RCT on Intralesional Rituximab Injection Versus ISRT in Ocular Adnexal MALT Lymphoma

NCT06190301 | Recruiting DMC

• 1 other identifier: 2023KYPJ125-4
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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 5 years after treatment commencement

  within 5 years after treatment commencement

Secondary Outcomes (4)

• overall response rate

  within 5 years after treatment commencement

• progression-free survival

  within 5 years after treatment commencement

• time to next treatment

  within 5 years after treatment commencement

• overall survival

  within 5 years after treatment commencement

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.
• Ocular adnexal MALT lymphoma with a comprehensive diagnosis based on pathology, clinical manifestations, and biological characteristics according to the WHO classification of tumors of hematopoietic and lymphoid tissues.
• Based on the TNM staging of ocular adnexal lymphoma, patients with stages T1-3 of ocular adnexal MALT lymphoma without involvement of intraconal compartment are included.
• Willing to participate the trial and sign the informed consent form.

You may not qualify if:

• Based on the TNM staging of ocular adnexal lymphoma (Table 1), patients staged as T2/T3 with involvement of intraconal compartment and patients staged as T4.
• 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.
• Complicated with 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.
• The statue of HBV or HIV infection.
• 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 disease, or other malignant tumors, etc.
• Inability to understand the research content.

Sponsors & Collaborators

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

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (1)

• Liu Y, Gao Y, Jin L, Li Q, Wang X, Wu Y, Zhou J, Liu W, Wang L, Dong Y, Zheng Y, Chen L, Li J, Su S, Tang J, Wang Y, Huang W, Cheng C, Li C, An N, Tan J, Chen H, Guo H, Wang Y, Zhou Q, Han F, Liu H, Zhu Y, Lu R. Safety and efficacy of intralesional rituximab injection versus involved site radiation therapy in primary ocular adnexal MALT lymphoma: study protocol for a multicentre randomised controlled trial. BMJ Open. 2024 Nov 27;14(11):e084904. doi: 10.1136/bmjopen-2024-084904.

  PMID: 39608989 DERIVED

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

Central Study Contacts

Rong Lu

CONTACT

+8613826456581; lurong@gzzoc.com

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: December 18, 2023
• First Posted: January 5, 2024
• Study Start: December 20, 2023
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Access Criteria: Available upon reasonable request

Locations

CN (1)