AIEOP-BFM ALL 2017
Author: Julia Dobke, Janina Heilmann, Last modification: 2024/04/12 https://kinderkrebsinfo.de/doi/e203020
AIEOP-BFM ALL 2017 | International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia |
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Disease | Aacute lymphoblastic leukemia |
Type | International inter-group multi-center open-label randomized clinical trial (Phase III) |
Rationale / Objectives |
Primary study questions
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 with 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 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 postreintensification 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 |
Therapy / Study arms |
pB-ALL (or unknown Immunophenotype)
Trial participants with a pB-ALL will be stratisfied at two timepoints. At timepoint 1 (end of induction therapy) stratification will be done in early HR or in early non-HR. At timepoint 2 (end of consolidation threapy) the stratification in one of the following final risk group takes place, depending on clinical/biological factors and MRD:
Therapy before timepoint 1
All participants are treated with the same therapy.
Therapy after timepoint 1
early HR: Participants fulfilling the criteria for the study-arm early HR, will be randomized after induction and will be treated or with the extended consolidation (standard arm) or the extended consolidation plus Bortezomib (experimental arm).
Therapy after timepoint 2
SR: all participants are treated with chemotherapy without a special intensivation therapy (induction, consolidation, reinduction) followed by maintenance therapy. SR-patients have no primary indication for allogene stem cell transplantation.
T-ALL
Participants with a T-ALL will be stratisfied at 2 timepoints: at timepoint 1 (end of induction therapy) participants will be treated in arm early SR or in early non-SR. At timepoint 2 (end of consolidation therapy) the stratification takes place in one of the folowing risk-groups
Therapy before timepoint 1:
Participants with a T-ALL are devided after the prephase with prednisone in two groups: participants with prednisolone good response, PGR, are treated with an induction therapy with dexamethasone; participants with predinsone poor response, PPR, will be treated with an intensified induction therapy with prednisolone and cyclophosphamide.
Therapy after timepoint 1
Early SR: allparticiiopants are treated with the standard-consolidation
Therapy after timepoint 2
non-HR: the participants will be treated with a mulimodal chemotherapy followe by a maintenance therapy. The have no primary indication for a allogen hematopoetic stem cell transplantation (HSCT). |
Inclusion Criteria |
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Exclusion Criteria |
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Status | Trial start: 15/07/2018, end: 14/07/2028; Update: for patients with B-precursor ALL recruitment stop by 31/08/2023; for patients with T-ALL recruitment stop by 31/03/2024 |
EudraCT | AIEOP-BFM 2017 2016-001935-12 |
Entry Study Register | |
Principal Investigator | Prof. Dr. med. Martin Schrappe |
all-bfm-studie@pediatrics.uni-kiel.de | |
Contact |
Coordinating principal investigatorProf. Dr. med. Martin Schrappe Univ.-Klinikum Schleswig-Holstein, Campus Kiel Klinik für Kinder- und Jugendmedizin I Arnold-Heller-Str. 3 24105 Kiel Telefon +49 (431) 500 20102 Fax +49 (431) 500 20104 Trial coordinationDr. med. Anja Möricke Univ.-Klinikum Schleswig-Holstein, Campus Kiel Klinik für Kinder- und Jugendmedizin I, AIEOP-BFM ALL Studienzentrale Arnold-Heller-Straße 3 24105 Kiel Telefon +49 (431) 500 20150 Fax +49 (431) 500 20144 a.moericke@pediatrics.uni-kiel.de Dr. med. Julia Alten Univ.-Klinikum Schleswig-Holstein, Campus Kiel Klinik für Kinder- und Jugendmedizin I, AIEOP-BFM ALL Studienzentrale Arnold-Heller-Straße 3 24105 Kiel Telefon +49 (431) 500 20139 Fax +49 (431) 500 20144 julia.alten@uksh.de Dr. med. Janina Heilmann Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik für Kinder- und Jugendmedizin 1 Arnold-Heller-Straße 3 24105 Kiel Telefon +490431 500 20139 Fax +49431 500 20144 janina.heilmann@ukse.de Dr. med. Swantje Buchmann Telefon +49 - 431 - 500 20139 swantje.buchmann@uksh.de Trial documantation |
Participants | AIEOP (Italien) BFM-A (Österreich) BFM-G (Deutschland) BFM-CH (Schweiz) ANZCHOG (Australien) CPH (Tschechische Republik) INS (Israel) SPHOS (Slowakei) |
Sponsoring | Sponsor: Universitätsklinikum Schleswig-Holstein, Campus Kiel |