Zhongshan Ophthalmic Center, State Key Laboratory of Ophthalmology, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Sun Yat-Sen University, Guangzhou, Guangdong, China.
People's Hospital of Ningxia Hui Autonomous Region, Yinchuan, Ningxia, China.
BMJ Open. 2024 Nov 27;14(11):e084904. doi: 10.1136/bmjopen-2024-084904.
Involved site radiation therapy (ISRT) is a widely used treatment for primary ocular adnexal mucosa-associated lymphoid tissue (MALT) lymphoma with control rates over 85%; however, its complications could reach 30%-50%. Intralesional rituximab injection has shown promising results with remission rates between 65% and 100% and minimal complications. This study aimed to conduct a multicentre randomised controlled clinical trial to compare the safety and efficacy of intralesional rituximab injection versus ISRT on primary ocular adnexal MALT lymphoma.
This is a multicentre randomised controlled trial and will be conducted at eight ophthalmic departments and institutes in China. 108 patients with primary ocular adnexal MALT lymphoma will be enrolled and randomised to undergo intralesional rituximab injection or ISRT. Comprehensive examinations will be performed before and after the treatment. The primary outcome is the cumulative occurrence rate of complications of grade ≥2 within 5 years after treatment commencement. The main secondary outcome is overall response rate, and progression-free survival, time to next treatment and overall survival will also be compared between the groups.
Ethical approval has been obtained from the Ethics Committee of the Zhongshan Ophthalmic Center (ID: 2023KYPJ125-3; V.20240818) and the '5010 Plan' evaluation committee at Sun Yat-sen University, Guangzhou, China, and all subcentres. All the participants will be required to provide written informed consent. The results will be disseminated through scientific meetings and published in peer-reviewed journals.
NCT06190301.
累及部位放疗（ISRT）是治疗原发性眼附属器黏膜相关淋巴组织（MALT）淋巴瘤的常用方法，控制率超过 85%；然而，其并发症发生率可达 30%-50%。瘤内注射利妥昔单抗显示出有希望的结果，缓解率在 65%至 100%之间，且并发症极小。本研究旨在开展一项多中心随机对照临床试验，比较瘤内注射利妥昔单抗与 ISRT 治疗原发性眼附属器 MALT 淋巴瘤的安全性和疗效。
这是一项多中心随机对照临床试验，将在中国的 8 个眼科部门和研究所进行。将纳入 108 例原发性眼附属器 MALT 淋巴瘤患者，并随机分为瘤内注射利妥昔单抗组或 ISRT 组。治疗前后将进行全面检查。主要结局是治疗开始后 5 年内≥2 级并发症的累积发生率。主要次要结局是总缓解率，还将比较两组之间无进展生存率、下一次治疗时间和总生存率。
中山大学中山眼科中心伦理委员会（ID：2023KYPJ125-3；V.20240818）和广州中山大学“5010 计划”评估委员会已批准该研究，并获得了所有分中心的同意。所有参与者都将被要求提供书面知情同意书。研究结果将通过科学会议和同行评议期刊发表进行传播。
NCT06190301。
