Clinical trial NCT00872976: 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
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-04-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Determine the maximum tolerated dose (MTD) as assessed by measuring dose limiting toxicities (DLT) at each dosing level
timeFrame: 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 outcomes:
measure: 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)
timeFrame: From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days
measure: The effects of treatment on various biological correlates will also be assayed
timeFrame: From initial dose to the end of six cycles of treatment. Each cycle is 28 days, so approximately 175 days
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Local Institution
state: New York
city: Columbus
country: United States
facility: Local Institution
state: Ohio
city: Nashville
country: United States
facility: Local Institution
state: Tennessee
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: