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RecruitingNCT06190301Updated Apr 20, 2026

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

An interventional study of Rituximab and Involved Site Radiation Therapy in Primary Ocular Adnexal MALT Lymphoma, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2023; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Primary Ocular Adnexal MALT Lymphoma
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In context

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 159 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age between 18 to 75 years old.
  2. 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.
  3. 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.
  4. Willing to participate the trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria

  1. 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.
  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. 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.
  6. The statue of HBV or HIV infection.
  7. Need for long-term use of local or systemic steroids.
  8. Patients already enrolled in other drug clinical trials.
  9. Pregnant or breastfeeding women.
  10. Serious systemic diseases: advanced cardiac disease, kidney disease, respiratory disease, or other malignant tumors, etc.
  11. 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 this research. Each patient can have only one eye participating in the study. If both eyes of a patient meet the inclusion criteria and the patient is randomized to the ISRT group, the eye with the larger lesion or with more symptomatic disease is treated first, and in the case of well tolerability, the other eye is irradiated.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
108 participants (estimated)

Study arms

  • Experimental
    Intralesional Rituximab Injection

    Drug: Rituximab

  • Active comparator
    Involved Site Radiation Therapy

    Radiation: Involved Site Radiation Therapy

Interventions

  • DrugRituximab

    Intralesional Rituximab Injection

  • RadiationInvolved Site Radiation Therapy

    Involved Site Radiation Therapy

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What researchers measure

Primary outcomes

  1. The cumulative occurrence rate of complications of grade ≥2 within 5 years after treatment commencement

    Time frame: within 5 years after treatment commencement

Secondary outcomes

  1. overall response rate

    Time frame: within 5 years after treatment commencement

  2. progression-free survival

    Time frame: within 5 years after treatment commencement

  3. time to next treatment

    Time frame: within 5 years after treatment commencement

  4. overall survival

    Time frame: within 5 years after treatment commencement

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Study locations

1 of 1 sites recruiting
  • Zhongshan Ophthalmic Center, Sun Yat-Sen University
    Guangzhou, Guangdong 510060, China
    Recruiting
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References and documents

Publications

  • 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. PubMed 39608989 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Csr, Analytic code

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06190301
Lead sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Responsible party
Rong Lu (Professor, MD, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University) — Principal investigator
First posted
Jan 5, 2024
Start date
Dec 20, 2023
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Apr 20, 2026

Study contacts

Rong Lu
Contact
lurong@gzzoc.com
+8613826456581

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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