drugset / Trial / NCT02611323
A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment with obinutuzumab, polatuzumab vedotin, and venetoclax in participants with relapsed or refractory FL, and with rituximab, polatuzumab vedotin, and venetoclax in participants with DLBCL. Participants with FL who achieve complete response (CR), partial response (PR), or stable disease (SD) at the end of induction therapy will receive post-induction treatment with obinutuzumab and venetoclax, and participants with DLBCL who achieve CR or PR at the end of induction (EOI) will receive post-induction treatment with rituximab and venetoclax.
Timeline
- Start
- 2016-03-09
- Primary completion
- 2022-08-04
- Completion
- 2022-08-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Subject | Polatuzumab Vedotin | Other / unclassified | 1.4 mg/kg | Intravenous |
| Subject | Polatuzumab Vedotin | Other / unclassified | 1.8 mg/kg | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Venetoclax | Small molecule | 200 mg | — |
| Subject | Venetoclax | Small molecule | 400 mg | — |
| Subject | Venetoclax | Small molecule | 600 mg | — |
| Subject | Venetoclax | Small molecule | 800 mg | — |