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

NCT05257018 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2026-04-02

No results posted yet for this study

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.

Conditions

  • Diffuse Large B-cell Lymphoma

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）

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Dongmei Ji, doctor · Fudan University

  • Junning Cao, Doctor · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05257018 on ClinicalTrials.gov