An Open-Label Study to Determine the Efficacy and Safety of STI571 in Patients With Chronic Myeloid Leukemia in Blast Crisis
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
Interventional
Primary Purpose: Treatment
Ilana Monteleone
Study Chair
Novartis Pharmaceuticals
United States: Federal Government
CDR0000068302
NCT00006475
September 2000
December 2002
Name | Location |
---|---|
Novartis Pharmaceuticals Corporation | East Hanover, New Jersey 07936 |