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
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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the tolerability and the effectiveness of imatinib in combination with daunorubicine and cytarabine and to determine the recommended dose of daunorubicine to be associated with cytarabine
François GUILHOT, MD
Study Chair
Department of Oncology hematology and Cell therapy, University Hospital , 86021 Poitiers - FRANCE
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
010495
NCT00219765
May 2001
January 2006
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