drugset / Trial / NCT01671904
A Study of Venetoclax in Combination With Bendamustine + Rituximab or Bendamustine + Obinutuzumab in Participants With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics of venetoclax (GDC-0199, ABT-199) administered in combination with bendamustine and rituximab (BR) (MabThera/Rituxan) or bendamustine and obinutuzumab (BG) to participants with first-line (1L)/previously untreated or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). The study will explore two venetoclax combination regimens in participants with 1L CLL: BR+venetolax (V) and BG+V. Participants with R/R CLL will be administered BR+V.
Timeline
- Start
- 2014-01-13
- Primary completion
- 2018-08-17
- Completion
- 2020-08-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Venetoclax | Small molecule | — | Oral |
| Background | Bendamustine | Small molecule | 70 mg/m2 | Intravenous |
| Background | Bendamustine | Small molecule | 90 mg/m2 | Intravenous |
| Background | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Background | Rituximab | Monoclonal antibody | 500 mg/m2 | Intravenous |