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

Zhongshan Ophthalmic Center, Sun Yat-sen University0 sites108 target enrollmentOctober 7, 2023

ConditionsPrimary Ocular Adnexal MALT Lymphoma

InterventionsRituximab Involved Site Radiation Therapy

DrugsRituximab

Overview

Phase: Not Applicable
Intervention: Rituximab
Conditions: Primary Ocular Adnexal MALT Lymphoma
Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Enrollment: 108
Primary Endpoint: The cumulative occurrence rate of complications of grade ≥2 within 2 years after the start of treatment
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 7, 2023

End Date

October 6, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Responsible Party

Principal Investigator

Rong Lu

Professor, MD, PhD

Zhongshan Ophthalmic Center, Sun Yat-sen University

Eligibility Criteria

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: ① Extranodal lymphoma occurring in the ocular adnexa; ② Localized mass.
•Pathological criteria:
•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.
•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).
•Based on the TNM staging of ocular adnexal lymphoma, patients with stages T1-3 of ocular adnexal MALT lymphoma are included.
•Informed and signed informed consent.

Exclusion Criteria

•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/
•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.
•Pregnant or breastfeeding women.
•Serious systemic diseases: Advanced cardiac disease, kidney disease, respiratory diseases, or other malignant tumors, etc.
•Inability to understand the research content.

Arms & Interventions

Intralesional Rituximab Injection

Intervention: Rituximab

Involved Site Radiation Therapy

Intervention: Involved Site Radiation Therapy

Outcomes

Primary Outcomes

The cumulative occurrence rate of complications of grade ≥2 within 2 years after the start of treatment

Time Frame: 2 years after the start of treatment

Secondary Outcomes

Local control rate of ocular adnexal MALT lymphoma 2 years after the start of treatment(2 years after the start of treatment)
2-year Time-to-next-treatment rate(2 years after the start of treatment)
2-year overall survival rate(2 years after the start of treatment)