A Study to Determine the Safety and Efficacy of STI571 in Patients With Chronic Myeloid Leukemia Who Are Hematologically or Cytogenetically Resistant or Refractory to Interferon-Alpha, or Intolerant of, Interferon-Alpha
OBJECTIVES: I. Evaluate the safety profile of STI571 in patients with Philadelphia
chromosome positive (or chromosome negative and Bcr/Abl positive) chronic phase chronic
myelogenous leukemia who are refractory to or intolerant of interferon alfa. II. Provide
expanded access of this treatment to these patients. III. Confirm the rate of complete and
major cytogenetic response in patients treated with this regimen, as demonstrated by a
decrease in the percentage of Philadelphia chromosome positive cells in the bone marrow. IV.
Evaluate the improvement of symptomatic parameters in patients treated with this regimen.
OUTLINE: This is an expanded access, multicenter study. Patients receive oral STI571 daily.
Treatment continues for 12 months in the absence of disease progression or unacceptable
toxicity. Patients who respond after 12 months may continue with therapy.
PROJECTED ACCRUAL: Not determined
Primary Purpose: Treatment
United States: Federal Government
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