Conditions: CHRONIC MYELOGENOUS LEUKEMIA
Keywords: MYELOGENOUS LEUKEMIA Chronic Phase CML
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 207
Healthy volunteers: no

Brief summary:
The primary goal of this study was to determine the rate of confirmed best cumulative complete molecular response (CMR) within the first year of study therapy with imatinib or nilotinib. The study also explored the impact and significance of the achieved CMR on patient outcomes (progression free survival (PFS), event free survival (EFS) and overall survival (OS), characterized the kinetics of CMR achieved in both treatment arms and after the cross-over.

Detailed description:

Arms:
arm 1: Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months. arm 2: Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.

Interventions: intervention 1: Nilotinib intervention 2: Imatinib
Intervention descriptions: intervention 1: Supplied in 200 mg capsules intervention 2: Supplied in 100 mg and 400 mg capsules

Protocol document: