Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma
A Randomized, Controlled, Open-label, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Orelabrutinib Plus Rituximab Versus Lenalidomide Plus Rituximab in Relapsed/Refractory Marginal Zone Lymphoma
1 other identifier
interventional
324
1 country
19
Brief Summary
Efficacy and Safety of Orelabrutinib Combined with Rituximab versus Lenalidomide Combined with Rituximab in Patients with Relapsed/Refractory Marginal Zone Lymphoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2023
Longer than P75 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2023
CompletedFirst Posted
Study publicly available on registry
October 13, 2023
CompletedStudy Start
First participant enrolled
December 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 25, 2030
September 15, 2025
September 1, 2025
4.7 years
October 8, 2023
September 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
IRC-assessed PFS
Through study completion, an average of 5 year.
Study Arms (2)
Orelabrutinib
EXPERIMENTALComparator
ACTIVE COMPARATORInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Auhui, 233000, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510055, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Henan Provincial Peoples Hospital
Zhengzhou, Henan, 450003, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116023, China
The first Hospital of China Medical University
Shenyang, Liaoning, 110002, China
The Affiliated Hospital Of Qingdao University
Qingdao, Shandong, 266000, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200040, China
The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital）
Xi’an, Shanxi, 710004, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2023
First Posted
October 13, 2023
Study Start
December 19, 2023
Primary Completion (Estimated)
August 31, 2028
Study Completion (Estimated)
February 25, 2030
Last Updated
September 15, 2025
Record last verified: 2025-09