NCT06190301招募中不适用
Safety and Efficacy of Intralesional Rituximab Injection Versus Involved Site Radiation Therapy in Primary Ocular Adnexal MALT Lymphoma: a Multicenter Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- The cumulative occurrence rate of complications of grade ≥2 within 5 years after treatment commencement
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 T
- •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/
- •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.
- •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.
研究组 & 干预措施
Involved Site Radiation Therapy
Active Comparator
干预措施: Involved Site Radiation Therapy (Radiation)
Intralesional Rituximab Injection
Experimental
干预措施: Rituximab (Drug)
结局指标
主要结局
The cumulative occurrence rate of complications of grade ≥2 within 5 years after treatment commencement
时间窗: within 5 years after treatment commencement
次要结局
- overall survival(within 5 years after treatment commencement)
- time to next treatment(within 5 years after treatment commencement)
- progression-free survival(within 5 years after treatment commencement)
- overall response rate(within 5 years after treatment commencement)
研究者
Rong Lu
Professor, MD, PhD
Zhongshan Ophthalmic Center, Sun Yat-sen University
研究点 (1)
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