Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma

Recruiting now · Phase 3

Conditions studied: Relapsed/Refractory Marginal Zone Lymphoma

In brief

Efficacy and Safety of Orelabrutinib Combined with Rituximab versus Lenalidomide Combined with Rituximab in Patients with Relapsed/Refractory Marginal Zone Lymphoma

Key facts

Study ID

NCT06082102

Run by

Beijing InnoCare Pharma Tech Co., Ltd.

People needed

324

Starts

2023-12-19

Expected to finish

2030-02-25

Last updated by the study team

2025-09-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years , either sex.
• Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).
• Prior systemic therapy including at least one anti-CD20 monoclonal antibody-containing regimen is required, with the following specifications:
• For combination therapies: Minimum of 2 completed treatment cycles For anti-CD20 monotherapy: Minimum of 4 administered doses Progression during treatment waives cycle/dose requirements
• Relapsed or refractory disease.
• At least 1 measurable lesion confirmed through enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI).
• ECOG performance status (PS) score of 0-2.

You may not qualify if…

• Administration of the specified anti-tumor therapies within 2 weeks prior to the first dose of the study treatment.
• Administration of any other investigational product within 4 weeks prior to the first dose of the study treatment, or concurrent participation in another clinical trial.(Excluding patients who have discontinued treatment and are in long-term follow-up).
• Prior treatment with any types of BTK inhibitor.
• Patients refractory to lenalidomide plus rituximab (R2 regimen). Refractoriness is defined as either: Failure to achieve at least partial response (PR) after completing an adequate R2 treatment course (≥2 cycles at standard doses), OR Disease progression during R2 therapy or within 6 months after the last dose.
• Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.

Where it is running

• The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)
• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Beijing Tongren Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
• Guangdong Provincial Hospital of Chinese Medicine — Guangzhou, Guangdong, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• Henan Provincial Peoples Hospital — Zhengzhou, Henan, China (enrolling)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)
• The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital） — Xi’an, Shanxi, China (enrolling)
• The First Affiliated Hospital of Bengbu Medical College — Bengbu, Auhui, China (enrolling)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (enrolling)
• The Second Hospital of Dalian Medical University — Dalian, Liaoning, China (enrolling)
• The first Hospital of China Medical University — Shenyang, Liaoning, China (enrolling)
• Yantai Yuhuangding Hospital — Yantai, Shandong, China (enrolling)
• Hunan Cancer Hospital — Changsha, Hunan, China
• The Affiliated Hospital Of Qingdao University — Qingdao, Shandong, China
• West China Hospital, Sichuan University — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

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