A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy
NCT ID: NCT00362466
Last Updated: 2009-11-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
3 participants
INTERVENTIONAL
2007-04-30
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
50-180 mg once daily (QD)
Dasatinib
Tablets, Oral, Once daily, 5-7 years
B
200-800 mg QD
Imatinib
Tablets, Oral, Once daily, 5-7 years
Interventions
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Dasatinib
Tablets, Oral, Once daily, 5-7 years
Imatinib
Tablets, Oral, Once daily, 5-7 years
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis
* Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg) the subject has received in the past
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2
* Adequate hepatic and renal function
Exclusion Criteria
* Previous diagnosis of accelerated/blast crisis CML
* Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases
* Previous documentation of T315I mutation
* Uncontrolled or significant cardiovascular disease
* Serious uncontrolled medical disorder/active infection
* History of significant bleeding disorder unrelated to CML
* Intolerance to imatinib ≥400 mg
* Concurrent malignancies other than CML
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Dr. Marshall Schreeder
Huntsville, Alabama, United States
Local Institution
Little Rock, Arkansas, United States
Local Institution
Alhambra, California, United States
Local Institution
Anaheim, California, United States
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Beverly Hills, California, United States
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Fullerton, California, United States
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La Jolla, California, United States
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La Verne, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Northridge, California, United States
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Oxnard, California, United States
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Redondo Beach, California, United States
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San Francisco, California, United States
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Santa Maria, California, United States
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Stanford, California, United States
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Aurora, Colorado, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
M.D. Anderson Cancer Center Orlando
Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Kansas City, Kansas, United States
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Hazard, Kentucky, United States
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Ann Arbor, Michigan, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Hackensack, New Jersey, United States
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Buffalo, New York, United States
New York Presbyterian Hospital
New York, New York, United States
New York Medical College
Valhalla, New York, United States
Local Institution
Durham, North Carolina, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Baltimore, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
Santee Hematology/Oncology
Sumter, South Carolina, United States
Local Institution
Dallas, Texas, United States
Local Institution
Houston, Texas, United States
Countries
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Other Identifiers
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CA180-044
Identifier Type: -
Identifier Source: org_study_id