drugset / Trial / NCT05698147
Selinexor in Combination With MTX+Ritu to Treat R/R CNSL
NaSingle-groupOpen-labelTreatment
Summary
This is a single-arm and open-label study to explore X+MTX+Ritu (ATG-010, Methotrexate, Rituximab) regimen in Relapse refractory PCNSL patients. Approximately 30 patients will be enrolled in the study. In dose escalation phase, patients with Relapse refractory PCNSL will be treated with X+MTX+Ritu regimen and escalating doses of oral ATG-010 weekly in a 3+3 design. Then a phase 2 expansion at the recommended dose level based on phase 1b trial will be conducted to evaluate the efficacy, safety and tolerability.
Timeline
- Start
- 2023-08-03
- Primary completion
- 2026-06-30
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | 3.5 g | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Selinexor | Other / unclassified | 60 mg | Oral |
| Subject | Selinexor | Other / unclassified | 80 mg | Oral |
| Subject | Selinexor | Other / unclassified | 100 mg | Oral |