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RECRUITING
NCT05257018
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Official title: A Phase II Study of R-CDOP Combined With Intrathecal Methotrexate for Diffuse Large B-cell Lymphoma Patients With High-risk of Central Nervous System Relapse

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

83

Start Date

2022-02-26

Completion Date

2028-12-30

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

DRUG

R-CDOP+intrathecal MTX

R-CDOP+intrathecal MTX: * Rituximab 375 mg / m\^2,D1 * Cyclophosphamide 750 mg / m\^2,D2 * Doxorubicin Hydrochloride Liposome Injection 35mg / m\^2,D2 * Vincristine 1.4mg/m\^2 (dose capped at 2 mg),D2 * Prednisone 50 mg, bid D2-6 * Cycle1-5:Intrathecal MTX 12 mg + DXM 5 mg after chemotherapy (PK patients will be given 24 h after chemotherapy)

Locations (2)

Dongmei Ji

Shanghai, Shanghai Municipality, China

Cancer Hospital affilicaited to Xinjiang Medical University

Ürümqi, Xinjiang, China