Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

• Status: Withdrawn
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the recommended dose for the combination of dasatinib and bendamustine in chronic lymphocytic leukemia (CLL).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Bendamustine Hydrochloride; Dasatinib

Criteria

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