A Phase II Study to Determine the Activity of BMS-354825 in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who Are Intolerant of Imatinib
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Imatinib-resistant Participants With Major Cytogenetic Response (MCyR)
Cytogenetic response was based on the prevalence of Ph+ metaphases among cells with metaphases in a bone marrow sample. MCyR is the combination of Complete Cytogenetic Response (CCyR)-0% Ph+ metaphases plus Partial Cytogenetic Response (PCyR)-1% to 35% Ph+ metaphases.
2 years
No
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
CA180-013
NCT00101660
February 2005
April 2008
Name | Location |
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Local Institution | Chicago, Illinois |
Local Institution | Indianapolis, Indiana |
Local Institution | Baltimore, Maryland |
Local Institution | Bronx, New York |
Local Institution | Portland, Oregon |
Local Institution | Vancouver, Washington |
Local Institution | Corona, California |
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 | Lincoln, Nebraska |
Local Institution | New Brunswick, New Jersey |
Local Institution | Duncansville, Pennsylvania |
Local Institution | North Charleston, South Carolina |
Local Institution | Austin, Texas |
Local Institution | Rome, Georgia |
Local Institution | Chattanooga, Tennessee |
Local Institution | Columbia, Missouri |
Local Institution | Detroit, Michigan |