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

Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study ID
NCT06190301
Status
Recruiting
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Conditions

  • Primary Ocular Adnexal MALT Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Intralesional Rituximab Injection
  • Involved Site Radiation Therapy — RADIATION
    Involved Site Radiation Therapy

Study Details

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.

Key Dates

Start date
Dec 20, 2023
Status verified
Apr 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intralesional Rituximab Injection
  • Active Comparator: Involved Site Radiation Therapy

Primary Outcome Measure

The cumulative occurrence rate of complications of grade ≥2 within 5 years after treatment commencement [ Time Frame: within 5 years after treatment commencement ]

Central Contacts