A Phase I Trial of Imatinib Mesylate (Gleevec, Formerly Known as STI571) in Combination With Daunorubicin and Cytarabine for C-kit Positive Relapsed AML
- Determine the maximum tolerated dose (MTD) and recommended phase II dose of imatinib
mesylate in combination with daunorubicin hydrochloride and cytarabine in patients with
relapsed acute myeloid leukemia.
- Assess the non-dose-limiting toxicities associated with this regimen in these patients.
- Determine any preliminary evidence of clinical activity of this regimen in these
OUTLINE: This is an open-label, dose-escalation study of imatinib mesylate.
Patients receive daunorubicin IV on days 1-3 and cytarabine IV continuously on days 1-7.
Patients also receive oral imatinib mesylate once daily beginning on day 1 and continuing
until disease progression or unacceptable toxicity. Patients with persistent leukemia on day
14 bone marrow biopsy but ≥ 50% reduction in bone marrow blasts receive 5 more days of
cytarabine and 2 more days of daunorubicin while continuing imatinib mesylate.
Cohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1
of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated
at the MTD.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of imatinib mesylate at one year
Anjali Advani, MD
The Cleveland Clinic
United States: Federal Government
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