A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With MCD Subtype Diffuse Large B-cell Lymphoma (BELIEVE-01)

February 5, 2024 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP Versus Placebo Plus R-CHOP in Treatment-naïve Patients With MCD Subtype DLBCL

The purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP regimen versus placebo with R-CHOP in the treatment of treatment-naïve patients with MCD subtype DLBCL.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233000
        • Recruiting
        • the First Affiliated Hospital of Bengbu Medical College
        • Contact:
          • Yanli Yang
      • Hefei, Anhui, China, 230031
        • Recruiting
        • Anhui Provincal Cancer Hospital
        • Contact:
          • Kaiyang Ding
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Hospital
        • Contact:
          • Hui Liu
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:
          • Yingyu Nan
      • Chongqing, Chongqing, China, 400000
        • Recruiting
        • The Southwest Hospital of Amu
        • Contact:
          • Shuangnian Xu
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
          • Jianzhen Shen
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Bing Xu
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Recruiting
        • Gansu Provincial Cancer Hospital
        • Contact:
          • Jie Cui
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Recruiting
        • The First People's Hospital of Foshan
        • Contact:
          • Ying Zhao
      • Guangzhou, Guangdong, China, 510280
        • Recruiting
        • ZhuJiang Hospital of Southern Medical University
        • Contact:
          • Shaojie Wu
      • Guangzhou, Guangdong, China, 510700
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • chunkang Chang
      • Guangzhou, Guangdong, China, 510180
        • Recruiting
        • Guangdong General Hospital
        • Contact:
          • Wenyu Li
      • Shenzhen, Guangdong, China, 518036
        • Recruiting
        • Peking University Shenzhen Hospital
        • Contact:
          • Hongyu Zhang
    • Guangzhou
      • Guandong, Guangzhou, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center Internal medicine department
        • Contact:
          • Qingqing Cai
    • Hebei
      • Baoding, Hebei, China, 050031
        • Recruiting
        • Affiliated Hospital of Hebei University
        • Contact:
          • hua xue
      • Shijia Zhuang, Hebei, China, 050000
        • Recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
          • jinhai Ren
    • Henan
      • Luoyang, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
          • Ling Qin
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Keshu Zhou
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Xinhua Wang
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Liang Huang
      • Wuhan, Hubei, China, 430023
        • Recruiting
        • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Liling Zhang
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Hui Zhou
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
          • Hongling Peng
      • Chenzhou, Hunan, China, 423099
        • Recruiting
        • Chenzhou First People's Hospital
        • Contact:
          • Xinquan Liang
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • The Affiliated Hospital of Nanjing University Medical School
        • Contact:
          • Jingyan Xu
      • Wuxi, Jiangsu, China, 214043
        • Recruiting
        • Wuxi People's Hospital
        • Contact:
          • Xin Zhou
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Fei Li
      • Nanchang, Jiangxi, China, 330001
        • Recruiting
        • Jiangxi Cancer Hospital
        • Contact:
          • Wuping Li
    • Liaoning
      • Dalian, Liaoning, China, 116023
        • Recruiting
        • The Second Hospital of Dalian Medical University
        • Contact:
          • Xiuhua Sun
      • Shenyang, Liaoning, China, 110002
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
          • xiaojing Yan
    • Shandong
      • Jinan, Shandong, China, 250000
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Ming Hou
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Provincial Hospital Affiliated to Shandong First Medical University
        • Contact:
          • Xin Wang
      • Qingdao, Shandong, China, 266400
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
          • Hongwei Xue
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
      • Shanghai, Shanghai, China, 200003
        • Active, not recruiting
        • Shanghai Changzheng Hospital
      • Shanghai, Shanghai, China, 201306
        • Active, not recruiting
        • Shanghai 6th People's Hospital
    • Shanxi
      • Xi'an, Shanxi, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Aili He
      • Xi'an, Shanxi, China, 710004
        • Active, not recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Active, not recruiting
        • West China Hospital Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Cancer Hospital
        • Contact:
          • Zhengzi Qian
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Recruiting
        • Affiliated Cancer Hospital of Xinjiang Medical University
        • Contact:
          • Shujuan Wen
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
        • Contact:
          • Jin Zhang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
          • Jie Jin
      • Shaoxing, Zhejiang, China, 312000
        • Recruiting
        • Shaoxing people's Hospital
        • Contact:
          • Jiaping Fu

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men and women between 18 and 80 years old
  2. Treatment-naive patients
  3. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) and CD20 positive.
  4. Provide FFPE slices of past or fresh tumor biopsy tissue.
  5. At least one measurable lesion.
  6. Lymphoma International Prognostic Score (IPI) ≥ 2.
  7. Ann Arbor stage II-IV, or stage I with bulky lesion (diameter > 7.5 cm）
  8. ECOG PS score of 0-2
  9. Subjects who in line with the testing standard of the clinical trial laboratory.
  10. Life expectancy ≥ 6 months.
  11. Able to provide signed written informed consent.

Exclusion Criteria:

  1. History of other active malignancies within 5 years of study entry, unless cured without evidence of relapse or metastasis
  2. Lymphoma involving the central nervous system or leptomeningeal metastasis.
  3. Transformed lymphoma, that is transformed from other types of lymphoma.
  4. Primary mediastinal large B-cell lymphoma.
  5. History of stroke or intracranial hemorrhage within 6 months before screening.
  6. Co-morbidity of uncontrolled or significant cardiovascular disease, significant impaired lung function, significant gastrointestinal abnormalities, uncontrolled infections (including HBV, HCV, HIV/AIDS and tuberculosis), or active autoimmune disease.
  7. Active bleeding within 2 months before screening, or a clear bleeding tendency determined by the investigator; a history of deep vein thrombosis or pulmonary embolism.
  8. Previous history of surgeries (major 4 weeks and minor 2 weeks prior screening) , organ transplant or hematopoietic stem cell transplantation, or progressive multifocal leukoencephalopathy (PML).
  9. Administer live and attenuated vaccines (semi-inactivated) within 28 days prior to first receiving the test drug.
  10. Planned stem cell transplant during the experimental treatment are excluded.
  11. Chemotherapy, immunotherapy, targeted therapy, radiotherapy, or traditional Chinese medicine with anti-tumor effects for the purpose of anti-tumor therapy within 4 weeks before starting to take the experimental drug. Excluding short-term emergency use of corticosteroids before treatment.
  12. Current diagnosis of any mental or cognitive impairment, drug abuse, or alcohol abuse.
  13. Pregnant, lactating women, or women at childbearing ages who will not use contraception during the study up to 12 months after the last dose of rituximab or 180 days after the last dose of study drug
  14. The last use of strong CYP3A inhibitor or strong CYP3A inducer is less than 5 halflivesfrom the first trial drug, or the drug or food with moderate and strong CYP3A inhibitory effect or strong CYP3A induction effect is planned to be taken at the same time during this study.
  15. Any serious medical condition that, in the investigator's opinion, would put the subject at unacceptable risk and/or would prevent the subject from signing the informed consent form. In the opinion of the investigator, the subject's participation in the study would be at unacceptable risk.

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: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Orelabrutinib+ R-CHOP
Participants will receive 150 mg of oral orelabrutinib once daily with R-CHOP on day 1 of each cycle (21 days).
Drug: Orelabrutinib + R-CHOP
The orelabrutinib is a white, round, uncoated tablet. The R-CHOP include rituximab, cyclophosphamide, doxorubicin, vincristine, and prednison.
Other Names:
  • ICP-022+ R-CHOP
Placebo Comparator: Placebo+ R-CHOP
Participants will receive 150 mg placebo once daily with R-CHOP on day 1 of each cycle (21 days).
Drug: Placebo + R-CHOP
The placebo is a white, round, uncoated tablet. The R-CHOP include rituximab, cyclophosphamide, doxorubicin, vincristine, and prednison.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: Up to 3 years and 9 months
Progression free survival (PFS) accessed by independent review committee (IRC)
Up to 3 years and 9 months
Complete response rate (CRR) by independent review committee (IRC)
Time Frame: Up to 3 years and 9 months
Complete response rate (CRR) at the completion of combination therapy accessed by independent review committee (IRC)
Up to 3 years and 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete response rate (CRR) by investigator
Time Frame: Up to 3 years and 9 months
Complete response rate (CRR) at the completion of combination therapy accessed by investigator
Up to 3 years and 9 months
Overall response rate (ORR) by independent review committee (IRC) and investigator
Time Frame: Up to 3 years and 9 months
Overall response rate (ORR) accessed by independent review committee (IRC) and investigator
Up to 3 years and 9 months
Overall response rate (ORR) at the completion of combination therapy by independent review committee (IRC) and investigator
Time Frame: Up to 3 years and 9 months
Overall response rate (ORR) at the completion of combination therapy accessed by independent review committee (IRC) and investigator
Up to 3 years and 9 months
Duration of Response (DOR)
Time Frame: Up to 3 years and 9 months
Duration of Response (DOR) accessed by independent review committee (IRC) and investigator
Up to 3 years and 9 months
Disease free survival (DFS) rate and event free survival (EFS) rate
Time Frame: Up to 2 years
2-year disease free survival (DFS) rate and 2-year event free survival (EFS) rate
Up to 2 years
Overall survival (OS) rate
Time Frame: Up to 2 years
2-year overall survival (OS) rate Accessed by independent review committee (IRC) and investigator
Up to 2 years
Occurrence of adverse events and serious adverse events according to CTCAE V5.0.
Time Frame: Up to 3 years and 9 months
The safety of Orelabrutinib measured by the occurrence of adverse events and serious adverse events according to CTCAE V5.0.
Up to 3 years and 9 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Weili Zhao, Ruijin Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICP-CL-00115

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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