Leukemia Clinical Trial
Official title:
An Open-Label Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Blast Crisis
RATIONALE: STI571 may interfere with the growth of cancer cells and may be an effective
treatment for leukemia.
PURPOSE: Phase II trial to study the effectiveness of STI571 in treating patients who have
chronic myelogenous leukemia in blast crisis.
OBJECTIVES: I. Determine the safety profile of STI571 in patients with chronic myelogenous
leukemia in blast crisis. II. Provide expanded access of this treatment to these patients.
III. Determine the rate of hematological response and duration of response in patients
treated with this regimen. IV. Determine the improvements in symptomatic parameters in
patients treated with this regimen. V. Determine the cytogenetic response in patients
treated with this regimen. VI. Determine the overall survival in patients treated with this
regimen.
OUTLINE: This is an expanded-access, multicenter study. Patients receive oral STI571 daily.
Treatment continues for 1 year in the absence of disease progression or unacceptable
toxicity. Patients who are considered to have benefited may continue treatment beyond 1
year.
PROJECTED ACCRUAL: Not determined
;
Primary Purpose: Treatment
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