Status:
TERMINATED
Study of Dasatinib in Patients With Chronic Phase Chronic Myeloid Leukemia and a Suboptimal Response to Imatinib
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Leukemia, Myeloid, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare the efficacy of dasatinib with that of high-dose (800-mg) imatinib in participants with chronic phase chronic myeloid leukemia who achieved only a suboptimal re...
Detailed Description
Participants were randomized 2:1 to dasatinib or high-dose imatinib, respectively. Randomization was stratified by a suboptimal response, defined as a hematologic response less than a complete hematol...
Eligibility Criteria
Inclusion
- Chronic phase Ph\^+ chronic myeloid leukemia (CML) demonstrating only a suboptimal response, defined as a hematologic response that is less than a complete hematologic response after at least 3 months of monotherapy with imatinib, 400 mg; a cytogenic response (CgR) that is less than a partial CgR (PCgR) after at least 6 months of monotherapy with imatinib, 400 mg; a PCgR after at least 12 months of monotherapy with imatinib, 400 mg; or less than a major molecular response with a complete CgR after at least 18 months of monotherapy with imatinib, 400 mg.
- Either gender
- Age of 18 years or older
Exclusion
- Previous diagnosis of accelerated phase or blast crisis CML
- Uncontrolled or significant cardiovascular disease
- History of significant bleeding disorder unrelated to CML
- Concurrent malignancies
- Intolerance of imatinib, 400 mg
- Prior treatment with imatinib at a dose higher than 400 mg
- Prior stem cell transplantation and/or high-dose chemotherapy for CML
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00320190
Start Date
August 1 2006
End Date
January 1 2010
Last Update
October 30 2013
Active Locations (27)
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1
Local Institution
Antwerp, Belgium, 2060
2
Local Institution
Charleroi, Belgium, 6000
3
Local Institution
Helsinki, Finland, 00029
4
Local Institution
Tampere, Finland, 33380