Comparing Rituximab Injection and Radiation Therapy for Ocular Lymphoma

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

This study is testing whether an injection of Rituximab works as well as radiation therapy for treating a type of eye lymphoma, to see which option is safer and more effective for patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy, radiation, Rituximab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06190301 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the safety and efficacy of intralesional Rituximab injection against involved site radiation therapy for treating primary ocular adnexal MALT lymphoma. It is a multicenter, randomized, controlled study designed to provide high-level clinical evidence regarding treatment options for this condition. The goal is to identify a treatment that offers comparable therapeutic effects with fewer complications for patients. Participants will be monitored for outcomes related to both treatment methods.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with diagnosed ocular adnexal MALT lymphoma at stages T1-3 without intraconal compartment involvement.

Not a fit: Patients with advanced stages of ocular adnexal lymphoma (T4) or those with prior treatments for the condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a less invasive treatment option that maintains efficacy while reducing complications.

How similar studies have performed: While this approach is novel in the context of ocular adnexal MALT lymphoma, similar studies in other lymphoma types have shown promising results with Rituximab.

Eligibility criteria

Inclusion criteria

1. Age between 18 to 75 years old.
2. Ocular adnexal MALT lymphoma with a comprehensive diagnosis based on pathology, clinical manifestations, and biological characteristics according to the WHO classification of tumors of hematopoietic and lymphoid tissues.
3. Based on the TNM staging of ocular adnexal lymphoma, patients with stages T1-3 of ocular adnexal MALT lymphoma without involvement of intraconal compartment are included.
4. Willing to participate the trial and sign the informed consent form.

Exclusion criteria

1. Based on the TNM staging of ocular adnexal lymphoma (Table 1), patients staged as T2/T3 with involvement of intraconal compartment and patients staged as T4.
2. Patients who have previously received local or systemic radiation, chemotherapy, or drug treatment specifically for ocular adnexal MALT lymphoma.
3. Presence of cataract and is anticipated to require surgical treatment within a certain period after enrollment; existing cataract affects visual field testing and fundoscopic examination; vision affected by cataract is \<20/40.
4. In addition to the need for treatment of ocular adnexal MALT lymphoma, there is a requirement for other ocular procedures (e.g., full-thickness corneal transplant or retinal surgery) or an anticipated need for another emergent ocular surgery.
5. Complicated with other ocular diseases: including corneal abnormalities or existing corneal infections, iridocorneal endothelial syndrome, anterior segment dysgenesis, true microphthalmos, uveitis, glaucoma, ocular trauma, and retinal disorders such as central retinal vein occlusion, central retinal artery occlusion, retinal detachment, etc.
6. The statue of HBV or HIV infection.
7. Need for long-term use of local or systemic steroids.
8. Patients already enrolled in other drug clinical trials.
9. Pregnant or breastfeeding women.
10. Serious systemic diseases: advanced cardiac disease, kidney disease, respiratory disease, or other malignant tumors, etc.
11. Inability to understand the research content.

If both eyes of a patient meet the inclusion criteria, the right eye will be selected for participation in the study, while the left eye will receive the same treatment, but its data will not be included in this research. Each patient can have only one eye participating in the study. If both eyes of a patient meet the inclusion criteria and the patient is randomized to the ISRT group, the eye with the larger lesion or with more symptomatic disease is treated first, and in the case of well tolerability, the other eye is irradiated.

Where this trial is running

Guangzhou, Guangdong

• Zhongshan Ophthalmic Center, Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Rong Lu

Conditions Primary Ocular Adnexal MALT Lymphoma