RCT of Intralesional Rituximab Injection Versus Involved Site Radiation Therapy in Ocular Adnexal MALT Lymphoma

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Rituximab
  • Involved Site Radiation Therapy

Treatment groups

108 Participants
are divided into 2 treatment groups

Locations

This trial has no locations