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

Not Applicable
Recruiting
Conditions
Primary Ocular Adnexal MALT Lymphoma
Interventions
Radiation: Involved Site Radiation Therapy
Registration Number
NCT06190301
Lead Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
108
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Involved Site Radiation TherapyInvolved Site Radiation Therapy-
Intralesional Rituximab InjectionRituximab-
Primary Outcome Measures
NameTimeMethod
The cumulative occurrence rate of complications of grade ≥2 within 5 years after treatment commencementwithin 5 years after treatment commencement
Secondary Outcome Measures
NameTimeMethod
overall survivalwithin 5 years after treatment commencement
time to next treatmentwithin 5 years after treatment commencement
progression-free survivalwithin 5 years after treatment commencement
overall response ratewithin 5 years after treatment commencement

Trial Locations

Locations (2)

Zhongshan Ophthalmic Center, Sun Yat-sen University

🇨🇳

Guangzhou, Guangdong, China

First Affiliated Hospital of Zhengzhou University

🇨🇳

Zhengzhou, China

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