Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
The Cleveland Clinic
With
OBJECTIVES: Primary * 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. Secondary * 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 patients. 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
