mg/m2 milligram(s)/sq. meter
Max treatment duration
104 Week(s)
Authorisation status
Authorised
ATC code
L01BB02 — MERCAPTOPURINE
Marketing authorisation
PL 0142/1328
MA holder
ACCORD-UK LIMITED
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Daunoblastin 20 mg Pulver zur Herstellung einer Infusions- oder Injektionslösung

PRD11825203 · Product

Active substance
Daunorubicin Hydrochloride
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
35 mg/m2 milligram(s)/sq. meter
Max total dose
70 mg/m2 milligram(s)/sq. meter
Max treatment duration
2 Day(s)
Authorisation status
Authorised
ATC code
L01DB02 — DAUNORUBICIN
Marketing authorisation
15.778
MA holder
PFIZER CORPORATION AUSTRIA GES.M.B.H.
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Mitoxantrone 2 mg/ml concentrate for solution for infusion

PRD2334187 · Product

Active substance
Mitoxantrone
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
10 mg/m2 milligram(s)/sq. meter
Max total dose
20 mg/m2 milligram(s)/sq. meter
Max treatment duration
2 Day(s)
Authorisation status
Authorised
ATC code
L01DB07 — MITOXANTRONE
Marketing authorisation
PL 20075/0412
MA holder
ACCORD HEALTHCARE LIMITED
MA country
United Kingdom
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Solu-Dacortin 250 mg Pulver und Lösungsmittel zur Herstellung einer Injektionslösung oder Infusionslösung

PRD10168902 · Product

Active substance
Prednisolone Sodium Succinate
Substance synonyms
PREDNISOLONE HEMISUCCINATE SODIUM SALT, PREDNISOLON-21-HYDROGENSUCCINAT NATRIUM
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRATHECAL USE
Max daily dose
10 mg milligram(s)
Max total dose
200 mg milligram(s)
Max treatment duration
16 Day(s)
Authorisation status
Authorised
ATC code
H02AB06 — PREDNISOLONE
Marketing authorisation
15.085
MA holder
MERCK GESELLSCHAFT MBH
MA country
Austria
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Metex 50 mg/ml injekcinis tirpalas užpildytame švirkšte

PRD10050713 · Product

Active substance
Methotrexate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
660 mg/m2 milligram(s)/sq. meter
Max total dose
3000 mg/m2 milligram(s)/sq. meter
Max treatment duration
4 Day(s)
Authorisation status
Authorised
ATC code
L04AX03 — -
Marketing authorisation
LT/1/09/1515/241
MA holder
MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country
Lithuania
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

HOLOXAN 1000 mg Pulver zur Herstellung einer Injektionslösung

PRD11964601 · Product

Active substance
Ifosfamide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
400 mg/m2 milligram(s)/sq. meter
Max total dose
4000 mg/m2 milligram(s)/sq. meter
Max treatment duration
10 Day(s)
Authorisation status
Authorised
ATC code
L01AA06 — IFOSFAMIDE
Marketing authorisation
BE117451
MA holder
BAXTER SA
MA country
Belgium
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Charite Universitaetsmedizin Berlin KöR

26 Total trials 10 Recruiting 10 Ended
Academic / Non-commercial
Sponsor organisation
Charite Universitaetsmedizin Berlin KöR
Address
Augustenburger Platz 1, Wedding Wedding
City
Berlin
Postcode
13353
Country
Germany

Scientific contact point

Organisation
Charite Universitaetsmedizin Berlin KöR
Contact name
Arend von Stackelberg

Public contact point

Organisation
Charite Universitaetsmedizin Berlin KöR
Contact name
Adriane Napp

Third parties 14

OrganisationCity, countryDuties
Ospedale Pediatrico Bambino Gesu
ORG-100009738
 Rome, Italy Other
St. Anna Childrens Cancer Research Institute GmbH
ORG-100010137
 Vienna, Austria Other
Amgen GmbH
ORG-100004004
 Munich, Germany Code 5
HUS-Yhtymae
ORG-100022862
 Helsinki, Finland Other
Karolinska University Hospital
ORG-100000573
 Solna, Sweden Other
Centre Hospitalier Universitaire De Nice
ORG-100008529
 Nice, France Other
Oslo University Hospital HF
ORG-100021349
 Oslo, Norway Other
Region Hovedstaden
ORG-100003705
 Frederiksberg, Denmark On site monitoring
Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
ORG-100041697
 Murcia, Spain Other
Prinses Maxima Centrum voor Kinderoncologie B.V.
ORG-100011005
 Utrecht, Netherlands Code 5
Fakultni Nemocnice V Motole
ORG-100012719
 Prague, Czechia Other
Pfizer Inc.
ORG-100004191
 New York, United States Code 5
Julius Clinical International B.V.
ORG-100028683
 Zeist, Netherlands Other
Rigshospitalet
ORG-100002431
 Copenhagen Oe, Denmark Other

Locations

12 EU/EEA countries · 91 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Authorised, recruitment pending 30 4
Czechia Authorised, recruitment pending 20 4
Denmark Authorised, recruitment pending 10 3
Finland Authorised, recruitment pending 10 5
France Authorised, recruitment pending 150 28
Germany Authorised, recruitment pending 250 1
Italy Authorised, recruitment pending 40 19
Netherlands Authorised, recruitment pending 25 1
Norway Authorised, recruitment pending 10 4
Réunion 0 1
Spain Authorised, recruitment pending 200 15
Sweden Authorised, recruitment pending 20 6
Rest of world
Israel, Australia, Switzerland
 — 30 —

Investigational sites

Austria

4 sites · Authorised, recruitment pending
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Universitätsklinik für Kinder- und Jugendheilkunde, Muellner Hauptstrasse 48, 5020, Salzburg
St. Anna Kinderspital GmbH
Kinderonkologie, Kinderspitalgasse 6, Alsergrund, Vienna
Medical University Of Graz
Klinische Abteilung für pädiatrische Hämato-Onkologie, Neue Stiftingtalstrasse 6, 8010, Graz
Medizinische Universitaet Innsbruck
Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation, Anichstrasse 35, 6020, Innsbruck

Czechia

4 sites · Authorised, recruitment pending
Fakultni Nemocnice Brno
Klinika dětské onkologie, Cernopolni 9, Cerna Pole, Brno
Fakultni Nemocnice V Motole
Klinika dětské hematologie a onkologie, V Uvalu 84/1, Motol, Prague
University Hospital Olomouc
Dětská klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Plzen
Dětská klinika, Alej Svobody 923/80, 323 00, Plzen 23

Denmark

3 sites · Authorised, recruitment pending
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
Region Midtjylland
Department of paediatric and adolescent medicine, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Finland

5 sites · Authorised, recruitment pending
Turku University Hospital
Paediatric and Adolescent Ward, Savitehtaankatu 1, 20520, Turku
Oulu University Hospital
Department of Pediatrics, Kajaanintie 50, 90220, Oulu
HUS-Yhtymae
Children and Adolescents, Stenbackinkatu 9, 00290, Helsinki
Kuopio University Hospital
Department of Pediatrics, Puijonlaaksontie 2, P. O. Box 1777, Kuopio
Tampere University Hospital
Department of Pediatrics, Elamanaukio 2, 33520, Tampere

France

28 sites · Authorised, recruitment pending
CHU Brest
Onco-Hématologie pédiatrique, 5 Avenue Foch, 29200, Brest
Assistance Publique Hopitaux De Paris
Pediatrie hematologie, 48 Boulevard Serurier, 75019, Paris
Assistance Publique Hopitaux De Paris
Onco-Hématologie pédiatrique, 26 Avenue Du Docteur Arnold Netter, 75012, Paris
CHU Toulouse
Onco-Hématologie pédiatrique, 330 avenue de Grande Bretagne, 31059, Toulouse
CHU Grenoble
Onco-Hématologie pédiatrique, boulevard de la chantourne, Boulevard De La Chantourne, Grenoble cedex 09
CHU Limoges
Onco-Hématologie pédiatrique, 8 avenue Dominique Larrey, 87000, Limoges
CHU de Tours - Hôpital Clocheville
Onco-Hématologie pédiatrique, 49 boulevard Béranger, 37000, Tours
Hospices Civils De Lyon
Hématologie pédiatrique, 1 Place Professeur Joseph Renaut, 69008, Lyon
Les Hopitaux Universitaires De Strasbourg
Hématologie pédiatrique, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
CHU de Montpellier
Onco-Hématologie pédiatrique, 371 avenue du doyen Gaston Giraud, 34295, Montpellier Cedex 05
Hopital Saint Louis
Hématologie pédiatrique, 1 Avenue Claude Vellefaux, 75010, Paris
Hôpital Jeanne de Flandre
Onco-hématologie, Avenue Eugène Avinée, 59037, Lille
CHU Besancon
Hématologie pédiatrique, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
CHU Dijon Bourgogne Hôpital François Mitterand
Hématologie pédiatrique, 14 rue Gaffarel, 21079, Dijon
CHU Caen Normandie
Onco-Hématologie pédiatrique, Côte de Nacre, Service de Maladies Infectieuses, Caen
CHRU Nancy - Hopitaux Brabois
Onco-Hématologie pédiatrique, Rue du Morvan, 54500, Vanoeuvre les Nancy
Centre Hospitalier Universitaire Rouen
Onco-Hématologie pédiatrique, 1 Rue De Germont, 76000, Rouen
CHU Reims – Hôpital Maison Blanche
Hématologie pédiatrique, 45 Rue Cognacq- Jay, 51092, REIMS
CHU Nantes - HME-Department onco-hematology pédiatric
Hématologie pédiatrique, 7 Quai Moncousu, 44093, Nantes
CHU Saint Etienne Hôpital Nord
Onco-Hématologie pédiatrique, Av. Albert Raimond, 42055, Saint Etienne
CHU Amiens - Groupe Hospitalier Sud
Onco-Hématologie pédiatrique, 1 1 rond-point du Professeur Cabrol, 80054, AMIENS
Centre Hospitalier Universitaire De Bordeaux
Onco-Hématologie pédiatrique, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier Universitaire De Poitiers
Onco-Hématologie pédiatrique, 2 Rue De La Miletrie, 86000, Poitiers
AP-HM- Hôpital de La Timone
Hématologie pédiatrique, 27 Boulevard Jean Moulin, 13005, Marseille
CHU Angers
Onco-Hématologie pédiatrique, 4, rue Larrey, ANGERS Cedex 09
Centre Hospitalier Universitaire De Rennes
Onco-Hématologie pédiatrique, 16 Boulevard De Bulgarie, Bp 90349, Rennes
CHU CLERMONT FERRAND - Hôpital Estaing,
Hématologie pédiatrique, 1 Place Lucie et Raymond Aubrac,, 63000, Clermont-Ferrand
Centre Hospitalier Universitaire De Nice
Onco-hématologie, 151 Route De Saint Antoine, 06200, Nice

Germany

1 site · Authorised, recruitment pending
Charite Universitaetsmedizin Berlin KöR
Paediatric Oncology and Hematology, Augustenburger Platz 1, Wedding, Berlin

Italy

19 sites · Authorised, recruitment pending
IRCCS Istituto Giannina Gaslini
Dipartimento Ematologia, Oncologia e Trapianto di Midollo, Via Gerolamo Gaslini 5, 16147, Genoa
Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
UOC di Pediatria ad indirizzo Oncoematologico, Piazzale Giulio Cesare 11, 70124, Bari
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Oncoematologia Pediatrica, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Universitaria Meyer IRCCS
Oncoematologia-Pediatrica, Viale Gaetano Pieraccini 24, 50139, Florence
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Center of pediatric Hematology Oncology, Via Santa Sofia 78, 95123, Catania
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
U.S.S. Oncoematologia Pediatrica, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliero Universitaria Delle Marche
Oncoematologia Pediatrica, Via Conca 71, 60126, Ancona
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
S.C. Oncologia Pediatrica, Piazza Polonia 94, 10126, Turin
Ospedale Pediatrico Bambino Gesu
Area Studi Clinici Oncoematologici e Terapie Cellulari, Piazza Di Sant'onofrio 4, 00165, Rome
Azienda Ospedaliera di Padova
Oncoematologia Pediatrica, Via Nicolo' Giustiniani 2, 35128, Padova
ARNAS G. Brotzu
Oncoematologia-Pediatrica, Piazzale Alessandro Ricchi 1, 09121, Cagliari
Azienda Ospedaliera Universitaria Integrata Verona
Oncoematologia-Pediatrica, Piazzale Aristide Stefani 1, 37126, Verona
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
Emato-Oncologia e Centro Trapianti, Via Dell' Istria 65/1, 34137, Trieste
Fondazione IRCCS Policlinico San Matteo
S.C. Oncoematologia Pediatrica, Viale Camillo Golgi 19, 27100, Pavia
ARNAS Civico Di Cristina Benfratelli
Oncoematologia, Piazza Nicola Leotta 4, 90127, Palermo
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Oncologia pediatrica, Via Santa Maria Di Costantinopoli 104, 80138, Naples
Azienda Ospedaliera Santobono Pausilipon
Pediatric Oncology Department, Via Posillipo 226, 80123, Naples
Fondazione IRCCS San Gerardo Dei Tintori
Clinica pediatrica, Unità di Ematologia Pediatrica Dipartimento Area della Donna e Materno Infantile, Via Giovanni Battista Pergolesi 33, 20900, Monza
Casa Sollievo Della Sofferenza
Oncoematologia Pediatrica, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo

Netherlands

1 site · Authorised, recruitment pending
Prinses Maxima Centrum voor Kinderoncologie B.V.
Hemato-oncology, Heidelberglaan 25, 3584 CS, Utrecht

Norway

4 sites · Authorised, recruitment pending
Universitetssykehuset Nord-Norge HF
Pediatric, Hansine Hansens Veg 67, 9019, Tromsoe
Oslo University Hospital HF
Pediatric Hematology and Oncology, Sognsvannsveien 20, 0372, Oslo
St. Olavs Hospital HF
Pediatric Hematology and Oncology, Prinsesse Kristinas G. 3, 7030, Trondheim
Helse Bergen HF
Children and youth clinic, Haukelandsveien 22, 5021, Bergen

Réunion

1 site ·
CHU Réunion
Onco-Hématologie pédiatrique, Allée des Topazes CS11021, 97400, Saint Denis

Spain

15 sites · Authorised, recruitment pending
Hospital Universitario De Cruces
Pediatric oncology, Cruces Plaza S/n, 48903, Barakaldo
Hospital Universitario 12 De Octubre
Pediatric oncohematology, Avenida De Cordoba Sn, 28041, Madrid
Hospital Universitario Y Politecnico La Fe
Pediatric oncohematology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitari Vall D Hebron
Pediatric oncohematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Miguel Servet
Pediatric oncohematology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Hospital Universitario La Paz
Pediatric oncohematology, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Regional De Malaga
Hematology, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital General Universitario Gregorio Maranon
Pediatric oncohematology, Calle Del Doctor Esquerdo 46, 28007, Madrid
University Hospital Virgen Del Rocio S.L.
Hematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
University Clinical Hospital Virgen De La Arrixaca
Pediatric oncology, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Hospital General Universitario Dr. Balmis
Pediatric oncology, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Sant Joan De Deu Barcelona
Oncohematology, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
University Hospital Son Espases
Pediatric oncohematology, Carretera Valldemossa 79, 07120, Palma
Complexo Hospitalario Universitario De Santiago
Oncology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Infantil Universitario Nino Jesus
Pediatric oncohematology, Avenida De Menendez Pelayo 65, 28009, Madrid

Sweden

6 sites · Authorised, recruitment pending
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Sahlgrenska Universitetssjukhuset, Barncancercentrum, Behandlingsvagen 7, Harlanda, Gothenburg
Region Vaesterbotten
Norrlands Universitetssjukhus Barn- och Ungdomskliniken Barnavdelning 3, Daniel Naezens Vag, 907 37, Umea
Region Skane Skanes Universitetssjukhus
Barncancercentrum Avd 64, Skånes Universitetssjukhus Lund, Entregatan 7, 222 42, Lund
Karolinska University Hospital
Pediatric Oncology Unit Karolinska University Hospital, Eugeniavagen 3, 171 64, Solna
Uppsala University Hospital
Akademiska barnsjukhuset, Akademiska Sjukhuset, 751 85, Uppsala
Region Oestergoetland
Universitetssjukhuset Linköping Barn- och ungdomskliniken BOND, Universitetssjukhuset I, 58185, Linkoping

Results and documents

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

Documents 149 files

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

TypeTitleVersion
Protocol (for publication) D1_Protocol_2023-509392-17-00_20260310 _redact 1.7
Protocol (for publication) D1_Protocol_2023-509392-17-00_redact 1.6
Recruitment arrangements (for publication) forfarande-for-rekrytering-och-samtyckesprocess 1.1
Recruitment arrangements (for publication) K1_ Recruitment arrangements and Informed consent procedure_IT 2.0
Recruitment arrangements (for publication) K1_Recruitment and Informed consent procedure 1
Recruitment arrangements (for publication) K1_Recruitment and Informed consent procedure DE 1
Recruitment arrangements (for publication) K1_Recruitment and Informed consent procedure ES 1
Recruitment arrangements (for publication) K1_Recruitment and Informed Consent Procedure_DK_Redacted 1.1
Recruitment arrangements (for publication) K1_Recruitment arrangement_France 0.1
Recruitment arrangements (for publication) K1_Recruitment arrangements_IntReALL BCP 2020 1.1
Recruitment arrangements (for publication) K1_Recruitment Arrangements_NL 1
Recruitment arrangements (for publication) K1_Recruitment_Arragement_CZ 1.0
Recruitment arrangements (for publication) K1_Recruitment_arrangement_NO 1
Recruitment arrangements (for publication) K2_Recruitment Material_Summary public website_REDACTED 1.0
Subject information and informed consent form (for publication) Informativa_minore_HR 1
Subject information and informed consent form (for publication) Informativa_minore_IEM 1
Subject information and informed consent form (for publication) Informativa_minore_SR 1
Subject information and informed consent form (for publication) L1 SIS and IFC_IntReALL BCP 2020_letter_parents of 15-17 y old subject 1.1
Subject information and informed consent form (for publication) L1_Bilaga Forsiktighetsatgarder for ungdomar som ar sexuellt aktiva for 15-18 ar 1
Subject information and informed consent form (for publication) L1_Bilaga Forsiktighetsatgarder for ungdomar som ar sexuellt aktiva for vardnadshavare 1
Subject information and informed consent form (for publication) L1_ICF Adults Parents Guardians FRANCE_FP 1.1
Subject information and informed consent form (for publication) L1_ICF Parents Guardians FRANCE_IntReALL BCP2020_consolidee finale_FP 1.1
Subject information and informed consent form (for publication) L1_ICF_Adult_Parents_Guardians 1
Subject information and informed consent form (for publication) L1_Information till forsoksperson 12-14 ar 1.1
Subject information and informed consent form (for publication) L1_Information till forsoksperson 15-18 ar 1.1
Subject information and informed consent form (for publication) L1_Information till forsoksperson 6-11 ar 1.1
Subject information and informed consent form (for publication) L1_Information till vardnadshavare 1.1
Subject information and informed consent form (for publication) L1_SIS Adults Patients FRANCE_FP 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF biobank HSJD 1
Subject information and informed consent form (for publication) L1_SIS and ICF biobank HULP 1
Subject information and informed consent form (for publication) L1_SIS and ICF children 13-17 years FRANCE_FP 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF children 6-12 years FRANCE_FP 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_10-13 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_12-14y 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_12-17 yr 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_14-17_redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_15-17y 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_7-9 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_adult 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Adults 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Adults_redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_biobank and accompanying research_parents_adult 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_DK_15-17 yr_Main 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_DK_15-17 yr_Randomisation 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_DK_Adult_Main 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_DK_Adult_Randomisation 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_DK_Parent_Main 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_DK_Parent_Randomisation 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_GDPR 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Guardians-Adults_redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_parents 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Parents and Guardians 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_pregnant partner 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_add-ons_DRP_parents 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_add-ons_DRP_subjects over 18y 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_Down syndrome_legal representatives 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_Down syndrome_subjects 1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_fusion gene positive_parents 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_fusion gene positive_subjects 12-14 y 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_fusion gene positive_subjects over 15y 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_fusion gene positive_subjects under 12 y 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_HR group_parents 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_HR group_subjects 12-14y 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_HR group_subjects over 15y 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_HR group_subjects under 12 y 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_IEM group_parents 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_IEM group_subjects 12-14y 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_IEM group_subjects over 15 y 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_IEM group_subjects under 12 y 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_SR group_parents 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_SR group_subjects 12-14y 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_SR group_subjects over 15 y 1.1
Subject information and informed consent form (for publication) L1_SIS and IFC_IntReALL2020_SR group_subjects under 12 y 1.1
Subject information and informed consent form (for publication) L1_SIS Parents Guardians FRANCE_IntReALLBCP2020_consolidee finale_FP 1.1
Subject information and informed consent form (for publication) L1_SIS_12-17yr 1.1
Subject information and informed consent form (for publication) L1_SIS_6-11yr 1.1
Subject information and informed consent form (for publication) L1_SIS_Adult_Patients 1.1
Subject information and informed consent form (for publication) L1_SIS_DK_10-14 yr_Main 1.1
Subject information and informed consent form (for publication) L1_SIS_DK_10-14 yr_Randomisation 1.1
Subject information and informed consent form (for publication) L1_SIS_DK_5-9 yr_Main 1.1
Subject information and informed consent form (for publication) L1_SIS_DK_5-9 yr_Randomisation 1.1
Subject information and informed consent form (for publication) L1_SIS_ICF_parents_HR_NO 2
Subject information and informed consent form (for publication) L1_SIS_ICF_parents_IEM_NO 2
Subject information and informed consent form (for publication) L1_SIS_ICF_parents_OBS_NO 2
Subject information and informed consent form (for publication) L1_SIS_ICF_parents_SR_NO 2
Subject information and informed consent form (for publication) L1_SIS_ICF_Participant_over_16yrs_HR_NO 2
Subject information and informed consent form (for publication) L1_SIS_ICF_Participant_over_16yrs_IEM_NO 2
Subject information and informed consent form (for publication) L1_SIS_ICF_Participant_over_16yrs_OBS_NO 2
Subject information and informed consent form (for publication) L1_SIS_ICF_Participant_over_16yrs_SR_NO 2
Subject information and informed consent form (for publication) L1_SIS_Parents_Guardians 1.1
Subject information and informed consent form (for publication) L1_SIS_Participant_12-16yrs_NO 2
Subject information and informed consent form (for publication) L1_SIS_participant_under_12yrs_NO 2
Subject information and informed consent form (for publication) L1_SIS-ICF_Child 12-15_High Risk_NL_REDACTED 1.1
Subject information and informed consent form (for publication) L1_SIS-ICF_Child 12-15_IEM_NL_REDACTED 1.1
Subject information and informed consent form (for publication) L1_SIS-ICF_Child 12-15_Standard Risk_NL_REDACTED 1.1
Subject information and informed consent form (for publication) L1_SIS-ICF_Child 16yr and older_High Risk_NL_REDACTED 1.1
Subject information and informed consent form (for publication) L1_SIS-ICF_Child 16yr and older_IEM_NL_REDACTED 1.1
Subject information and informed consent form (for publication) L1_SIS-ICF_Child 16yr and older_Standard Risk_NL_REDACTED 1.1
Subject information and informed consent form (for publication) L1_SIS-ICF_Parents_High Risk_NL_REDACTED 1.1
Subject information and informed consent form (for publication) L1_SIS-ICF_Parents_IEM_NL_REDACTED 1.1
Subject information and informed consent form (for publication) L1_SIS-ICF_Parents_Standard Risk_NL_REDACTED 1.1
Subject information and informed consent form (for publication) L2_ Other subject information material_Adults_Biobank_clean_redacted 1
Subject information and informed consent form (for publication) L2_ Other subject information material_Parents_Biobank_clean_redacted 1
Subject information and informed consent form (for publication) L2_ Other subject information material_Pregnancy 1
Subject information and informed consent form (for publication) L2_Identifikacni karta subjektu klinickeho hodnoceni 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_patient card 1
Subject information and informed consent form (for publication) L2_Site-specific contact details_redacted 1
Subject information and informed consent form (for publication) Lettera Medico curante_v1_02072025 1
Subject information and informed consent form (for publication) Master_centri clinici_privacy notice_ex 13_paziente adulto 1.1
Subject information and informed consent form (for publication) Master_centri clinici_privacy notice_ex 13_paziente minore 1.1
Subject information and informed consent form (for publication) Modulo_consenso_adulti_HR 1.1
Subject information and informed consent form (for publication) Modulo_consenso_adulti_IEM 1.1
Subject information and informed consent form (for publication) Modulo_consenso_adulti_SR 1.1
Subject information and informed consent form (for publication) Modulo_genitori_tutore_legale_HR 1.1
Subject information and informed consent form (for publication) Modulo_genitori_tutore_legale_IEM 1.1
Subject information and informed consent form (for publication) Modulo_genitori_tutore_legale_SR 1.1
Subject information and informed consent form (for publication) Modulo_minore_maturo_HR 1.1
Subject information and informed consent form (for publication) Modulo_minore_maturo_IEM 1.1
Subject information and informed consent form (for publication) Modulo_minore_maturo_SR 1.1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_Cyclophosphamide 1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_Cytarabine ith 1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_Cytarabine_iv 1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_Daunorubicin 1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_Dexamethasone 1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_Eldisine 1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_Etopophos 1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_Ifosfamide 1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_Mercaptopurine 1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_Methotrexate iv 1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_Methotrexate po 1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_Methotrexate_ith 1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_Mitoxantrone 1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_oncaspar-epar 1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_Solu-Dacortin 1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_Tioguanine 1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_Vincristine Sulfate 1
Summary of Product Characteristics (SmPC) (for publication) E2_SMPC_Zavedos 1
Summary of Product Characteristics (SmPC) (for publication) G1_IMPD_E-S Cross Reference Letter_InO 1
Synopsis of the protocol (for publication) D1_ Protocol synopsis_2023-509392-17-00_IT_redacted 1.2
Synopsis of the protocol (for publication) D1_IntReALL-BCP-2020_Prot Synopsis_NL_REDACTED 1.3
Synopsis of the protocol (for publication) D1_Protocol Synopsis FI 2023-509392-17-00 1.3
Synopsis of the protocol (for publication) D1_Protocol synopsis_CZ_2023-509392-17-00 1.3
Synopsis of the protocol (for publication) D1_Protocol synopsis_ES_2023-509392-17-00 1.3
Synopsis of the protocol (for publication) D1_Protocol synopsis_SE_2023-509392-17-00 1.2
Synopsis of the protocol (for publication) D1_Protocol_synopsis French_2023-509392-17-00_FP 1.3
Synopsis of the protocol (for publication) D1_Protocol_Synopsis_AT_2023-509392-17-00_redact 1.7
Synopsis of the protocol (for publication) D1_Protocol_Synopsis_DE_2023-509392-17-00_redact 1.7
Synopsis of the protocol (for publication) D1_Protocol_Synopsis_DE_en_2023-509392-17-00_redact 1.7
Synopsis of the protocol (for publication) D1_Protocol_synopsis_MS_2023-509392-17-00_NO 1.2

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-08-22 Germany Acceptable with conditions
2025-12-08
 2025-12-09
2 SUBSTANTIAL MODIFICATION SM-1 2025-12-17 Germany Acceptable
2026-04-07
 2026-04-07

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