A Randomized Multi-Center Open Label Study of BMS-354825 vs. Imatinib Mesylate (Gleevec) 800 mg/d in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to Imatinib at a Dose at 400 - 600 mg/d
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Major Cytogenetic Response (MCyR) at Week 12
Cytogenetic response was based on the prevalence of Philadelphia chromosome positive (Ph+) metaphases among cells in metaphase on a bone marrow sample (aspirate/biopsy). MCyR was defined as Complete CyR (CCyR; 0% Ph+ cells in metaphase in bone marrow) or Partial CyR (PCyR; >0% to 35% Ph+ cells in metaphase in bone marrow).
Week 12
No
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
CA180-017
NCT00103844
February 2005
March 2008
Name | Location |
---|---|
Local Institution | Chicago, Illinois |
Local Institution | Indianapolis, Indiana |
Local Institution | Portland, Oregon |
Local Institution | Vancouver, Washington |
Local Institution | Birmingham, Alabama |
Local Institution | Corona, California |
Local Institution | Aurora, Colorado |
Local Institution | Hamden, Connecticut |
Local Institution | Washington, District of Columbia |
Local Institution | Fort Lauderdale, Florida |
Local Institution | Wichita, Kansas |
Local Institution | Springfield, Massachusetts |
Local Institution | Duluth, Minnesota |
Local Institution | Lincoln, Nebraska |
Local Institution | New Brunswick, New Jersey |
Local Institution | Wilmington, North Carolina |
Local Institution | Oklahoma City, Oklahoma |
Local Institution | Duncansville, Pennsylvania |
Local Institution | North Charleston, South Carolina |
Local Institution | Austin, Texas |
Local Institution | Arlington, Virginia |
Local Institution | Rome, Georgia |
Local Institution | Chattanooga, Tennessee |
Local Institution | Columbia, Missouri |
Local Institution | Louisville, Kentucky |