The Randomized Study of Dasatinib and High-Dose Imatinib (600mg) in Suboptimal Responder
Status:
Available
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.