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

September 26, 2023 updated by: Rong Lu, Zhongshan Ophthalmic Center, Sun Yat-sen University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age between 18 to 75 years old.

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

Exclusion Criteria:

  1. Based on the TNM staging of ocular adnexal lymphoma, patients staged as T4 of ocular adnexal MALT lymphoma.
  2. Patients who have previously received local or systemic radiation, chemotherapy, or drug treatment specifically for ocular adnexal MALT lymphoma.
  3. 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.
  4. 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.
  5. 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.
  6. Need for long-term use of local or systemic steroids.
  7. Patients already enrolled in other drug clinical trials.
  8. Pregnant or breastfeeding women.
  9. Serious systemic diseases: Advanced cardiac disease, kidney disease, respiratory diseases, or other malignant tumors, etc.
  10. Inability to understand the research content.

If both eyes of a patient meet the inclusion criteria, the right eye will be selected for participation in the study, while the left eye will receive the same treatment, but its data will not be included in the research. Each patient can have only one eye participating in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intralesional Rituximab Injection
Drug: Rituximab
Intralesional Rituximab Injection
Active Comparator: Involved Site Radiation Therapy
Radiation: Involved Site Radiation Therapy
Involved Site Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years after the start of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Local control rate of ocular adnexal MALT lymphoma 2 years after the start of treatment
Time Frame: 2 years after the start of treatment
2 years after the start of treatment
2-year Time-to-next-treatment rate
Time Frame: 2 years after the start of treatment
2 years after the start of treatment
2-year overall survival rate
Time Frame: 2 years after the start of treatment
2 years after the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 7, 2023

Primary Completion (Estimated)

October 6, 2027

Study Completion (Estimated)

October 6, 2027

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023KYPJ125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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