drugset / Trial / NCT05425654
RL-MPV Followed by BBC HCT Using Autologous Stem Cells and Maintenance Therapy With Nivolumab for Newly Diagnosed PCNSL
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the efficacy and safety of the new treatment proposed in this study. Conducting a prospective study "CNS-2015" in patients with PDLBCL CNS made it possible to achieve 2-year EFS, DFS and OS of 83%, 83% and 88%, respectively. The presence of early relapses of the disease has now led to the need to find an alternative program for patients with PDLBCL CNS. In the new "CNS-2021" protocol, lenalidomide was included in the R-MPV program in order to intensify the induction stage. In the conditioning regimen, thiotepa was replaced by carmustine, due to its significant CNS bioavailability. In order to possibly prevent early relapses, an anti-PD-1 inhibitor (nivolumab) was used as maintenance therapy.
Timeline
- Start
- 2021-05-17
- Primary completion
- 2023-05
- Completion
- 2026-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | — | — |
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Lenalidomide | Other / unclassified | — | Oral |
| Subject | Methotrexate | Small molecule | — | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | — |
| Subject | Rituximab | Monoclonal antibody | — | Intravenous |
| Subject | Vincristine | Small molecule | — | Other |
| Subject | carmustine | Small molecule | — | — |
| Subject | procarbazine | Small molecule | — | Oral |