Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

Phase 1

Withdrawn

• Conditions: Chronic Lymphocytic Leukemia
• Interventions: Drug: Dasatinib; Drug: Combination of Bendamustine + Dasatinib

• Registration Number: NCT00872976
• Lead Sponsor: Bristol-Myers Squibb

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-31
• Study First Submitted QC: 2009-03-31
• Study First Posted: 2009-04-01
• Study Start: 2009-05
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-19
• Last Update Posted: 2013-07-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort #1	Dasatinib	-
Cohort #1	Combination of Bendamustine + Dasatinib	-
Cohort #2	Dasatinib	-
Cohort #2	Combination of Bendamustine + Dasatinib	-

Primary Outcome Measures

Name	Time	Method
Determine the maximum tolerated dose (MTD) as assessed by measuring dose limiting toxicities (DLT) at each dosing level	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Nashville, Tennessee, United States