Clinical Trial

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

Study acronym: ORMD2021
Active, Not Recruiting Phase 1
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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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-08-31; most recent amendment 2024-10-17.
Status change: Recruiting → Active, Not Recruiting 2023-10-30
Status change: Not Yet Recruiting → Recruiting 2021-10-17
Trial Details
NCT Number NCT05036577
Lead Sponsor Huashan Hospital
Conditions Primary Central Nervous System Lymphoma
Enrollment 15 participants
Start Date 2021-10-10
Primary Completion 2023-12-31 (estimated)
Study Completion 2025-09-30 (estimated)
Updated on ClinicalTrials.gov 2024-10-18