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STI571 in Treating Patients With Chronic Myelogenous Leukemia That Has Not Responded to Interferon Alfa

Leukemia 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

Clinical Trial 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 chronic myeloid leukemia that has not responded to interferon alfa.

Clinical Trial Description

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00006053
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 2
Start date June 2000
Completion date March 2003
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