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

Recruiting at1 trial location

Overseen by Junning Cao, Doctor

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Fudan University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Dongmei Ji, doctor

Principal Investigator

Fudan University

Junning Cao, Doctor

Principal Investigator

Fudan University

Eligibility Criteria

Inclusion Criteria

Age range from 18 to 75 years;

ECOG performance status: 0-2;

CNS-IPI 4-6;

Treatment Details

Interventions

• R-CDOP+intrathecal MTX (Anti-cancer agent)

Participant Groups

Group I: R-CDOP+intrathecal MTX Experimental Treatment 1 Intervention

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 24h after chemotherapy）

Who Is Running the Clinical Trial?

Fudan University

Lead Sponsor

Trials

1,280

Recruited

1,719,000+

James Burke

Fudan University

Chief Medical Officer since 2024

MD from UCSF

Ping Zhang

Fudan University

Chief Executive Officer

B.S. in Polymer Science from Fudan University, MBA in Finance from the University of Chicago Booth School of Business