A Phase IV, Open-label, Multicenter Study of Dasatinib in Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Patients With Chronic, Low-grade Non-Hematologic Toxicity to Imatinib

Inclusion Criteria:

- Patients with CML-CP patients achieving an optimal response to imatinib treatment
with Grade 1 or 2 non-hematologic adverse events persisting for at least 2 months or
recurring at least 3 times in the preceding 12 months, despite best supportive care

- Men and women with Chronic Myeloid Leukemia- Chronic Phase (CML-CP) Ph+ ≥ age 18

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

- Patient willing and able to give informed consent

- Life expectancy > 6 months

- Adequate renal function

- Adequate hepatic function

Exclusion Criteria:

- Patients who are pregnant or breast feeding

- Men whose partner is unwilling to avoid pregnancy.

- Previous treatment with any other tyrosine-kinase inhibitor (TKI), except for
imatinib

- Current grade 3 or 4 imatinib related adverse event

- Prior documented T315I mutation

- Prior diagnosis of accelerated phase or blast crisis CML

- Previous loss of complete hematologic response (CHR) or major cytogenetic response
(MCyR) on imatinib

- Concurrent medical condition of uncontrolled infection, cardiovascular diseases of
cardiac failure, congenital long QT syndrome, ventricular arrhythmias, prolonged QT
interval, second or third degree heart block, uncontrolled angina, myocardial
infarction (MI) in the last 6 months, uncontrolled hypertension, pulmonary arterial
hypertension, pleural or pericardial effusions, or history of bleeding disorder