STI571 in Treating Patients With Chronic Myelogenous Leukemia That Has Not Responded to Interferon Alfa
|ClinicalTrials.gov Identifier: NCT00006053|
Recruitment Status : Completed
First Posted : May 4, 2004
Last Update Posted : January 18, 2013
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 chronic myeloid leukemia that has not responded to interferon alfa.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: imatinib mesylate||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||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|
|Study Start Date :||June 2000|
|Actual Primary Completion Date :||March 2003|
|Actual Study Completion Date :||March 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006053
|United States, New Jersey|
|Novartis Pharmaceuticals Corporation|
|East Hanover, New Jersey, United States, 07936|
|Study Chair:||Ilana Monteleone||Novartis Pharmaceuticals|