drugset / Trial / NCT04831658
A Prospective Clinical Study of BTK Inhibitor, PD-1 and Formustine in the First-line Treatment of Primary Central Nervous System Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
To observe the efficacy and safety of a new generation of BTK inhibitor Orelabrutinib combined with PD-1 and fotemustine in the treatment of patients with primary central nervous system lymphoma (PCNSL).
Timeline
- Start
- 2021-03-29
- Primary completion
- 2023-09-15
- Completion
- 2024-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Orelabrutinib | Small molecule | 100 mg | Oral |
| Subject | Orelabrutinib | Small molecule | 150 mg | Oral |
| Subject | Orelabrutinib | Small molecule | 200 mg | Oral |
| Background | Cytarabine | Small molecule | 50 mg | Intrathecal |
| Background | Dex | Unknown | 5 mg | Intrathecal |
| Background | MTX | Unknown | 12 mg | Intrathecal |
| Background | Pemetrexed | Small molecule | — | — |
| Background | fotemustine | Small molecule | 100 mg/m2 | Intravenous |