An Exploratory Trial to Assess the Improvement of Adverse Events in Chronic Myelogenous Leukemia Patients Treated With Imatinib When Switched to Nilotinib Treatment

Inclusion Criteria:

Male or female patients ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) 0, 1, or 2
Diagnosis of leukemia-cml/" >CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS)
Patients must be an imatinib responder and achieved the following efficacy milestones as appropriate for the length of time on imatinib therapy as per protocol
CML-CP patients initiated on any dose of imatinib
Ability to provide written informed consent prior to any study related screening procedures being done

Exclusion Criteria:

Loss of CHR or cytogenetic response
Prior accelerated phase or blast phase CML
Previously documented T315I mutation
Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than Ph+.
Previous treatment with any other tyrosine kinase inhibitor except for imatinib.
Treatment with other investigational agents within 30 days of Day 1.
History of non-compliance to medical regimens or inability to grant consent.
Women who are pregnant, breast feeding, or of childbearing potential without a negative serum test at baseline. Male or female patients of childbearing potential unwilling to use contraceptive precautions throughout the trial and 3 months following discontinuation of study drug. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women of childbearing potential must have a negative serum pregnancy test prior to the first dose of nilotinib.

Other protocol-defined inclusion/exclusion criteria may apply