Conditions: Leukemia, Myeloid, Chronic Phase
Keywords: CML Philadelphia positive Bcr-abl imatinib mesylate Chronic myeloid leukemia (CML) in chronic phase
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 476
Healthy volunteers: no

Brief summary:
This study investigated the safety and efficacy of 400mg Versus 800mg imatinib in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints.

Detailed description:

Arms:
arm 1: Oral dose of 400mg Imatinib once daily. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol. arm 2: Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.

Interventions: intervention 1: Imatinib mesylate
Intervention descriptions: intervention 1: Imatinib is packaged in bottles as 100mg and 400mg tablets

Protocol document: