A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma

March 26, 2026 updated by: Beijing InnoCare Pharma Tech Co., Ltd.
To evaluate the efficacy of orelabrutinib combined with R-CHOP vs. R-CHOP alone in the treatment of treatment-naїve mantle cell lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

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 Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230009
        • Anhui Province Cancer Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100143
        • Beijing Cancer Hospital
    • Changsha
      • Hunan, Changsha, China, 410013
        • Tumor in Hunan Province
    • Fujian
      • Xiamen, Fujian, China, 361003
        • The first affiliated hospital of xiamen university
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center
      • Guangzhou, Guangdong, China, 510180
        • Guangzhou First People's Hospital
    • Hebei
      • Shijiazhuang, Hebei, China, 50011
        • The Fourth Hospital of Hebei Medical University
    • Henan
      • Zhengzhou, Henan, China, 450052
        • The first affiliated hospital of Zhengzhou university
      • Zhengzhou, Henan, China, 450008
        • Henan Tumor Hospital
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Union Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University
    • Jiangxi
      • Nanchang, Jiangxi, China, 3300008
        • The First Affiliated Hospital of NanChang University
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Liaojing
      • Shenyang, Liaojing, China, 110001
        • The First Hospital of China Medical University
    • Nanning
      • Guangxi, Nanning, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University
    • Shandong
      • Jinan, Shandong, China, 250021
        • Shandong Provincial Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital,Sichuan University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300060
        • Tianjin cancer hospital
      • Tianjin, Tianjin Municipality, China, 300052
        • Hospital of Hematology, Chinese Academy of Medical Sciences
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310003
        • he First Affiliated Hospital of Zhengjiang University

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

60 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 65 < age <80, or 60 ≤ age ≤65 and is ineligible for autologous stem cell transplantation as assessed by the investigator
  2. Histopathological confirmed MCL and either expression of cyclin D1 or t (11;14) chromosomal translocation (in association with CD20). The verification will be based on central review of the local pathology report.
  3. No previous systemic treatment for MCL.
  4. ECOG physical strength score is 0-2.
  5. Expected survival time >6 months.
  6. Voluntary written informed consent prior to screening.

Exclusion Criteria:

  1. Uncontrolled or significant cardiovascular diseases
  2. History of stroke or intracranial hemorrhage within 6 months before first administration of study treatment.
  3. Any mental or cognitive impairments which may limit the subject 's understanding and execution of informed consent as well as study compliance;
  4. Pregnant or breastfeeding women and those who do not agree to take contraceptive measures.
  5. Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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
Experimental: the experimental group
Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
Drug: Orelabrutinib and R-CHOP
Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
Experimental: The control group
R-CHOP
Drug: R-CHOP
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: Up to 6 years
To evaluate the Progression-free Survival (PFS) by the Independent Review Committee (IRC) according to the 2014 International Working Group Criteria for Non-Hodgkin Lymphoma (iwNHL).
Up to 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: Up to 6 years
Objective Response Rate
Up to 6 years
CRR
Time Frame: Up to 6 years
Complete Response Rate
Up to 6 years
OS
Time Frame: Up to 6 years
Overall Survival
Up to 6 years

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 22, 2021

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (Actual)

September 21, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICP-CL-00113

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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