RecruitingPhase 2NCT05257018

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

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


Sponsor

Fudan University

Enrollment

83 participants

Start Date

Feb 26, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment combination called R-CDOP plus spinal injections of a chemotherapy drug (methotrexate) for people newly diagnosed with an aggressive type of blood cancer called diffuse large B-cell lymphoma (DLBCL) who are at high risk of the cancer spreading to the brain or spinal cord. **You may be eligible if...** - You are between 18 and 75 years old - You have been newly diagnosed with DLBCL and have not received any treatment yet - Your cancer is considered high risk for spreading to the brain (based on a scoring system your doctor uses) - Your cancer involves certain body parts such as the testicles, breast, adrenal glands, kidneys, sinuses, or bone marrow - You are in generally good physical condition (able to carry out daily activities) - Your blood counts are within acceptable ranges **You may NOT be eligible if...** - You have already received treatment for your lymphoma - Your blood counts are too low - You have severe heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGR-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

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NCT05257018


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