A Phase I Study of CLAG Regimen in Combination With Imatinib Mesylate (Gleevec) in Refractory or Relapsed Leukemias
- Determine the safety and feasibility of cladribine, cytarabine, and imatinib mesylate
in patients with refractory or relapsed acute myeloid leukemia or blastic phase chronic
- Determine the maximum tolerated dose of imatinib mesylate in patients treated with this
- Correlate the expression of c-kit and the presence of c-kit mutations with clinical
response in patients treated with this regimen.
- Correlate the in vitro inhibitory effects of imatinib mesylate and cytarabine on the
proliferation and survival of leukemic cells with clinical response in patients treated
with this regimen.
OUTLINE: This is a dose-escalation study of imatinib mesylate.
Patients receive oral imatinib mesylate once daily on days 1-15 and cladribine IV over 2
hours and cytarabine IV over 4 hours on days 3-7. Patients also receive filgrastim (G-CSF)
subcutaneously on days 2-7. Treatment repeats every 15 days for 2 courses in the absence of
disease progression or unacceptable toxicity.
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 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for up to 1 year.
PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.
Primary Purpose: Treatment
Camille Abboud, MD
James P. Wilmot Cancer Center
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|