Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
5,100
Countries
5
Sites
99
acute lymphoblastic leukemia in children and adolescents
- Randomization R-eHR: Early high-risk (early HR) pB-ALL defined by genetics and/or inadequate treatment response over the course of induction: Can the pEFS from time of randomization be improved by additional therapy with the proteasome inhibitor Bortezomib during an extended consolidation treatment phase compared to …
Key facts
- Sponsor
- Universitaetsklinikum Schleswig-Holstein
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 15 Jul 2018 → ongoing
- Decision date (initial)
- 2024-07-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509856-32-00
- EudraCT number
- 2016-001935-12
- ClinicalTrials.gov
- NCT03643276
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Therapy, Efficacy, Safety
- Randomization R-eHR: Early high-risk (early HR) pB-ALL defined by genetics and/or inadequate treatment response over the course of induction: Can the pEFS from time of randomization be improved by additional therapy with the proteasome inhibitor Bortezomib during an extended consolidation treatment phase compared to standard extended consolidation?
- Randomization R-HR: High-risk (HR) pB-ALL defined by genetics and/or inadequate treatment response by the end of consolidation: Can the pEFS from time of randomization be improved by a treatment concept including two cycles of post-consolidation immunotherapy with Blinatumomab (15 μg/m²/d for 28 days per cycle) plus 4 doses intrathecal Methotrexate compared to two conventional highly intensive chemotherapy courses?
- Randomization R-MR: Intermediate risk (MR) pB-ALL defined by genetics and intermediate MRD response: Can the probability of disease free survival (pDFS) from time of randomization be improved by additional therapy with one cycle of post-reintensification immunotherapy with Blinatomomab (15 μg/m²/d for 28 days)?
- Randomization R-T: Early non-standard risk (early non-SR) T-ALL patients defined by treatment response over the course of induction: Can the pEFS from time of randomization be improved by the extension of the standard of care consolidation phase by 14 days with an increase of the consolidation cumulative doses of Cyclophosphamide, Cytarabine and 6-Mercaptopurine by 50%?
Secondary objectives 8
- All randomizations: Can the overall survival be improved by the treatment in the experimental arm?
- All randomizations: What is the incidence of treatment-related toxicities and mortality in the experimental arm compared to the standard arm?
- Randomization R-eHR: Can the MRD load after consolidation treatment XML File Identifier: 51lGTttgSB0vyn8HS7SCIf4qg1c= Page 93/121 be reduced by the additional treatment with Bortezomib?
- Randomization R-HR: Can treatment-related life-threatening complications and mortality during the intensified consolidation phase of high-risk treatment be reduced when replacing two intensive chemotherapy courses by two cycles of immunotherapy with Blinatumomab?
- Randomization R-HR: What is the proportion of patients with insufficient MRD response to Blinatumomab as defined in the protocol (section 3.1.7) as compared to the MRD response after the HR-2' block in the control arm?
- Randomization R-HR: Can the MRD load after the first treatment cycle (HR-2'/Blinatumomab) and the second cycle (HR-3'/Blinatumomab) be reduced in the experimental arm when compared with conventional intensive chemotherapy?
- Randomization R-MR: What is the proportion of patients with positive MRD after reintensification Protocol II who become MRD-negative over the Blina cycle compared to 4 weeks of standard maintenance therapy? - Randomization R-T: Can the MRD load after consolidation treatment be reduced by extension of the consolidation phase?
- Standard-risk patients: Is the clinical outcome comparable to that obtained for standard-risk patients in study AIEOP-BFM ALL 2009?
Conditions and MedDRA coding
acute lymphoblastic leukemia in children and adolescents
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10000844 | Acute lymphoblastic leukaemia | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- newly diagnosed acute lymphoblastic leukemia, from 1st September 2023 onwards only acute lymphoblastic leukemia with T-cell phenotype or
- newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria: • biphenotypic with a dominant T or B lineage assignment,from 1st September 2023 onwards only those with a dominant T lineage assignment, •bilineal either with a dominant lymphoblastic (from 1st September 2023 onwards only T lymphoblastic) population or if another reasonable rationale exists to treat the patient with an ALL-based therapy regimen
- newly diagnosed acute undifferentiated leukemia
- age < 18 years (up to 17 years and 365 days) at the day of diagnosis
- patient enrolled in a participating center
- written informed consent to trial participation and transfer and processing of data
Exclusion criteria 11
- Ph+ (BCR-ABL1 or t(9;22)-positive) ALL
- bilineal leukemia with a lymphoblastic and a separate nonlymphoblastic (≥ 10% of total cells) blast subset
- pre-treatment with cytostatic drugs
- glucocorticoid pre-treatment with ≥ 1 mg/kg/d Prednisolone equivalent for more than two weeks during the last month before diagnosis
- treatment started according to another protocol
- underlying diseases that does not allow treatment according to the protocol
- ALL diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy
- evidence of pregnancy or lactation period
- Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of antileukemic therapy
- participation in another clinical trial that interferes with the protocol
- other condition (either pre-existing or related to leukemia biology as present at diagnosis) or circumstances that significantly conflict with the treatment according to the protocol
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- For the randomized study questions, the primary endpoint will be the time from randomization until the first event defined as follows: Randomization R-eHR, R-HR and R-T: Cytomorphological or molecular non-response (resistance to protocol treatment, considered as event at day zero), relapse, second malignancy or death from any cause. This will be called EFS time.
- Randomization R-MR: Relapse, second malignancy or death from any cause. This will be called DFS time.
- EFS and DFS time: end of study
Secondary endpoints 6
- Survival starting at the same time point as the EFS/DFS
- Frequency and incidence of treatment-related mortality in induction or CCR
- Frequency and incidence of AE of interest and SAE in specific protocol phases, randomized arms and overall during follow-up
- MRD load after the randomized treatment phases (R-eHR, R-HR, R-MR and R-T)
- MRD load after the first/second cycle of Blinatumomab or after the HR 2'/HR 3' block (R-HR)
- Proportion of patients with poor MRD response to the first Blinatumomab cycle ("Blinatumomab Poor-Response") (R HR)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 22
SCP13241261 · ATC
- Active substance
- Bortezomib
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1.3 mg/m2 milligram(s)/square meter
- Max total dose
- 5.2 mg/m2 milligram(s)/square meter
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XG01 — BORTEZOMIB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP15642072 · ATC
- Route of administration
- ORAL
- Max daily dose
- 60 mg/m2 milligram(s)/square meter
- Max total dose
- 840 mg/m2 milligram(s)/square meter
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB03 — TIOGUANINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Oncaspar 750 U/ml powder for solution for injection/infusion.
PRD6822247 · Product
- Active substance
- Pegaspargase
- Substance synonyms
- PEG-Asparaginase, PEG-L-Asparaginase
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 3750 IU international unit(s)
- Max total dose
- 33750 IU international unit(s)
- Max treatment duration
- 40 Week(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
—
SCP10332310 · ATC
- Route of administration
- ORAL AND IV
- Max daily dose
- 20 mg/m2 milligram(s)/square meter
- Max total dose
- 1035 mg/m2 milligram(s)/square meter
- Max treatment duration
- 42 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP10339494 · ATC
- Active substance
- Methotrexate Sodium
- Substance synonyms
- SODIUM METHOTREXATE, MTX SODIUM
- Route of administration
- ORAL AND IV
- Max daily dose
- 5000 mg/m2 milligram(s)/square meter
- Max total dose
- 23000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 21 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA01 — METHOTREXATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP10339494 · ATC
- Active substance
- Methotrexate Sodium
- Substance synonyms
- SODIUM METHOTREXATE, MTX SODIUM
- Route of administration
- INTRATHECAL
- Max daily dose
- 12 mg milligram(s)
- Max total dose
- 312 mg milligram(s)
- Max treatment duration
- 66 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BA01 — METHOTREXATE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP11397391 · ATC
- Route of administration
- INTRAVENOUS
- Max daily dose
- 30 mg/m2 milligram(s)/square meter
- Max total dose
- 150 mg/m2 milligram(s)/square meter
- Max treatment duration
- 14 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01DB02 — DAUNORUBICIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1137788 · ATC
- Active substance
- Vinorelbine
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 28 mg milligram(s)
- Max treatment duration
- 44 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CA02 — VINCRISTINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13772MIG · Substance
- Active substance
- Etoposide Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 500 mg/m2 milligram(s)/square 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
SCP131338 · ATC
- Active substance
- Prednisolone
- Substance synonyms
- (8S,9S,10S,11S,13S,14S,17R)-11,17-DIHYDROXY-17-(2-HYDROXYACETYL)-10,13-DIMETHYL-7,8,9,11,12,14,15,16-OCTAHYDRO-6H-CYCLOPENTA[A]PHENANTHREN-3-ONE, GLPG0303, DELTA-HYDROCORTISONE, 1,2-DEHYDROHYDROCORTISONE, METACORTANDRALONE
- Route of administration
- ORAL
- Max daily dose
- 60 mg/m2 milligram(s)/square meter
- Max total dose
- 1837.5 mg/m2 milligram(s)/square meter
- Max treatment duration
- 37 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB07 — PREDNISONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP1158234 · ATC
- Route of administration
- ORAL AND IV
- Max daily dose
- 60 mg/m2 milligram(s)/square meter
- Max total dose
- 1837.5 mg/m2 milligram(s)/square meter
- Max treatment duration
- 37 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP100376572 · ATC
- Active substance
- Etoposide
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01CB01 — ETOPOSIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP13827298 · ATC
- Active substance
- Mercaptopurine
- Substance synonyms
- MERCAPTOPURINE ANHYDROUS, 3,7-DIHYDROPURINE-6-THIONE, 6-MERCAPTOPURINE, 6MP
- Route of administration
- ORAL
- Max daily dose
- 100 mg/m2 milligram(s)/square meter
- Max total dose
- 54320 mg/m2 milligram(s)/square meter
- Max treatment duration
- 23 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BB02 — MERCAPTOPURINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Erwinase, 10,000 IU/vial, Powder for solution for injection/infusion.
PRD9950456 · Product
- Active substance
- Crisantaspase
- Substance synonyms
- ERWINASE, ERWINIA L-ASPARAGINASE
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION OR INTRAMUSCULAR INJECTION
- Max daily dose
- 20000 IU international unit(s)
- Max total dose
- 1260000 IU international unit(s)
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XX02 — ASPARAGINASE
- Marketing authorisation
- PL 44403/0002
- MA holder
- PORTON BIOPHARMA LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP142361 · ATC
- Active substance
- Cytarabine
- Substance synonyms
- ARA-C, CYTOSINE ARABINOSIDE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2000 mg/m2 milligram(s)/square meter
- Max total dose
- 15600 mg/m2 milligram(s)/square meter
- Max treatment duration
- 39 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC01 — CYTARABINE
- 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
- Max daily dose
- 28 µg microgram(s)
- Max total dose
- 1568 µg microgram(s)
- Max treatment duration
- 56 Day(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
- Yes
- Orphan designation number
- EU/3/09/650
- Modified vs. Marketing Authorisation
- No
SCP14962750 · ATC
- Active substance
- Vindesine Sulfate
- Substance synonyms
- VINDESINE SULPHATE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01CA03 — VINDESINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP138158 · ATC
- Active substance
- Doxorubicin Hydrochloride
- Route of administration
- INTRAVENOUS
- Max daily dose
- 30 mg/m2 milligram(s)/square meter
- Max total dose
- 124 mg/m2 milligram(s)/square meter
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01DB01 — DOXORUBICIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP11431448 · ATC
- Active substance
- Ifosfamide
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1600 mg/m2 milligram(s)/square meter
- Max total dose
- 4000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA06 — IFOSFAMIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Myocet 50 mg powder, dispersion and solvent for concentrate for dispersion for infusion
PRD4171236 · Product
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 50 mg/m2 milligram(s)/square meter
- Max total dose
- 250 mg/m2 milligram(s)/square meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01DB01 — DOXORUBICIN
- Marketing authorisation
- EU/1/00/141/002
- MA holder
- TEVA B.V
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP107125968 · ATC
- Route of administration
- INTRAVENOUS
- Max daily dose
- 30 mg/m2 milligram(s)/square meter
- Max total dose
- 150 mg/m2 milligram(s)/square meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP106382672 · ATC
- Active substance
- Cyclophosphamide
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1000 mg/m2 milligram(s)/square meter
- Max total dose
- 6500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 41 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Schleswig-Holstein
- Sponsor organisation
- Universitaetsklinikum Schleswig-Holstein
- Address
- Arnold-Heller-Strasse 3, Brunswik Brunswik
- City
- Kiel
- Postcode
- 24105
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Schleswig-Holstein
- Contact name
- Prof. Dr. med. Martin Schrappe
Public contact point
- Organisation
- Universitaetsklinikum Schleswig-Holstein
- Contact name
- Prof. Dr. med. Martin Schrappe
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Medizinische Hochschule Hannover ORG-100024473
|
Hanover, Germany | Code 10 |
| Universita Degli Studi Di Milano Bicocca ORG-100010580
|
Monza, Italy | Code 10 |
| Fondazione IRCCS San Gerardo Dei Tintori ORG-100043263
|
Monza, Italy | On site monitoring, Code 12, Code 13, Code 5, Data management |
| Medizinische Hochschule Hannover ORG-100024473
|
Hanover, Germany | Data management, E-data capture |
| St. Anna Kinderspital GmbH ORG-100023908
|
Vienna, Austria | Code 12, Code 13, Code 5, Data management, Code 8 |
| St. Anna Childrens Cancer Research Institute GmbH ORG-100010137
|
Vienna, Austria | On site monitoring |
| Fakultni Nemocnice V Motole ORG-100012719
|
Prague, Czechia | On site monitoring, Code 12, Code 13, Code 5, Data management, Code 8 |
| Narodny Ustav Detskych Chorob ORG-100046512
|
Bratislava, Slovakia | On site monitoring, Code 12, Code 13, Code 5, Data management |
Locations
5 EU/EEA countries · 99 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 250 | 5 |
| Czechia | Ongoing, recruitment ended | 300 | 8 |
| Germany | Ongoing, recruitment ended | 1,850 | 51 |
| Italy | Ongoing, recruitment ended | 1,700 | 32 |
| Slovakia | Ongoing, recruitment ended | 150 | 3 |
| Rest of world
Australia, Switzerland, Israel
|
— | 850 | — |
Investigational sites
Kepler Universitaetsklinikum GmbH
Med Campus IV/Onkologie, Krankenhausstrasse 7a, 4020, Linz
St. Anna Kinderspital GmbH
Onkologie, Kinderspitalgasse 6, Alsergrund, Vienna
Medizinische Universitaet Innsbruck
Pädiatrie I, Anichstrasse 35, 6020, Innsbruck
Medical University Of Graz
Klinische Abteilung für pädiatrische Hämato-Onkologie, Neue Stiftingtalstrasse 6, 8010, Graz
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Kinderonkologie, Muellner Hauptstrasse 48, 5020, Salzburg
Krajska zdravotni a.s.
Department of Pediatrics, Socialni Pece 3316/12a, Severni Terasa, Usti Nad Labem
Fakultni Nemocnice Brno
Department of Pediatric Oncology, Cernopolni 9, Cerna Pole, Brno-Sever
Nemocnice Ceske Budejovice a.s.
Department of Pediatrics, B. Nemcove 585/54, 370 01, Ceske Budejovice
Fakultni Nemocnice Ostrava
Department of Pediatrics, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice V Motole
Department of Pediatric Hematology and Oncology, V Uvalu 84/1, Motol, Prague
Fakultni Nemocnice Hradec Kralove
Department of Pediatrics, Sokolska 581, 500 03, Novy Hradec Kralove
University Hospital Olomouc
Department of Pediatrics, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Plzen
Department of Pediatrics, Alej Svobody 923/80, 323 00, Plzen 23
Klinikum Dortmund gGmbH
Klinik für Kinder- und Jugendmedizin, Beurhausstrasse 40, Mitte, Dortmund
Asklepios Klinik Sankt Augustin GmbH
Klinik für Kinder und Jugendmedizin, Arnold-Janssen-Strasse 29, 53757, Sankt Augustin
Staedtisches Klinikum Braunschweig gGmbH
Zentrum für Kinder- und Jugendmedizin, Salzdahlumer Strasse 90, Suedstadt, Brunswick
Universitaetsklinikum Augsburg
Schwäbisches Kinderkrebszentrum Kinderkrebsforschungszentrum, Stenglinstrasse 2, Kriegshaber, Augsburg
Otto Von Guericke Universitaet Magdeburg
Klinik für Kinder- und Jugendmedizin, pädiatrische Hämatologie und Onkologie, Leipziger Strasse 44, Leipziger Str., Magdeburg
Staedtisches Klinikum Karlsruhe gGmbH
Pädiatrische Onkologie und Hämatologie, Moltkestrasse 90, Weststadt, Karlsruhe
Charite Universitaetsmedizin Berlin KöR
Klinik f. Pädiatrie m. S. Onkolgie/Hämatologie, Augustenburger Platz 1, Wedding, Berlin
Universitaetsklinikum Heidelberg AöR
Hopp-Kindertumorzentrum Heidelberg (KiTZ), Im Neuenheimer Feld 430, Neuenheim, Heidelberg
Universitaetsklinikum Tuebingen AöR
Abteilung Kinderheilkunde I mit Poliklinik, Hoppe-Seyler-Strasse 1, Nordstadt, Tuebingen
University Hospital Cologne AöR
Klinik und Poliklinik für Kinder- und Jugendmedizin, Kerpener Strasse 62, Lindenthal, Cologne
Universitaetsklinikum Ulm AöR
Klinik für Kinder-und Jugendmedizin , Pädiatrische Hämatologie und Onkologie,, Eythstrasse 24, Mitte, Ulm
Klinikum rechts der Isar der TU Muenchen AöR
Kinderklinik München Schwabing, Koelner Platz 1, Schwabing-West, Munich
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Kinder und Jugendmedizin, Arnold-Heller-Strasse 3, Brunswik, Kiel
Universitaetsklinikum Erlangen AöR
Kinder- und Jugendklinik, Päd. Hämatologie und Onkologie, Loschgestrasse 15, Innenstadt, Erlangen
HELIOS Kliniken Schwerin GmbH
Klinik für Kinder und Jugendmedizin, Wismarsche Strasse 393-397, 19049, Schwerin
Universitaetsklinikum Regensburg AöR
Kinderklinik, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Goethe University Frankfurt
Klinik für Kinder und Jugendmedizin, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Essen AöR
Zentrum für Kinder- und Jugendmedizin, Hufelandstrasse 55, Holsterhausen, Essen
Private Universitaet Witten/Herdecke gGmbH
Pädiatrische Onkologie und Hämatologie, Alfred-Herrhausen-Strasse 50, 58448, Witten
Kliniken der Stadt Koeln gGmbH
Kinderkrankenhaus, Amsterdamer Strasse 59, Riehl, Cologne
Universitaet Leipzig
Department für Frauen- und Kindermedizin, selbst. Abt. für Päd. Onkol., Hämatol. und Hämostaseol., Liebigstrasse 22, Zentrum-Suedost, Leipzig
Universitaetsklinikum Aachen AöR
Sektion Pädiatrische Hämatologie, Onkologie u. Stammzelltransplantation, Pauwelsstrasse 30, 52074, Aachen
Universitaetsklinikum Duesseldorf AöR
Klinik für Kinder- Onkologie, Moorenstrasse 5, Bilk, Duesseldorf
Universitaetsklinikum Jena KöR
Pädiatrische Hämatologie und Onkologie, Am Klinikum 1, Lobeda, Jena
Universitaetsmedizin Goettingen
Abt. Pädiatrische Hämatologie und Onkologie, Robert-Koch-Strasse 40, Weende, Goettingen
Klinikum Oldenburg AöR
Pädiatrische Onkologie und Hämatologie, Rahel-Straus-Strasse 10, Kreyenbrueck, Oldenburg
Klinikum der Universitaet Muenchen AöR
Klinik für Kinder und Jugendmedizin, Lindwurmstrasse 4, Ludwigsvorstadt-Isarvorstadt, Munich
Medical Center - University Of Freiburg
Klinik für Kinder und Jugendmedizin, Breisacher Strasse 62, Stuehlinger, Freiburg Im Breisgau
Rostock University Medical Center
Pädiatrische Onkologie und Hämatologie, Schillingallee 35, Hansaviertel, Rostock
Gemeinschaftsklinikum Mittelrhein gGmbH
Klinik für Kinder und Jugendmedizin, Koblenzer Str 115-155, 56073, Koblenz
Medizinische Hochschule Hannover
Zentrum Kinderheilkunde und Jugendmedizin, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
HELIOS Klinikum Erfurt GmbH
Kinderonkologisches Zentrum, Klinik für Kinder- und Jugendmedizin, Nordhaeuser Strasse 74, Andreasvorstadt, Erfurt
Muehlenkreiskliniken AöR
Universitätsklinik für Kinder- und Jugendmedizin, Hans-Nolte-Strasse 1, Haeverstaedt, Minden
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Zentrum für Kinder-, Jugend- und Frauenmedizin, Kriegsbergstrasse 62, Mitte, Stuttgart
Universitaetsklinikum Wuerzburg AöR
Kinderklinik - Onkologische Tagesklinik, Josef-Schneider-Strasse 2, Grombuehl, Wuerzburg
Klinikum Kassel GmbH
Kinderklinik f. päd. Hämato-Onkologie, Psychosomatik und Systemerkrankungen, Moenchebergstrasse 41-43, Fasanenhof, Kassel
Technische Universitaet Dresden
Klinik und Poliklinik für Kinder- und Jugendmedizin, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Martin-Luther-Universitaet Halle-Wittenberg
Pädiatrie I, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Kinder- und Jugendmedizin Hämatologie und Onkologie, Ratzeburger Allee 160, 23538, Luebeck
Klinik Hallerwiese - Cnopfsche Kinderklinik
Pädiatrische Onkologie und Hämatologie, St Johannis Muehlgasse 19, 90419, Nuernberg
Universitaet Muenster
Klinik für Kinder- und Jugendmedizin, pädiatrische Hämatologie und Onkologie, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Universitaet Des Saarlandes
Pädiatrische Onkologie und Hämatologie, Kirrberger Strasse 100, 66421, Homburg
Klinikum Wolfsburg
Pädiatrische Onkologie und Hämatologie, Sauerbruchstrasse 7, Klieversberg, Wolfsburg
Justus-Liebig-Universitaet Giessen
Zentrum für Kinderheilkunde und Jugendmedizin,Abt. Pädiatrische Hämatologie / Onkologie, Feulgenstrasse 10-12, 35392, Giessen
Universitaetsmedizin Greifswald KöR
Pädiatrische Onkologie und Hämatologie, Ferdinand-Sauerbruch-Strasse, 17489, Greifswald
Klinikum Chemnitz gGmbH
Klinik für Kinder- und Jugendmedizin, Flemmingstrasse 2, Altendorf, Chemnitz
HELIOS Klinikum Berlin-Buch GmbH
Klinik für Kinder- und Jugendmedizin, Schwanebecker Chaussee 50, Buch, Berlin
Gemeinschaftskrankenhaus Herdecke gGmbH
Pädiatrische Onkologie und Hämatologie, Gerhard-Kienle-Weg 4, Westende, Herdecke
SLK-Kliniken Heilbronn GmbH
Kinder- und Jugendmedizin mit Perinatalzentrum, Am Gesundbrunnen 20-26, Neckargartach, Heilbronn
Universitaetsklinikum Mannheim GmbH
Klinik für Kinder- und Jugendmedizin, pädiatrische Hämatologie und Onkologie, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Carl-Thiem-Klinikum Cottbus gGmbH
Pädiatrische Onkologie und Hämatologie, Thiemstrasse 111, Spremberger Vorstadt, Cottbus
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
S.C. oncoematologia pediatrica e TMO, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedale-Universita Padova
UOC Oncoematologia Pediatrica, Via Nicolo' Giustiniani 2, 35128, Padova
Casa Sollievo Della Sofferenza
U.O.C di Oncoematologia Pediatrica, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Azienda Ospedaliera Universitaria Integrata Verona
UOC Oncoematologia Pediatrica, Piazzale Aristide Stefani 1, 37126, Verona
Azienda Ospedaliera Universitaria Meyer IRCCS
SOC Oncologia, Ematologia, TCSE e Terapia Genica, Viale Gaetano Pieraccini 24, 50139, Florence
Azienda Sanitaria Locale Di Taranto
Oncoematologia Pediatrica, Via Bruno, 72100, Taranto
L’Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon
DIP.DI ONCOLOGIA, EMATOLOGIA E TERAPIE CELLULARI, Via Posillipo 226, 80123, Naples
Azienda Unita Sanitaria Locale Della Romagna
U.O. Pediatria, Viale Luigi Settembrini 2, 47923, Rimini
Azienda Ospedaliero Universitaria Pisana
UO Oncoematologia Pediatrica, Via Roma 67, 56126, Pisa
Azienda Ospedaliera Universitaria Mater Domini
S.O.C. ematologia e oncologia pediatrica, Viale Pio X 95, 88100, Catanzaro
European Hematology Association
Dipartimento di Medicina Traslazionale e di Precisione, Via Benevento 6, 00161, Rome
Giannina Gaslini Institute For Scientific Hospitalization And Care
U.O.C. ONCOLOGIA - Dipartimento Emato-Oncologia, Via Gerolamo Gaslini 5, 16147, Genoa
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
UOSD Oncoematologia Pediatrica, Viale Europa, 89133, Reggio Calabria
ARNAS G. Brotzu
S.C. Oncoematologia pediatrica, Piazzale Alessandro Ricchi 1, 09121, Cagliari
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Center of Pediatric Hematology Oncology, Via Santa Sofia 78, 95123, Catania
Ospedale Pediatrico Bambino Gesu'
Area Studi Clinici Oncoematologici e Terapie Cellulari, Piazza Sant'onofrio 4, 00165, Rome
Seconda Universita Di Napoli
U.P. "Terapie innovative in Oncologia Pediatrica", Vico Luigi De Crecchio 7, 80138, Naples
Azienda Ospedaliero Universitaria Parma
UOC Pediatria e Oncoematologia, Viale Antonio Gramsci 14, 43126, Parma
University Hospital Consorziale Policlinico
U.O.C 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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
U.O. oncologia pediatrica, Largo Agostino Gemelli 8, 00168, Rome
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
UOS Oncologia Pediatrica, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
DIPARTIMENTO PATOLOGIA E CURA DEL BAMBINO-SC Oncoematologia Pediatrica, Piazza Polonia 94, 10126, Turin
Hospital Santa Maria Della Misericordia
S.C. Oncoematologia pediatrica con TCSE, Piazzale Giorgio Menghini 1, 06129, Perugia
Azienda Ospedaliero Universitaria Delle Marche
Oncoematologia pediatrica, Via Conca 71, 60126, Ancona
Fondazione IRCCS San Gerardo Dei Tintori
SC Pediatria, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Ospedaliero Universitaria Di Modena
U.O. Oncoematologia pediatrica, Largo Del Pozzo 71, 41124, Modena
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo
SC Oncoematologia Pediatrica, Via Dell' Istria 65/1, 34137, Trieste
Azienda Sanitaria Locale Di Pescara
UO di Oncoematologia Pediatrica, Via Renato Paolini 47, 65124, Pescara
Ospedale Vito Fazzi Lecce
UOC Oncoematologia Pediatrica, Piazza Filippo Muratore 1, 73100, Lecce
ARNAS Civico Di Cristina Benfratelli
U.O.C. Oncoematologia pediatrica, Piazza Nicola Leotta 4, 90127, Palermo
Fondazione IRCCS Policlinico San Matteo
S.C. Ematologia 2 - Oncoematologia Pediatrica, Viale Camillo Golgi 19, 27100, Pavia
Narodny Ustav Detskych Chorob
Klinika detskej hematologie a onkologie, Limbova 1, 833 40, Bratislava
Detska Fakultna Nemocnica S Poliklinikou Banska Bystrica
Detska fakultná nemocnica s Poliklinikou, Namestie Ludvika Svobodu 4, 974 01, Banska Bystrica
Detska Fakultna Nemocnica Kosice
Detska fakultna nemocnica Košice, Trieda Snp 1, Zapad, Kosice
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2018-10-12 | 2018-10-13 | 2024-03-31 | ||
| Czechia | 2019-04-18 | 2019-04-18 | 2024-03-31 | ||
| Germany | 2018-07-15 | 2018-07-16 | 2024-03-31 | ||
| Italy | 2019-03-01 | 2019-03-14 | 2024-03-31 | ||
| Slovakia | 2019-05-21 | 2019-05-21 | 2024-03-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 125 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-509856_32-_Appendice nazionale IT_redacted | 1.0 |
| Protocol (for publication) | D1_Protocol_2023-509856_32-_redacted_ | 6.0 |
| Recruitment arrangements (for publication) | AIEOP-BFM ALL 2017_Blank_document_Transition | 1 |
| Recruitment arrangements (for publication) | AIEOP-BFM ALL 2017_Blank_document_Transition | 1 |
| Recruitment arrangements (for publication) | AIEOP-BFM ALL 2017_Blank_document_Transition | 1 |
| Recruitment arrangements (for publication) | AIEOP-BFM ALL 2017_Blank_document_Transition | 1 |
| Recruitment arrangements (for publication) | AIEOP-BFM ALL 2017_Blank_document_Transition | 1 |
| Subject information and informed consent form (for publication) | AIEOP-BFM 2017_SIS_ICF_Germany_Begleitforschung_12-15y | 1.0 |
| Subject information and informed consent form (for publication) | AIEOP-BFM 2017_SIS_ICF_Germany_Begleitforschung_8-11y | 1.0 |
| Subject information and informed consent form (for publication) | AIEOP-BFM 2017_SIS_ICF_Germany_Begleitforschung_over 18y_redacted | 1.0 |
| Subject information and informed consent form (for publication) | AIEOP-BFM 2017_SIS_ICF_Germany_Begleitforschung_over16y_redacted | 1.0 |
| Subject information and informed consent form (for publication) | AIEOP-BFM 2017_SIS_ICF_Germany_Begleitforschung_parents_redacted | 1.0 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_12-15yrs_main | 2 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_12-15yrs_R-eHR | 1.0 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_12-15yrs_R-HR | 1.0 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_12-15yrs_R-MR | 1.0 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_12-15yrs_R-T | 1.0 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_16-17yrs_main | 3 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_16-17yrs_R-eHR | 1 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_16-17yrs_R-HR | 2 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_16-17yrs_R-MR | 2 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_16-17yrs_R-T | 1 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_18 or greater_ancillary study | 1.1 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_18 or greater_main | 4 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_18 or greater_privacy_redacted | 2 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_18 or greater_R-eHR | 1.1 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_18 or greater_R-HR | 2 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_18 or greater_R-MR | 2 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_18 or greater_R-T | 1.1 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_8-11yrs_main | 1.0 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_8-11yrs_R-eHR | 1.0 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_8-11yrs_R-HR | 1.0 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_8-11yrs_R-MR | 1.0 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_8-11yrs_R-T | 1.0 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_8yrs or lower_main | 1.0 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_parents_ancillary study | 1.1 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_parents_HR-Down | 1 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_parents_main | 4 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_parents_privacy_redacted | 2 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_parents_R-eHR | 1.1 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_parents_R-HR | 2 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_parents_R-MR | 2 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS and ICF_Italy_parents_R-T | 1.1 |
| Subject information and informed consent form (for publication) | AIEOP-BFM ALL 2017_SIS_ICF_Germany_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_ Info_Storage Transfer_PersData_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_CF_Blinatumomab_DS_HR_Parents and over 18 yr | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_CF_Rand_R-MR_parents and over 18 yr | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_CF_Rand_R-T_Parents and over 18 yr | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_CF_Storage Transfer Pers_Data_Parents | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_CFRand_R-eHR_Parents and over 18yr | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_CFRand_R-HR_Parents and over 18 yr | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_CFStorage Transfer PersData_over 18 yr | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_Consent Form_Parents_Subject over 18 yr | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_Info_Blinatumomab_DS_HR-pB-ALL_Parents | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_Info_CNS radiotherapy | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_Info_Pregnancy_Store_Transf_PersData _Partner_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_Info_Protocol_Changes_Parents and over 18 yr_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_Info_Rand_R-eHR_over 18 yr | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_Info_Rand_R-eHR_Parents | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_Info_Rand_R-HR_over 18 yr | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_Info_Rand_R-HR_Parents | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_Info_Rand_R-MR_over 18 yr | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_Info_Rand_R-MR_Parents | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_Info_Rand_R-T_over 18 yr | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_Info_Rand_R-T_Parents | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_InfoTPMT_ Testing_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_Parents or the Legal Representative_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_Record on Initial Interview | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS and ICF_SK_Subject over 18 yr_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_12-15 yr_Randomisierung R-eHR | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_12-15 yr_Randomisierung R-HR | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_12-15 yr_Randomisierung R-MR | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_12-15 yr_Randomisierung R-T | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_12-15 yr_Therapie-Forschung-Datenverwendung_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_8-11 yr_ Randomisierung R-eHR | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_8-11 yr_Randomisierung R-HR | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_8-11 yr_Randomisierung R-MR | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_8-11 yr_Randomisierung R-T | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_8-11 yr_Therapie-Forschung-Datenverwendung | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_Adolescents_ Schadelbestrahlung | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_Adolescents_Randomisierung R-eHR | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_Adolescents_Randomisierung R-HR | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_Adolescents_Randomisierung R-MR | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_Adolescents_Randomisierung R-T | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_Adolescents_Therapie-Forschung-Datenverwendung_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_Adults_ Re-Consent nach erreichen der Volljahrigkeit | 1.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_Aufklarungsgesprach | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_Contacts_redacted | 20230217 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_Parents_ Randomisierung R-eHR | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_Parents_Blinatumomab Patienten mit Down-Syndrom | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_Parents_Randomisierung R-HR | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_Parents_Randomisierung R-MR | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_Parents_Randomisierung R-T | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_Parents_Schadelbestrahlung | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_Parents_Therapie-Forschung-Datenverwendung_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_simplyfied version_Blinatumomab Patienten mit Down-Syndrom | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_AT_Younger children_Therapie-Forschung-Datenverwendung | 3.0 |
| Subject information and informed consent form (for publication) | L1_AIEOP-BFM ALL 2017_SIS_ICF_CZ_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1-AIEOP-BFM ALL 2017_SIS_ICF_AT_ Schwangerschaft_redacted | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Bortezomib MSN_03-23 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cyclophosphamide_Sandoz_04-21 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cytarabine Pfizer_04-22 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Daunoblastin_Pfizer_9-19 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dexamethason Hospira | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dexamethasone Tablets Aspire_03-22 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Doxorubicin Medac | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Erwinase Porton Biopharma_07-22 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Etoposid medac | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Etoposidphosphat Neon | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fludarabine Genzyme_Sanofi | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ifosfamide Baxter_04-22 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Mercaptopurine Aspen Pharma_02-23 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Methotrexate for Infusion medac | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Methotrexate Tablets Cipla | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Myocet Teva_04-15 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Oncaspar_Servier | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Prednisolone for Injection Merck_11-19 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Prednisolone Tablets Accord_05-21 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Prednisone Merck_09-17 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Tioguanine Aspen | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vincristine Hospira | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vindesine GenusPharm_11-18 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT 2023-509856-32-redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-509856-32_SK_redacted | 4.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_AT_2023-509856-32-00_redacted | 4.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-30 | Germany | Acceptable 2024-07-04
|
2024-07-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-25 | Germany | Acceptable 2025-02-28
|
2025-02-28 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-18 | Germany | Acceptable | 2025-03-20 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-20 | Germany | Acceptable 2025-08-14
|
2025-08-14 |