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.