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

Not Applicable

Recruiting

• Conditions: Primary Ocular Adnexal MALT Lymphoma

• Registration Number: NCT06190301
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-18
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria<br><br> 1. Age between 18 to 75 years old.<br><br> 2. Ocular adnexal MALT lymphoma with a comprehensive diagnosis based on pathology,<br> clinical manifestations, and biological characteristics according to the WHO<br> classification of tumors of hematopoietic and lymphoid tissues.<br><br> 3. Based on the TNM staging of ocular adnexal lymphoma, patients with stages T1-3 of<br> ocular adnexal MALT lymphoma without involvement of intraconal compartment are<br> included.<br><br> 4. Willing to participate the trial and sign the informed consent form.<br><br>Exclusion criteria<br><br> 1. Based on the TNM staging of ocular adnexal lymphoma (Table 1), patients staged as<br> T2/T3 with involvement of intraconal compartment and patients staged as T4.<br><br> 2. Patients who have previously received local or systemic radiation, chemotherapy, or<br> drug treatment specifically for ocular adnexal MALT lymphoma.<br><br> 3. Presence of cataract and is anticipated to require surgical treatment within a<br> certain period after enrollment; existing cataract affects visual field testing and<br> fundoscopic examination; vision affected by cataract is <20/40.<br><br> 4. In addition to the need for treatment of ocular adnexal MALT lymphoma, there is a<br> requirement for other ocular procedures (e.g., full-thickness corneal transplant or<br> retinal surgery) or an anticipated need for another emergent ocular surgery.<br><br> 5. Complicated with other ocular diseases: including corneal abnormalities or existing<br> corneal infections, iridocorneal endothelial syndrome, anterior segment dysgenesis,<br> true microphthalmos, uveitis, glaucoma, ocular trauma, and retinal disorders such as<br> central retinal vein occlusion, central retinal artery occlusion, retinal<br> detachment, etc.<br><br> 6. The statue of HBV or HIV infection.<br><br> 7. Need for long-term use of local or systemic steroids.<br><br> 8. Patients already enrolled in other drug clinical trials.<br><br> 9. Pregnant or breastfeeding women.<br><br> 10. Serious systemic diseases: advanced cardiac disease, kidney disease, respiratory<br> disease, or other malignant tumors, etc.<br><br> 11. Inability to understand the research content.<br><br>If both eyes of a patient meet the inclusion criteria, the right eye will be selected for<br>participation in the study, while the left eye will receive the same treatment, but its<br>data will not be included in this research. Each patient can have only one eye<br>participating in the study. If both eyes of a patient meet the inclusion criteria and the<br>patient is randomized to the ISRT group, the eye with the larger lesion or with more<br>symptomatic disease is treated first, and in the case of well tolerability, the other eye<br>is irradiated.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The cumulative occurrence rate of complications of grade =2 within 5 years after treatment commencement

Secondary Outcome Measures

Name	Time	Method
overall response rate;progression-free survival;time to next treatment;overall survival