Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

Phase 1 Trial of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00872976
• Other study ID #: CA180-182
• Status: Withdrawn
• Phase: Phase 1
• First received: March 31, 2009
• Last updated: July 19, 2013
• Start date: May 2009
• Est. completion date: December 2011

Study information

• Verified date: July 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Dasatinib
One Week Initial Treatment for Cohort #1: Dasatinib - Tablets/Oral Solution, at assigned dose level, once daily (QD)
• 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
• Dasatinib
One Week Initial Treatment for Cohort #2: Dasatinib - Tablets/Oral Solution, at 100 mg, once daily (QD)
• 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

Locations

Country	Name	City	State
United States	Local Institution	Columbus	Ohio
United States	Local Institution	Nashville	Tennessee
United States	Local Institution	New Hyde Park	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form