Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

Bristol-Myers Squibb (BMS)

Status and phase

Withdrawn

Phase 1

Conditions

Chronic Lymphocytic Leukemia

Treatments

Drug: Dasatinib

Drug: Combination of Bendamustine + Dasatinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00872976

CA180-182

Details and patient eligibility

About

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

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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