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Phase 1 Trial of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

Phase 1
18 Years
Not Enrolling
Chronic Lymphocytic Leukemia

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Trial Information

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum tolerated dose (MTD) as assessed by measuring dose limiting toxicities (DLT) at each dosing level

Outcome Time Frame:

From initial dose to the end of three cycles of treatment at each dosing level. Each cycle is 28 days, so approximately 91 days

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

May 2009

Completion Date:

December 2011

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



Local Institution Bronx, New York  
Local Institution Cincinnati, Ohio  
Local Institution Chattanooga, Tennessee