A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Inclusion criteria:

- Chronic myelogenous leukemia in chronic phase patients within the first 6 months of
diagnosis.

- Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of
Philadelphia chromosome of (9:22) translocations

Exclusion criteria:

- Previously documented T315I mutation

- Treatment with a tyrosine kinase inhibitor prior to study entry is not allowed except
for no more than 2 weeks in duration of imatinib

- Any medical treatment for CML prior to study entry for longer than 2 weeks with the
exception of hydroxyurea and/or anagrelide

- Impaired cardiac function.

- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or
uncontrolled infection).

- Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)

- Currently receiving treatment with any medications that have the potential to prolong
the QT interval.

Other protocol-defined inclusion/exclusion criteria may apply