A Phase I/II Trial of STI571 and High-Dose Cytarabine in Myeloid Blast Crisis of Chronic Myeloid Leukemia
I. Determine the maximum tolerated dose of high-dose cytarabine when combined with imatinib
mesylate in patients with blastic phase chronic myelogenous leukemia.
II. Determine the safety of this regimen in these patients. III. Determine the
pharmacokinetics of this regimen in these patients. IV. Determine the frequency of
hematologic and cytogenetic responses, duration of response, and survival of patients
treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of cytarabine.
Phase I: Patients who have not previously received imatinib mesylate receive oral imatinib
mesylate daily on days 1-35. Patients who have previously received imatinib mesylate for at
least 28 days receive oral imatinib mesylate on days 22-35. All patients receive cytarabine
IV over 2 hours every 12 hours on days 29-32. Patients with more than 5% residual blasts in
bone marrow on day 28 receive a second course in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of cytarabine until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that which 2 of 6 patients experience dose-limiting toxicity.
Phase II: Additional patients are treated at the dose level preceding the MTD. Patients are
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity according to NCI/NIH Common Toxicity Criteria
Described by duration, relatedness to treatment, and action taken.
Up to 2 years
University of California at Los Angeles (UCLA )
United States: Food and Drug Administration
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