drugset / Trial / NCT05257018

R-CDOP Combined With Intrathecal Methotrexate for DLBCL Patients With High-risk of CNS Relapse

NCT05257018 ↗

Phase 2 Recruiting 83 enrolled Fudan University
NaSingle-groupOpen-labelTreatment

Summary

This is a double-center, single-arm, phase 2 study to evaluate the efficacy and safety of R-CDOP regimen combined with intrathecal methotrexate in chemo-naive diffuse large B-cell lymphoma patients with high-risk of CNS relapse.

Timeline

Start
2022-02-26
Primary completion
2026-12-30
Completion
2028-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 750 mg/m2 —
Subject Doxorubicin Other / unclassified 35 mg/m2 —
Subject Methotrexate Small molecule 12 mg Intrathecal
Subject Prednisone Other / unclassified 50 mg —
Subject Rituximab Monoclonal antibody 375 mg/m2 —
Subject Vincristine Small molecule 1.4 mg/m2 —
Background DXM Unknown 5 mg —