Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma
NCT ID: NCT06082102
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
324 participants
INTERVENTIONAL
2023-12-19
2030-02-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Orelabrutinib
Orelabrutinib
Orelabrutinib Tablets
Rituximab
Rituximab Injection
Comparator
Lenalidomide
Lenalidomide Capsules
Rituximab
Rituximab Injection
Interventions
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Orelabrutinib
Orelabrutinib Tablets
Rituximab
Rituximab Injection
Lenalidomide
Lenalidomide Capsules
Rituximab
Rituximab Injection
Eligibility Criteria
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Inclusion Criteria
2. Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).
3. 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
4. Relapsed or refractory disease.
5. At least 1 measurable lesion confirmed through enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI).
6. ECOG performance status (PS) score of 0-2.
Exclusion Criteria
2. 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).
3. Prior treatment with any types of BTK inhibitor.
4. 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.
5. Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.
18 Years
ALL
No
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Auhui, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Henan Provincial Peoples Hospital
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
The first Hospital of China Medical University
Shenyang, Liaoning, China
The Affiliated Hospital Of Qingdao University
Qingdao, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital）
Xi’an, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Yanli Yang
Role: primary
Lin Fu
Role: primary
Liang Wang
Role: primary
Huiqiang Huang
Role: primary
Xiping Dai
Role: primary
Keshu Zhou
Role: primary
Zunmin Zhu
Role: primary
Yu Hu
Role: primary
Yajun Li
Role: primary
Fei Li
Role: primary
Wuping Li
Role: primary
Xiaojing Yan
Role: primary
Xiaojing Yan
Role: primary
Xia Zhao
Role: primary
Xiaoxia Chu
Role: primary
Yan Yuan
Role: primary
Wanhong Zhao
Role: primary
Liqun Zou
Role: primary
Wenjuan Yu
Role: primary
Other Identifiers
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ICP-CL-00123
Identifier Type: -
Identifier Source: org_study_id
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