Clinical Trial: STI571 in Treating Patients With Chronic Myelogenous Leukemia in Blast Crisis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open-Label Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Blast Crisis

Brief Summary:

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.

Detailed Summary:

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

Sponsor: Novartis

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Novartis

Dates:
Date Received: November 6, 2000
Date Started: September 2000
Date Completion:
Last Updated: February 20, 2013
Last Verified: February 2013