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

NCT04831658

Phase 1/2 Unknown 40 enrolled Mingzhi Zhang
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

EvaluationDrugModalityDoseRoute
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