RCT of Intralesional Rituximab Injection Versus Involved Site Radiation Therapy in Ocular Adnexal… (NCT06064344) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
RCT of Intralesional Rituximab Injection Versus Involved Site Radiation Therapy in Ocular Adnexal MALT Lymphoma
108 participantsStarted 2023-10-07
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age between 18 to 75 years old.
✓. Meets the WHO diagnostic criteria for ocular adnexal MALT lymphoma, with a comprehensive diagnosis based on pathology (including pathological morphology, immunophenotype, and genetic testing), clinical manifestations, and biological characteristics:
✓. Clinical criteria: ①Extranodal lymphoma occurring in the ocular adnexa; ② Localized mass.
✓. Pathological criteria:
✓. Histopathology: Morphological features that recapitulate Peyer's patches, including: ①Lymphoepithelial 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).
✕. 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.
✕. Concurrent 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.
✕. Need for long-term use of local or systemic steroids.
✕. Patients already enrolled in other drug clinical trials.