STI571 in Treating Patients With Accelerated Phase Chronic Myelogenous Leukemia
RATIONALE: STI571 may interfere with the growth of cancer cells and may be effective treatment for chronic myelogenous leukemia.
PURPOSE: Phase II trial to study the effectiveness of STI571 in treating patients who have accelerated phase chronic myelogenous leukemia.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Accelerated Phase|
|Study Start Date:||June 2000|
|Primary Completion Date:||June 2003 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the safety of STI571 in patients with accelerated phase Philadelphia chromosome positive (or chromosome negative and Bcr/Abl positive) chronic myelogenous leukemia. II. Determine the rate of hematological response to this treatment in these patients. III. Determine the improvements in symptomatic parameters with this treatment in these patients. IV. Determine the cytogenetic response to this treatment in these patients. V. Determine the time to treatment failure in these patients after receiving this treatment.
OUTLINE: Patients receive oral STI571 daily. Treatment continues for at least 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: NCT00006052
|United States, New Jersey|
|Novartis Pharmaceuticals Corporation|
|East Hanover, New Jersey, United States, 07936|
|Study Chair:||Ilana Monteleone||Novartis Pharmaceuticals|