Study of Dasatinib vs Imatinib in Patients With Chronic Myeloid Leukemia (CML) Who Did Not Have Favorable Response to Imatinib

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

Inclusion Criteria:

- Chronic Phase (CP)-CML Ph+ patients with complete hematologic response (CHR) but with
one log BCR-ABL reduction (BCR-ABL level >10% IS) 3 months of imatinib 400mg
treatment. (Imatinib transient dose adjustments due to Adverse Event (AEs) are allowed
with a maximum of 2 weeks interruption of treatment with imatinib (cumulative) within
the 3 month period before randomization). Imatinib monotherapy must have been started
within 6 months of CP-CML diagnosis (Ph + /BCR-ABL detection)

- Currently tolerating imatinib 400mg QD. Patients with prior imatinib treatment
interruption or dose reductions are required to be on treatment with 400 mg imatinib
for two weeks immediately prior to randomization to ensure tolerance to imatinib

- Eastern Co-Operative Group (ECOG) performance status = 0 - 2

- Adequate renal function defined as serum creatinine ≤3 times the institutional upper
limit of normal (ULN)

- Adequate hepatic function defined as: total bilirubin ≤2.0 times the institutional
ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times
the institutional ULN

Exclusion Criteria:

- Previous diagnosis of accelerated phase or blast crisis

- Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases at baseline bone
marrow cytogenetic test, unless the same abnormalities were present at diagnosis.
Patients with no evidence of clonal evolution, including those patients whose
cytogenetic testing fails or bone marrow aspiration is a dry tap at 3 months, are
eligible for the study

- Subjects with less than CHR after 3 months of imatinib treatment or lost CHR after
initial achievement

- Documented T315I/A, F317L, or V299L mutations (if already available - not required for
screening)

- A serious uncontrolled medical disorder or active infection that would impair the
ability of the subject to receive protocol therapy