Clinical Trial: STI571 in Treating Patients With Accelerated Phase Chronic Myelogenous Leukemia

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

Official Title: A Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Accelerated Phase

Brief Summary:

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.

Detailed Summary:

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

Sponsor: Novartis

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Novartis

Dates:
Date Received: July 5, 2000
Date Started: June 2000
Date Completion:
Last Updated: January 30, 2014
Last Verified: January 2014