CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib

Inclusion Criteria:

Patients with Ph+ CML-CP within 3 months of diagnosis. Male or female patients' ≥ 18 years
of age. Patients must have adequate end organ function.

Exclusion Criteria:

Previously documented T315I mutation. Other CML treatment is an exclusion criteria with
the following exception: While awaiting study start, patients may be treated with
anagrelide (no treatment duration limit), hydroxyurea (no treatment duration limit),
and/or up to a 14 day supply of a tyrosine kinase inhibitor (TKI) approved by the FDA for
frontline treatment. Patients taking a TKI prior to study entry must have at least a one
day washout from their last dose of medication and have recovered from any side effects of
such therapy.

Impaired cardiac function as defined by the protocol. Patients with contraindications to
receiving nilotinib, including concomitant medications.