A Multi-center, Open-label, Exploratory Study of Bcr-Abl Kinetics in Adult Patients on Nilotinib With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) and a Suboptimal Molecular Response to Imatinib

Select

Inclusion Criteria:

- Male or female patients

- 18 years of age with a con-firmed diagnosis of Ph+ CML-CP and CCyR

- Patients treated with an imatinib dose of 400 mg qd (at least 6 consecutive months
for Group 1 patients)

- A suboptimal molecular response to imatinib defined as:

- Group 1: Treated with 1 year of imatinib, CCyR but no MMR (Bcr-Abl levels
>0.1%IS);

- Group 2: No specific duration of imatinib required, achieved CCyR but has >1 log
increase in Bcr-Abl transcript levels

- Adequate end organ function

Select Exclusion Criteria:

- Prior accelerated phase or blast crisis CML

- Patients achieving prior CCyR on imatinib who lost cytogenetic response prior to
entering study

- Previously documented T315I mutations

- Prior therapy with any other tyrosine kinase inhibitor except imatinib

- Patients with contraindications to receiving nilotinib, including concomitant
medications