A Dose-ranging Phase I/II Study of STI571 in Combination With Cytarabin in Patients With First Chronic Phase Chronic Myeloid Leukemia
- Determine the maximum tolerated dose of imatinib mesylate and cytarabine in patients
with newly diagnosed chronic phase chronic myeloid leukemia.
- Determine the feasibility of this regimen as defined by dose-limiting toxicity of this
regimen and treatment-related mortality in no more than 5% of these patients.
- Determine the rate and duration of molecular response, complete hematological response,
and complete cytogenetic response in patients treated with this regimen.
- Determine the time to treatment failure of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of imatinib mesylate and cytarabine.
Patients receive oral imatinib mesylate alone once daily on days 1-21. Patients then receive
oral imatinib mesylate once daily and cytarabine IV over 1-3 hours on days 1-7. Combination
therapy repeats every 28-42 days for 2 courses. Patients then receive maintenance oral
imatinib mesylate once daily. Treatment continues in the absence of disease progression or
Cohorts of 5-20 patients receive escalating doses of imatinib mesylate and cytarabine until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which at least 5/5, 5/10, or 5/20 patients experience dose-limiting toxicity.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study within 2 years.
Primary Purpose: Treatment
Incidence of dose-limiting toxicity and treatment-related toxicity per dose level
J.J. Cornelissen, MD
Daniel Den Hoed Cancer Center at Erasmus Medical Center
United States: Federal Government