RCT of Intralesional Rituximab Injection Versus Involved Site Radiation Therapy in Ocular Adnexal MALT Lymphoma
- Sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- Study ID
- NCT06064344
- Status
- Not Yet 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 — DRUGIntralesional Rituximab Injection
- Involved Site Radiation Therapy — RADIATIONInvolved 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
- Oct 7, 2023
- Status verified
- Sep 2023
- Primary completion
- Oct 6, 2027
- Completion
- Oct 6, 2027
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 2 years after the start of treatment [ Time Frame: 2 years after the start of treatment ]