RecruitingPhase 2NCT06700798

Orelabrutinib Combined With Rituximab Versus R-CVP in the Untreated MZL: A Randomized, Open Phase II Trial

A Randomized, Open-Label Phase II Clinical Study of Orelabrutinib Combined With Rituximab Versus R-CVP in the Treatment of Newly Diagnosed Marginal Zone Lymphoma (MZL).


Sponsor

Fei Li

Enrollment

90 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a randomized, open-label, multicenter, prospective clinical trial aimed at evaluating the efficacy and safety of orelabrutinib combined with rituximab for the previously untreat MZL


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment combinations for people with marginal zone lymphoma (a slow-growing type of blood cancer) who have never been treated before: a newer regimen using orelabrutinib plus rituximab versus the standard R-CVP chemotherapy combination. **You may be eligible if...** - You are 18 or older - You have been confirmed to have CD20-positive marginal zone lymphoma (a type of lymph node cancer) - You have not had any previous systemic treatment for this condition - Your organs are functioning well enough to handle treatment - You are willing to use contraception during and for 8 weeks after the study **You may NOT be eligible if...** - The cancer has spread to your central nervous system (brain or spinal cord) - You have another untreated cancer - You have serious heart problems or other significant medical conditions - You have been previously treated for this lymphoma 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

DRUGOrelabrutinib

150mg po

DRUGrituximab

375mg/m\^2, intravenous

DRUGCyclophosphamide

750mg/m\^2

DRUGVincristine

1.4mg/m\^2

DRUGPrednisone tablet

60mg/m\^2


Locations(1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

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NCT06700798


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