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drugset / Trial / NCT05036577

A Dose-escalating Pilot Study of Orelabrutinib for Newly-diagnosed PCNSL

NCT05036577 ↗

Phase 1 Active not recruiting 15 enrolled Huashan Hospital
NaSingle-groupOpen-labelTreatment

Summary

This is a single arm, single center, open label pilot study of Orelabrutinib combined with Rituximab, high-dose (HD) Methotrexate and Dexamethasone in newly-diagnosed primary central nervous system lymphpoma (PCNSL). The purpose is to evaluate the safety and to find the optimal dose of Orelabrutinib and Methotrexate in this combination treatment for newly-diagnosed PCNSL patients.

Timeline

Start
2021-10-10
Primary completion
2023-12-31
Completion
2025-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Methotrexate Small molecule 3.5 g Intravenous
Subject Methotrexate Small molecule 5 g Intravenous
Subject Orelabrutinib Small molecule 150 mg Oral
Subject Orelabrutinib Small molecule 200 mg Oral
Background Dexamethasone Small molecule 10 mg Intravenous
Background Dexamethasone Small molecule 15 mg Intravenous
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications

primary central nervous system lymphoma