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

NCT06064344 | Not Yet Recruiting DMC

• 1 other identifier: 2023KYPJ125
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Ocular Adnexal MALT Lymphoma

Outcome Measures

Primary Outcomes (1)

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

  2 years after the start of treatment

Secondary Outcomes (3)

• 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

Study Arms (2)

Intralesional Rituximab Injection

EXPERIMENTAL

Drug: Rituximab

Involved Site Radiation Therapy

ACTIVE COMPARATOR

Radiation: Involved Site Radiation Therapy

Interventions

Rituximab DRUG

Intralesional Rituximab Injection

Intralesional Rituximab Injection

Involved Site Radiation Therapy RADIATION

Involved Site Radiation Therapy

Involved Site Radiation Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
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• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

MeSH Terms

Interventions

Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: October 7, 2023
• Primary Completion (Estimated): October 6, 2027
• Study Completion (Estimated): October 6, 2027
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share