Phase 1 Trial of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

Bristol-Myers Squibb1 site in 1 countryMay 2009

ConditionsChronic Lymphocytic Leukemia

InterventionsDasatinib Combination of Bendamustine + Dasatinib

DrugsDasatinib Combination of Bendamustine + Dasatinib

Overview

Phase: Phase 1
Intervention: Dasatinib
Conditions: Chronic Lymphocytic Leukemia
Sponsor: Bristol-Myers Squibb
Locations: 1
Primary Endpoint: Determine the maximum tolerated dose (MTD) as assessed by measuring dose limiting toxicities (DLT) at each dosing level
Status: Withdrawn
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

May 2009

End Date

December 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Eligibility Criteria

Inclusion Criteria

Not provided

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

Arms & Interventions

Cohort #1

Intervention: Dasatinib

Cohort #1

Intervention: Combination of Bendamustine + Dasatinib

Cohort #2

Intervention: Dasatinib

Cohort #2

Intervention: Combination of Bendamustine + Dasatinib

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

The effects of treatment on various biological correlates will also be assayed(From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days)
All response evaluable subjects Cohorts #1 and #2 are assessed for overall response rate(s): complete remission (CR); CR with incomplete marrow recovery (CRi); partial remission (PR); for progressive disease (PD) or stable disease (SD)(From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days)