Conditions: Chronic Myeloid Leukemia Philadelphia-Positive Myeloid Leukemia
Keywords: Chronic Phase Philadelphia chromosome Positive (Ph+) chronic myeloid leukemia
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 150
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.

Detailed description:

Arms:
arm 1: Active Comparator arm 2: Active Comparator

Interventions: intervention 1: Dasatinib intervention 2: Imatinib
Intervention descriptions: intervention 1: Tablets, oral, 20 mg and 50mg, twice daily, up to 96 weeks intervention 2: Tablets, Oral, 400mg and 100mg, twice daily, up to 96 weeks

Protocol document: