Leukemia Clinical Trial
Official title:
A Phase I Study of CLAG Regimen in Combination With Imatinib Mesylate (Gleevec) in Refractory or Relapsed Leukemias
RATIONALE: Drugs used in chemotherapy, such as cladribine and cytarabine, work in different
ways to stop the growth of cancer cells, either by killing the cells or by stopping them
from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the
enzymes needed for cell growth. Giving cladribine and cytarabine together with imatinib
mesylate may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate
when given together with cladribine and cytarabine in treating patients with refractory or
relapsed acute myeloid leukemia or blastic phase chronic myelogenous leukemia.
OBJECTIVES:
- Determine the safety and feasibility of cladribine, cytarabine, and imatinib mesylate
in patients with refractory or relapsed acute myeloid leukemia or blastic phase chronic
myelogenous leukemia.
- Determine the maximum tolerated dose of imatinib mesylate in patients treated with this
regimen.
- 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
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