drugset / Trial / NCT04138875
A Risk Stratified Sequential Treatment With Rituximab, Brentuximab Vedotin and Bendamustine (RBvB)
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an open label, risk-stratified, sequential treatment, phase 2 study of newly diagnosed post-transplant lymphoproliferative disorders with positive CD20 and CD30 expression. It includes an induction phase with rituximab and brentuximab vedotin (RBv), followed by a treatment phase with RBv or RBv in combination with bendamustine (RBvB) based on response to induction. The primary end point is treatment efficacy measured as the overall response rate (ORR) and progression free survival (PFS).
Timeline
- Start
- 2022-01
- Primary completion
- 2023-09
- Completion
- 2023-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bendamustine | Small molecule | 90 mg/m2 | Intravenous |
| Comparator | Brentuximab Vedotin | Monoclonal antibody | 1.8 mg/kg | Intravenous |
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |