Conditions: Chronic Myeloid Leukemia
Keywords: Bosutinib imatinib CML
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 502
Healthy volunteers: no

Brief summary:
Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.

Detailed description:

Arms:
arm 1: Bosutinib arm 2: Imatinib

Interventions: intervention 1: Bosutinib intervention 2: imatinib
Intervention descriptions: intervention 1: 500 mg once daily, by mouth (tablet) with food preferably in the morning. Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent. intervention 2: 400 mg once daily, by mouth (tablet). Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent.

Protocol document: