Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00872976

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia	Drug: Dasatinib Drug: Combination of Bendamustine + Dasatinib Drug: Dasatinib Drug: Combination of Bendamustine + Dasatinib	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 1 Trial of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

Study Start Date :

May 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2011

Anticipated Study Completion Date :

Dec 1, 2011

Arms and Interventions

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: Sprycel Treanda
Experimental: Cohort #2	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

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:

Sprycel

Treanda

Experimental: Cohort #2

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

Outcome Measures

Primary Outcome Measures

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

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	New Hyde Park	New York	United States	11040
2	Local Institution	Columbus	Ohio	United States	43210
3	Local Institution	Nashville	Tennessee	United States	37203