RCT of Intralesional Rituximab Injection Versus Involved Site Radiation Therapy in Ocular Adnexal… (NCT06064344) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
RCT of Intralesional Rituximab Injection Versus Involved Site Radiation Therapy in Ocular Adnexal MALT Lymphoma
108 participantsStarted 2023-10-07
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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).
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The cumulative occurrence rate of complications of grade ≥2 within 2 years after the start of treatment
Timeframe: 2 years after the start of treatment
Trial details
NCT IDNCT06064344
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
. 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.
Exclusion criteria
. 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.