Chronic Myeloid Leukemia Clinical Trial
Official title:
Phase I/II Trial to Study the Dose, Tolerability and the Effectiveness of Imatinib in Combination With Daunorubicine and Cytarabine for Patients With Chronic Myelogenous Leukemia in Myeloid Acute Phase
The aim of this phase I/II trial is to determine the dose of daunorubicine to be associated with cytarabine and Imatinib for induction therapy in patients with chronic myelogenous leukemia in myeloid acute phase.
Study design Imatinib: starting at day –3: 600mg/day; continuous administration In
combination with cytarabine: continuous iv/24h: 100mg/m² ; 7 days and daunorubicine: 4
levels
level 1: 0
level 2: 15mg/m² ; 3 days
level 3: 30mg/m² ; 3 days
level 4: 45mg/m² ; 3 days
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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