An interventional study of Rituximab and Involved Site Radiation Therapy in Primary Ocular Adnexal MALT Lymphoma, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Treatment
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.
Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 159 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria
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.
Drug: Rituximab
Radiation: Involved Site Radiation Therapy
Intralesional Rituximab Injection
Involved Site Radiation Therapy
The cumulative occurrence rate of complications of grade ≥2 within 5 years after treatment commencement
Time frame: within 5 years after treatment commencement
overall response rate
Time frame: within 5 years after treatment commencement
progression-free survival
Time frame: within 5 years after treatment commencement
time to next treatment
Time frame: within 5 years after treatment commencement
overall survival
Time frame: within 5 years after treatment commencement
Plan to share: Yes
Supporting information: Study protocol, Sap, Csr, Analytic code
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Zhongshan Ophthalmic Center, Sun Yat-sen University