drugset / Trial / NCT04899427
Phase II Study of Orelabrutinib Combined With PD-1 Inhibitor in Relapsed/Refractory Primary Central Nervous System Lymphoma
Phase 2
Unknown
32 enrolled
Peking Union Medical College Hospital
Beijing Hospital · collabBeijing Luhe Hospital · collabBeijing Tongren Hospital · collabHebei Medical University Fourth Hospital · collabHenan Cancer Hospital · collabHenan Province Renmin Hospital · collabQilu Hospital of Shandong University · collabShanxi Province Renmin Hospital · collabThe First Affiliated Hospital of Zhengzhou University · collabThe First Hospital of Chinese Medical University · collabThe Second Affiliated Hospital of Dalian Medical University · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a prospective multicenter single-arm phase II study, and the purpose of this study is to evaluate the efficiency of Orelabrutinib combined with PD-1 inhibitor regimen relapsed/refractory primary intraocular lymphoma. Overall response rate （ORR） after 4 cycles is the primary endpoint.
Timeline
- Start
- 2021-03-24
- Primary completion
- 2023-03-24
- Completion
- 2023-10-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Orelabrutinib | Small molecule | 150 mg | Oral |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |