STI571 in Treating Patients With Chronic Myelogenous 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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||An Open-Label Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Blast Crisis|
|Study Start Date:||September 2000|
|Study Completion Date:||December 2002|
|Primary Completion Date:||December 2002 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006475
|United States, New Jersey|
|Novartis Pharmaceuticals Corporation|
|East Hanover, New Jersey, United States, 07936|
|Study Chair:||Ilana Monteleone||Novartis Pharmaceuticals|