EsPhALL2017 / COGAALL1631
Author: Anja Möricke, Julia Dobke,, Last modification: 2024/04/12 https://kinderkrebsinfo.de/doi/e80111
EsPhALL2017 / COGAALL1631 | International phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones |
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Disease | Paediatric patients with Ph+/BCR-ABL+ acute lymphoblastic leukemia (Ph+ALL) |
Type | International, prospective, multicenter therapy trial for the treatment of children and adolescents (>1-<21 years) with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) |
Rationale / Objectives |
Ca. 3-5 % of the cases with ALL in children and adolescents are characterized with the evidence of the Philadelphia-Chromosome (translocation t(9;22), molekular equivalence: BCR-ABL-fusion). Since the introduction of tyrosine kinase inhibitors in the treatment of Ph+ patients, more than half of the patients can be healed withou HSCT. But historically european as well as american studies used high intensive chemotherapies with severe the side effects. The reduction of these adverse events despite an acceptable relapse rate would be an important progress in the treatment of this children and adolescents.
Primary objectives
Secondary objectices
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Therapy / Study arms |
Stratification:
Therapy:
High-risk patients: HR patients (approximately 15-20% of patients), allogeneic HSCT in CR1 is still considered the treatment of choice. On EsPhALL 2017/COG AALL1631, HR patients will receive the EsPhALL chemotherapy backbone and proceed to HSCT after completion of the three consolidation blocks. |
Inclusion Criteria |
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Exclusion Criteria |
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Recruitment | 700 |
Status | Start: 02/01/2019 |
EudraCT | 2017-000705-20 |
Entry Study Register | |
Principal Investigator | Prof. Dr. Andrea Biondi |
Contact |
Investigator BFM-Germany and SwizzerlandProf. 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 m.schrappe@pediatrics.uni-kiel.de Coordination BFMDr. 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 Coordination CoALLPD Dr. med. Gabriele Escherich Universitätsklinikum Hamburg-Eppendorf Klinik und Poliklinik f. Päd. Hämatologie u. Onkologie Martinistraße 52 20246 Hamburg Telefon +49 (40) 42803 3796 / 74 10- 5 2580 Fax +49 (40) 42803 3608 escherich@uke.uni-hamburg.de |
Participants | AIEOP, BFM-G/CH and BFM-A, COALL, DCOG, EORTC, FRALLE, UKALL, NOPHO, Chzech Republic, Poland, Slovakia, Israel, PINDA (Chile), HKPHOSG (Hong Kong) |
Link(s) | literature on ALL |