A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.

Key Inclusion Criteria: * Confirmed diagnosis of chronic phase Ph+ CML * Previous first-line treatment with imatinib for a minimum of 2 years; * Patient in complete cytogenetic response; Key Exclusion Criteria: * Previous achievement of MR4.0 at study entry; * Previous treatment with other target cells inhibitors other than imatinib; * Patients with any history of detectable atypical Leukemia transcripts or patients with detectable atypical leukemia transcripts at screening; * Previous anticancer agents for Chronic myeloid leukemia other than imatinib except for cytoreduction; * Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol; * History of other active malignancies within the 5 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively; * Patients who have not recovered from prior surgery; * Treatment with other investigational agents within 4 weeks of Day 1; * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug Other inclusion/exclusion criteria might apply.