Status:
WITHDRAWN
Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the recommended dose for the combination of dasatinib and bendamustine in chronic lymphocytic leukemia (CLL).
Eligibility Criteria
Inclusion
- Inclusion Criteria (Cohort #1):
- Diagnosis of B-CLL by NCI criteria
- Require chemotherapy and have fully recovered from previous administered chemotherapy
- Subjects must have progressed, failed to achieve a meaningful response, or relapsed/intolerant to prior therapy. Failing at least one purine analogue regimen
- Subjects have received three or fewer prior treatment regimens
- ECOG status of 0 - 2
- Inclusion Criteria (Cohort #2):
- If dose level + 3 is reached, the criteria is the same as outlined for Cohort #1, however the subjects should not have a history of prior chemotherapy (treatment naive)
- Exclusion Criteria:
- Unwilling or unable to use an acceptable method to avoid pregnancy
- Uncontrolled or significant cardiovascular disease, including prolonged QTc interval
- History of significant bleeding disorder, unrelated to CLL
- Prior concurrent malignancy
- Drugs that generally accepted to have the risk of causing Torsades de Pointes
- Autoimmune hemolytic anemia requiring therapy or transfusion support
- Autoimmune thrombocytopenia requiring steroid therapy or transfusion support
- Richter's Syndrome
- Transformation to prolymphocytic leukemia
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00872976
Start Date
May 1 2009
End Date
December 1 2011
Last Update
July 22 2013
Active Locations (3)
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1
Local Institution
New Hyde Park, New York, United States, 11040
2
Local Institution
Columbus, Ohio, United States, 43210
3
Local Institution
Nashville, Tennessee, United States, 37203