Chronic Lymphocytic Leukemia
Conditions
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).
Interventions
DRUGDasatinib
One Week Initial Treatment for Cohort #1: Dasatinib - Tablets/Oral Solution, at assigned dose level, once daily (QD)
DRUGCombination 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
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| 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) | 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 |
Countries
United States
Outcome results
None listed