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.
Age between 18 to 75 years old.
Clinical criteria: ① Extranodal lymphoma occurring in the ocular adnexa; ② Localized mass.
Histopathology: Morphological features that recapitulate Peyer's patches, including: ① Lymphoepithelial lesions; ② Reactive follicles; ③ Marginal zone cells and/or monocytoid B cells; ④ Small lymphocyte-like cells; ⑤ Plasma cells; ⑥ Scattered transformed blasts (centroblast-like, immunoblast-like cells).
Immunophenotype: Tumor cells express B-cell-related antigens: SIgM+, CIg +/-, CD5-, CD10-, CD23-, cyclin DI, CD43 +/-, CD19, CD20, CD22, and CD79a positive.
Based on the TNM staging of ocular adnexal lymphoma, patients staged as T4 of ocular adnexal MALT lymphoma.
Patients who have previously received local or systemic radiation, chemotherapy, or drug treatment specifically for ocular adnexal MALT lymphoma.
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.
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.
Parallel
Rituximab
DrugIntralesional Rituximab Injection
Involved Site Radiation Therapy
RadiationInvolved Site Radiation Therapy
The cumulative occurrence rate of complications of grade ≥2 within 2 years after the start of treatment
Local control rate of ocular adnexal MALT lymphoma 2 years after the start of treatment
2-year Time-to-next-treatment rate
2-year overall survival rate
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This trial is not recruiting at the moment. You can still explore other options:
