RecruitingNot ApplicableNCT06190301

RCT on Intralesional Rituximab Injection Versus ISRT in Ocular Adnexal MALT Lymphoma

Safety and Efficacy of Intralesional Rituximab Injection Versus Involved Site Radiation Therapy in Primary Ocular Adnexal MALT Lymphoma: a Multicenter Randomized Controlled Trial


Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Enrollment

108 participants

Start Date

Dec 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This project proposes to establish a prospective, multicenter, randomized, controlled clinical study to compare the safety and efficacy of Intralesional Rituximab Injection versus Involved Site Radiation Therapy for the treatment of primary ocular adnexal MALT lymphoma. The aim is to provide high-level clinical evidence for the treatment of ocular adnexal MALT lymphoma and to offer patients treatment options that have fewer complications and comparable therapeutic effects.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for a slow-growing lymphoma found in the tissues around the eye (ocular adnexal MALT lymphoma): a direct injection of rituximab (a targeted antibody) into the affected area versus targeted radiation therapy. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with ocular adnexal MALT lymphoma (confirmed by biopsy) - Your disease is classified as early-to-intermediate stage (T1–T3 without deep orbital involvement) - You have not received any prior treatment specifically for this lymphoma **You may NOT be eligible if...** - Your lymphoma has spread deeply into the eye socket or is classified as T4 stage - You have a cataract that significantly affects vision or requires surgery - You need other eye surgery - You have certain other active eye conditions (corneal disease, glaucoma, etc.) 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

DRUGRituximab

Intralesional Rituximab Injection

RADIATIONInvolved Site Radiation Therapy

Involved Site Radiation Therapy


Locations(1)

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, China

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NCT06190301