Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

July 19, 2013 updated by: Bristol-Myers Squibb

Phase 1 Trial of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New Hyde Park, New York, United States, 11040
        • Local Institution
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Local Institution
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort #1
Drug: Dasatinib
One Week Initial Treatment for Cohort #1: Dasatinib - Tablets/Oral Solution, at assigned dose level, once daily (QD)
Other Names:
  • BMS-354825
  • Sprycel
Drug: Combination of Bendamustine + Dasatinib

Dasatinib, Tablets/Oral Solution, Oral, 50 mg, then at 80 mg, at 80 mg, and at 100 mg, once daily (QD), at assigned ascending dose, for 28 day cycles for a maximum of six cycles

Bendamustine, injection, IV injection, 50 mg/m²/Day 1 and Day 2, then at 50 mg/m², at 70 mg/m², at 70 mg/m², at assigned ascending dose, once daily 30 minute IV infusion Day 1 and Day 2 for a maximum of six cycles

Other Names:
  • Treanda
  • Sprycel
Drug: Dasatinib
One Week Initial Treatment for Cohort #2: Dasatinib - Tablets/Oral Solution, at 100 mg, once daily (QD)
Other Names:
  • BMS-354825
  • Sprycel
Drug: Combination of Bendamustine + Dasatinib

Dasatinib, Tablets/Oral Solution, Oral, at 100 mg, once daily (QD), for 28 day cycles for maximum of six cycles

Bendamustine, injection, IV injection, 100 mg/m²/Day 1 and Day 2, once daily 30 minute IV infusion Day 1 and Day 2 for maximum of six cycles

Other Names:
  • Treanda
  • Sprycel
Experimental: Cohort #2
Drug: Dasatinib
One Week Initial Treatment for Cohort #1: Dasatinib - Tablets/Oral Solution, at assigned dose level, once daily (QD)
Other Names:
  • BMS-354825
  • Sprycel
Drug: Combination of Bendamustine + Dasatinib

Dasatinib, Tablets/Oral Solution, Oral, 50 mg, then at 80 mg, at 80 mg, and at 100 mg, once daily (QD), at assigned ascending dose, for 28 day cycles for a maximum of six cycles

Bendamustine, injection, IV injection, 50 mg/m²/Day 1 and Day 2, then at 50 mg/m², at 70 mg/m², at 70 mg/m², at assigned ascending dose, once daily 30 minute IV infusion Day 1 and Day 2 for a maximum of six cycles

Other Names:
  • Treanda
  • Sprycel
Drug: Dasatinib
One Week Initial Treatment for Cohort #2: Dasatinib - Tablets/Oral Solution, at 100 mg, once daily (QD)
Other Names:
  • BMS-354825
  • Sprycel
Drug: Combination of Bendamustine + Dasatinib

Dasatinib, Tablets/Oral Solution, Oral, at 100 mg, once daily (QD), for 28 day cycles for maximum of six cycles

Bendamustine, injection, IV injection, 100 mg/m²/Day 1 and Day 2, once daily 30 minute IV infusion Day 1 and Day 2 for maximum of six cycles

Other Names:
  • Treanda
  • Sprycel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Outcome Measure
Time Frame
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)
Time Frame: From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days
From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days
The effects of treatment on various biological correlates will also be assayed
Time Frame: From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days
From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

March 31, 2009

First Submitted That Met QC Criteria

March 31, 2009

First Posted (Estimate)

April 1, 2009

Study Record Updates

Last Update Posted (Estimate)

July 22, 2013

Last Update Submitted That Met QC Criteria

July 19, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA180-182

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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