Pusan National University Hospital – Chronic Myeloid Leukemia

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Research Hypothesis:

Treatment with dasatinib 100 mg QD is superior to imatinib 600 mg QD in terms of complete
cytogenetic response (CCyR) in chronic phase (CP) Philadelphia chromosome-positive (Ph+)
Chronic Myeloid Leukemia (CML) subjects who are imatinib failures or who have achieved only
a suboptimal response after 3-18 months (12-77 weeks) of therapy with imatinib 400 mg.

Primary Objective:

The primary objective of this study is to compare the rate of CCyR of dasatinib (100mg QD)
to high-dose imatinib (600 mg QD) therapy at 6 months after randomization in CP Ph+ CML
subjects who are imatinib failures or who have achieved only a suboptimal response after 3 –
18 months of imatinib monotherapy at 400 mg/day.