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

September 12, 2025 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

324

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Auhui
      • Bengbu, Auhui, China, 233000
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
          • Yanli Yang
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital, Capital Medical University
        • Contact:
          • Lin Fu
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Beijing Tongren Hospital, Capital Medical University
        • Contact:
          • Liang Wang
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Guangdong Provincial Hospital of Chinese Medicine
        • Contact:
          • Xiping Dai
      • Guangzhou, Guangdong, China, 510055
        • Recruiting
        • Sun yat-sen University Cancer Center
        • Contact:
          • Huiqiang Huang
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Keshu Zhou
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Provincial Peoples Hospital
        • Contact:
          • zunmin Zhu
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Contact:
          • Yu Hu
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Yajun Li
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Fei Li
      • Nanchang, Jiangxi, China, 330029
        • Recruiting
        • Jiangxi Cancer Hospital
        • Contact:
          • Wuping Li
    • Liaoning
      • Dalian, Liaoning, China, 116023
        • Recruiting
        • The Second Hospital of Dalian Medical University
        • Contact:
          • xiaojing Yan
      • Shenyang, Liaoning, China, 110002
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
          • xiaojing Yan
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Not yet recruiting
        • The affiliated hospital of Qingdao university
        • Contact:
          • Xia Zhao
      • Yantai, Shandong, China, 264099
        • Recruiting
        • Yantai Yuhuangding Hospital
        • Contact:
          • Xiaoxia Chu
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
          • Yan Yuan
    • Shanxi
      • Xi’an, Shanxi, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital)
        • Contact:
          • Wanhong Zhao
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • West China Hospital, Sichuan University
        • Contact:
          • Liqun Zou
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
          • Wenjuan Yu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 18 years , either sex.
  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:

  1. Administration of the specified anti-tumor therapies within 2 weeks prior to the first dose of the study treatment.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Comparator
Drug: Lenalidomide
Lenalidomide Capsules
Drug: Rituximab
Rituximab Injection
Experimental: Orelabrutinib
Drug: Orelabrutinib
Orelabrutinib Tablets
Drug: Rituximab
Rituximab Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
IRC-assessed PFS
Time Frame: Through study completion, an average of 5 year.
Through study completion, an average of 5 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2023

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

February 25, 2030

Study Registration Dates

First Submitted

October 8, 2023

First Submitted That Met QC Criteria

October 8, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 12, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICP-CL-00123

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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