drugset / Trial / NCT06901999

Methotrexate or Thiotepa Combined With R-CHOP and Orelabrutinib in CNSL Patients

NCT06901999

Phase 2 Not yet recruiting 23 enrolled Ruijin Hospital
NaSingle-groupOpen-labelTreatment

Summary

This study is designed as an open-label, prospective, single-arm, single-center trial aimed at evaluating the efficacy and safety of MTX or Thiotepa combined with Orelabrutinib and standard chemotherapy regimens in the treatment of DLBCL patients with central nervous system involvement.

Timeline

Start
2025-04
Primary completion
2026-11
Completion
2028-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 750 mg/m2
Subject Doxorubicin Other / unclassified 50 mg/m2
Subject Methotrexate Small molecule 3.5 g
Subject Orelabrutinib Small molecule 150 mg Oral
Subject Prednisone Other / unclassified 100 mg
Subject Rituximab Monoclonal antibody 375 mg/m2
Subject Thiotepa Other / unclassified 40 mg/m2
Subject Vincristine Small molecule 1.4 mg/m2