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.

INTRODUCTION

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.

METHODS AND ANALYSIS

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.

ETHICS AND DISSEMINATION

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.

TRIAL REGISTRATION NUMBER

NCT06190301.