This is a Phase Ib/IIa open-labeled multi-center trial evaluating the feasibility of dasatinib given after standard induction therapy with daunorubicin (DNR) and cytarabine (ARA-C), after consolidation therapy with high-dose cytarabine (HDAC), and as single agent in a one-year maintenance therapy in patients with newly diagnosed CBF AML. 82 patients with newly diagnosed CBF AML will be enrolled at AMLSG study centers. All AML patients will be assessed for the CBF fusion genes via the central laboratory of the AMLSG within 48 hours of diagnosis of AML, and only patients with CBF AML will be enrolled into the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
89
Induction cycle(s): Dasatinib 100 mg QD on days 8-21. Consolidation Cycles 1, 2, 3, 4: Patients will receive dasatinib 100 mg QD on days 6-28. Maintenance therapy: Patients completing consolidation therapy will continue to receive single agent dasatinib 100 mg QD for one year (or until relapse).
Induction cycle(s): Daunorubicin 60 mg/m2/day administered on days 1 through 3
Induction cycle(s): Cytarabine 200 mg/m2/day administered by continuous IV infusion daily for 7 days (days 1 through 7). Consolidation cycles 1, 2, 3, 4: Consolidation therapy consists of high-dose cytarabine 3 g/m2 (\>60 years: 1 g/m2) q12h, d 1, 3, 5, administered intravenously over three hours.
Universitätsklinikum Innsbruck
Innsbruck, Austria
Krankenhaus der Barmherzigen Schwestern
Linz, Austria
Elisabethinen Krankenhaus
Linz, Austria
Landeskliniken Salzburg
Salzburg, Austria
Hanuschkrankenhaus Wien
Vienna, Austria
Ubbo-Emmius Klinik Aurich
Feasibility as combined endpoint: Rate of ED/HD Rate of pleural/pericardial effusion grade 3/4 Rate of liver toxicity grade 3/4 that does not improve to <= grade 2 within 14 days after discontinuing responsible medication Rate of refractory disease
Time frame: after 4 weeks
Cumulative incidence of relapse (CIR) and death (CID)
Time frame: After follow-up period of two years
Overall survival (os)
Time frame: After follow-up period of two years
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Aurich, Germany
Charité Universitätsmedizin Berlin
Berlin, Germany
Universitätsklinikum Bonn
Bonn, Germany
Städtisches Klinikum Braunschweig
Braunschweig, Germany
Klinikum Bremen-Mitte gGmbH
Bremen, Germany
...and 40 more locations