A Phase II Study To Determine The Anti-Leukemic Effects Of STI571 In Combination With Ara-C In Patients With Chronic Myelogenous Leukemia In Chronic Phase
- Determine the rate and duration of complete or major and minor cytogenetic responses
after 6 and 12 months of treatment in patients with chronic phase chronic myelogenous
leukemia treated with imatinib mesylate and cytarabine.
- Determine the rate and duration of complete hematologic responses after 6 and 12 months
of treatment in patients treated with this regimen.
- Determine the rate of molecular response in patients with a complete cytogenetic
response after 6 and 12 months of treatment with this regimen.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive oral imatinib mesylate on days 1-28 and cytarabine subcutaneously on days
15-28. Courses repeat every 28 days for 12 months in the absence of disease progression or
Patients are followed for 30-60 days.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The Rate of Major Cytogenetic Response at 6 Months
Cytogenetic response is defined in terms of the percentage of Philadelphia (Ph) chromosome. Major cytogenetic response is defined as 0-34% Ph-positive cells.
Brian J. Druker, MD
OHSU Knight Cancer Institute
United States: Federal Government
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|OHSU Knight Cancer Institute||Portland, Oregon 97239|