Clinical trial · Interventional
Study of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia
Phase 1 Trial of Dasatinib and Bendamustine in Chronic Lymphocytic Leukemia
NCT00872976CI-TRIAL-00011446withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business Objectives Changed
Summary
Brief summary (as posted)
The purpose of this study is to determine the recommended dose for the combination of dasatinib and bendamustine in chronic lymphocytic leukemia (CLL).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination of Bendamustine + Dasatinib | Drug | — | UNRESOLVED |
| Dasatinib | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort #1
- interventionNames
- Drug: Dasatinib
- Drug: Combination of Bendamustine + Dasatinib
- type
- EXPERIMENTAL
- label
- Cohort #2
- interventionNames
- Drug: Dasatinib
- Drug: Combination of Bendamustine + Dasatinib
Primary outcomes (1)
- 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 (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.