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

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400084873

Enrollment

Unknown

Registered

2024-05-27

Start date

2023-10-25

Completion date

Unknown

Last updated

2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Ocular Adnexal MALT Lymphoma

Interventions

Experimental:Intralesional Rituximab Injection

Control:Involved Site Radiation Therapy

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: a. Age between 18 to 75 years old. b. 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: 1. Clinical criteria: # Extranodal lymphoma occurring in the ocular adnexa; # Localized mass. 2. Pathological criteria: 1) Histopathology: Morphological features that recapitulate Peyer's patches, including: # Lymphoepithelial lesions; # Reactive follicles; # Marginal zone cells and/ or monocytoid B cells; # Small lymphocyte-like cells; # Plasma cells; # Scattered transformed blasts (centroblast-like, immunoblast-like cells). 2) Immunophenotype: Tumor cells express B-cell-related antigens: SIgM+, CIg +/-, CD5-, CD10-, CD23-, cyclin DI, CD43 +/-, CD19, CD20, CD22, and CD79a positive. 3) Genetic features: Absence of BCL-1 and BCL-2 gene rearrangements, presence of IgH/L gene rearrangements; possible +3 and t(11, 18)(q21, q21). c. Based on the TNM staging of ocular adnexal lymphoma, patients with stages T1-3 of ocular adnexal MALT lymphoma are included. d. Informed and signed informed consent.

Exclusion criteria

Exclusion criteria: a. Based on the TNM staging of ocular adnexal lymphoma, patients staged as T4 of ocular adnexal MALT lymphoma. b. Patients who have previously received local or systemic radiation, chemotherapy, or drug treatment specifically for ocular adnexal MALT lymphoma. c. 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. d. 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. e. 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. f. Need for long-term use of local or systemic steroids. g. Patients already enrolled in other drug clinical trials. h. Pregnant or breastfeeding women. i. Serious systemic diseases: Advanced cardiac disease, kidney disease, respiratory diseases, or other malignant tumors, etc. j. Inability to understand the research content.

Design outcomes

Primary

Measure	Time frame
The cumulative occurrence rate of complications of grade =2 within 2 years after treatment commencement;	—

Secondary

Measure	Time frame
Overall response rate;Progression-free survival;Time to next treatment;Overall survival;	—

Countries

China

Contacts

Public ContactRong Lu

Zhongshan Ophthalmic Center, Sun Yat-sen University

lurong@gzzoc.com+86 138 2645 6581

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026