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:

1. Male or female patients ≥ 18 years of age

2. ECOG 0, 1, or 2

3. Diagnosis of CML-CP associated with Bcr-Abl quantifiable by RQ-PCR (IS)

4. 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

5. CML-CP patients initiated on any dose of imatinib

6. Ability to provide written informed consent prior to any study related screening
procedures being done

Exclusion Criteria:

1. Loss of CHR or cytogenetic response

2. Prior accelerated phase or blast phase CML

3. Previously documented T315I mutation

4. Presence of chromosomal abnormalities (trisomy 8) and/or clonal evolution other than
Ph+.

5. Previous treatment with any other tyrosine kinase inhibitor except for imatinib.

6. Treatment with other investigational agents within 30 days of Day 1.

7. History of non-compliance to medical regimens or inability to grant consent.

8. 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