Leukemia Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Imatinib mesylate may stop the growth of cancer cells by
blocking the enzymes necessary for cancer cell growth.
PURPOSE: This phase II trial is studying giving imatinib mesylate together with cytarabine
to see how well it works in treating patients with chronic phase chronic myelogenous
leukemia.
OBJECTIVES:
- 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
unacceptable toxicity.
Patients are followed for 30-60 days.
PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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