drugset / Trial / NCT01096992
Fludarabine, Bendamustine, and Rituximab (FBR) for Relapsed Chronic Lymphocytic Leukemia (CLL)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of bendamustine, combined with fludarabine and rituximab, that can be given to patients who have CLL that has been treated before. The goal of Phase 2 of this study is to find out if this drug combination can help to control the disease. The safety of this drug combination will also be studied.
Timeline
- Start
- 2010-04-19
- Primary completion
- 2017-03-31
- Completion
- 2017-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Bendamustine | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Bendamustine | Small molecule | 40 mg/m2 | Intravenous |
| Subject | Bendamustine | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Fludarabine | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 500 mg/m2 | Intravenous |