Phase II Study of Imatinib Mesylate (Gleevec, STI-571) (NSC#716051) and Decitabine (5-AZA-2'-Deoxycitidine) (NSC#127716), in Chronic Myelogenous Leukemia in Accelerated and Blastic Phases
I. Determine the duration of response and response rate in patients with accelerated or
blastic phase chronic myelogenous leukemia treated with imatinib mesylate and decitabine.
II. Determine the survival rate of patients treated with this regimen. III. Determine the
toxicity of this regimen in these patients. IV. Determine the effects of this regimen on
gene methylation in the leukemic cells of these patients.
OUTLINE: Patients are stratified according to prior exposure to imatinib mesylate (yes vs
Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days
per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease
progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 20-80 patients (10-40 per stratum) will be accrued for this
study within 20 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete and partial response
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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