drugset / Trial / NCT00949988
A Study of Dasatinib and Rituximab for Relapsed/Refractory Chronic Lymphocytic Leukemia
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label phase I/II study that will investigate the combination of dasatinib and rituximab therapy in patients with relapsed/refractory CLL. In phase I, eligible subjects will take either 100 mg or 140 mg of dasatinib daily along with rituximab on day 1 of each cycle for 6 cycles. In phase II, eligible subjects will all receive the same dose of dasatinib, as established in the phase I portion, along with rituximab on day 1 of each cycle for 6 cycles. The investigators hypothesize that the combination of dasatinib and rituximab will demonstrate efficacy in the treatment of patients with relapsed/refractory CLL.
Timeline
- Start
- 2009-05
- Primary completion
- 2012-04
- Completion
- 2012-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Rituximab | Monoclonal antibody | 500 mg/m2 | — |
| Comparator | dasatinib anhydrous | Small molecule | 70 mg | — |
| Comparator | dasatinib anhydrous | Small molecule | 100 mg | — |
| Comparator | dasatinib anhydrous | Small molecule | 140 mg | — |