Back to results

Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

Primary Purpose

Chronic Lymphocytic Leukemia

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Dasatinib

Combination of Bendamustine + Dasatinib

Dasatinib

Combination of Bendamustine + Dasatinib

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Local Institution
Local Institution
Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort #1

Cohort #2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

The effects of treatment on various biological correlates will also be assayed

Full Information

NCT ID

NCT00872976

First Posted

March 31, 2009

Last Updated

July 19, 2013

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00872976

Brief Title

Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

Official Title

Phase 1 Trial of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Withdrawn

Why Stopped

Business Objectives Changed

Study Start Date

May 2009 (undefined)

Primary Completion Date

December 2011 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Lymphocytic Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort #1

Arm Type

Experimental

Arm Title

Cohort #2

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Dasatinib

Other Intervention Name(s)

BMS-354825, Sprycel

Intervention Description

One Week Initial Treatment for Cohort #1: Dasatinib - Tablets/Oral Solution, at assigned dose level, once daily (QD)

Intervention Type

Drug

Intervention Name(s)

Combination of Bendamustine + Dasatinib

Other Intervention Name(s)

Sprycel, Treanda

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dasatinib

Other Intervention Name(s)

BMS-354825, Sprycel

Intervention Description

One Week Initial Treatment for Cohort #2: Dasatinib - Tablets/Oral Solution, at 100 mg, once daily (QD)

Intervention Type

Drug

Intervention Name(s)

Combination of Bendamustine + Dasatinib

Other Intervention Name(s)

Treanda, Sprycel

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

Time Frame

From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11040

Country

United States

Facility Name

Local Institution

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Local Institution

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

We'll reach out to this number within 24 hrs