drugset / Trial / NCT05390749
Sequential Treatment With RO-MTX After Pomalidomide, Orelabrutinib, Rituximab (POR) in Newly-diagnosed PCNSL
Phase 2
Unknown
50 enrolled
Peking Union Medical College Hospital
Beijing Tiantan Hospital · collabCapital Medical University · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of sequential treatment regimens with RO-MTX after pomalidomide, orelabrutinib, rituximab (POR) in newly-diagnosed primary central nervous system lymphoma, and explore the feasibility of chemo-free treatment in PCNSL. The primary objective was the overall response rate (ORR; defined as partial response \[PR\] or better) after 4 cycles of POR.
Timeline
- Start
- 2022-04-11
- Primary completion
- 2024-04-01
- Completion
- 2026-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | 3.5 g | — |
| Subject | Orelabrutinib | Small molecule | 150 mg | Oral |
| Subject | Pomalidomide | Other / unclassified | 4 mg | — |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |