Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

Bristol-Myers Squibb (BMS) logo

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Withdrawn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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Cohort #1
Experimental group
Treatment:
Drug: Combination of Bendamustine + Dasatinib
Drug: Combination of Bendamustine + Dasatinib
Drug: Dasatinib
Cohort #2
Experimental group
Treatment:
Drug: Combination of Bendamustine + Dasatinib
Drug: Combination of Bendamustine + Dasatinib
Drug: Dasatinib

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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