Phase 1 Trial of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

Inclusion 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