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Diffuse Large B Cell Lymphoma (DLBCL)Phase 3BELIEVE-01NCT05234684

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

A Phase 3 study testing Orelabrutinib + R-CHOP in people with Diffuse Large B Cell Lymphoma (DLBCL), run by Beijing InnoCare Pharma Tech Co., Ltd. at 44 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diffuse Large B Cell Lymphoma (DLBCL)
What is being tested?
Orelabrutinib + R-CHOP
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
44 sitesChina
Study dates
2 Nov 2022to 30 Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • History of other active malignancies within 5 years of study entry, unless cured without evidence of relapse or metastasis
  • Lymphoma involving the central nervous system or leptomeningeal metastasis.
  • Transformed lymphoma, that is transformed from other types of lymphoma.
  • Primary mediastinal large B-cell lymphoma.
  • History of stroke or intracranial hemorrhage within 6 months before screening.
  • 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.
Show all 15Show fewer
  • 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.
  • 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).
  • Administer live and attenuated vaccines (semi-inactivated) within 28 days prior to first receiving the test drug.
  • Planned stem cell transplant during the experimental treatment are excluded.
  • 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.
  • Current diagnosis of any mental or cognitive impairment, drug abuse, or alcohol abuse.
  • 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
  • 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.
  • 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.

Trial locations and contacts

44 sites in 1 country.

Weili Zhao contact

+86 021-64370045

zwl_trial@163.com

44 sites in 1 country

China44 sites, 40 recruiting

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, 050031

    Hua Xue

    Recruiting

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

    Hui Liu

    Recruiting

  • The first affiliated hospital of bengbu medical college

    Bengbu, Anhui, 233000

    Yanli Yang

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

    Hongling Peng

    Recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Hui Zhou

    Recruiting

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610000

    Active, not recruiting

  • Chenzhou first people's Hospital

    Chenzhou, Hunan, 423099

    Xinquan Liang

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400000

    Yingyu Nan

    Recruiting

  • The Southwest Hospital of AMU

    Chongqing, Chongqing Municipality, 400000

    Shuangnian Xu

    Recruiting

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116023

    Xiuhua Sun

    Recruiting

  • The First People's Hospital of Foshan

    Foshan, Guangdong, 528000

    Ying Zhao

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Jianzhen Shen

    Recruiting

  • Sun Yat-sen University Cancer Center Internal medicine department

    Guandong, Guangzhou, 510060

    Qingqing Cai

    Recruiting

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510180

    Wenyu Li

    Recruiting

  • ZhuJiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

    Shaojie Wu

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510700

    Chunkang Chang

    Recruiting

  • The first affiliated Hospital Zhejiang University School Of Medicine

    Hangzhou, Zhejiang, 310003

    Jie Jin

    Recruiting

  • Sir Run Run Shaw Hospital Zhejiang University School Of Medicine

    Hangzhou, Zhejiang, 310016

    Jin Zhang

    Recruiting

  • Anhui Provincal Cancer Hospital

    Hefei, Anhui, 230031

    Kaiyang Ding

    Recruiting

  • Qilu Hospital Of Shandong University

    Jinan, Shandong, 250000

    Ming Hou

    Recruiting

  • Provincial Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250021

    Xin Wang

    Recruiting

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu, 730050

    Jie Cui

    Recruiting

  • The First Affiliated Hospital of Henan University of science and Technology

    Luoyang, Henan, 450052

    Ling Qin

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330001

    Wuping Li

    Recruiting

  • The First Affiliated Hospital Of Nanchang University

    Nanchang, Jiangxi, 330006

    Fei Li

    Recruiting

  • The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

    Jingyan Xu

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266400

    Hongwei Xue

    Recruiting

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003

    Active, not recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Weili Zhao, zwl_trial@163.com

    Recruiting

  • Shanghai 6th People's Hospital

    Shanghai, Shanghai Municipality, 201306

    Active, not recruiting

  • Shaoxing People's Hospital

    Shaoxing, Zhejiang, 312000

    Jiaping Fu

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110002

    Xiaojing Yan

    Recruiting

  • PEKING University SHENZHEN Hospital

    Shenzhen, Guangdong, 518036

    Hongyu Zhang

    Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Jinhai Ren

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

    Zhengzi Qian

    Recruiting

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

    Shujuan Wen

    Recruiting

  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430023

    Liling Zhang

    Recruiting

  • Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

    Liang Huang

    Recruiting

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214043

    Xin Zhou

    Recruiting

  • The first Affiliated Hospital Of Xi'an Jiaotong University

    Xi’an, Shanxi, 710004

    Active, not recruiting

  • The Second Affiliated Hospital Of Xi'an Jiaotong University

    Xi’an, Shanxi, 710004

    Aili He

    Recruiting

  • The First Affiliated Hospital Of XIAMEN University

    Xiamen, Fujian, 361003

    Bing Xu

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

    Keshu Zhou

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Xinhua Wang

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Orelabrutinib + R-CHOP, Placebo + R-CHOP
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orelabrutinib + R-CHOPDrug

    Also called ICP-022+ R-CHOP

    The orelabrutinib is a white, round, uncoated tablet. The R-CHOP include rituximab, cyclophosphamide, doxorubicin, vincristine, and prednison.

  • Placebo + R-CHOPDrug

    The placebo is a white, round, uncoated tablet. The R-CHOP include rituximab, cyclophosphamide, doxorubicin, vincristine, and prednison.

Study groups in NCT05234684
Study groupRoleWhat they receive
Orelabrutinib+ R-CHOPExperimentalParticipants will receive 150 mg of oral orelabrutinib once daily with R-CHOP on day 1 of each cycle (21 days).
Receives: Drug: Orelabrutinib + R-CHOP
Placebo+ R-CHOPPlacebo comparatorParticipants will receive 150 mg placebo once daily with R-CHOP on day 1 of each cycle (21 days).
Receives: Drug: Placebo + R-CHOP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS)

    Progression free survival (PFS) accessed by independent review committee (IRC)

    Measured: Up to 3 years and 9 months

  2. Complete response rate (CRR) by independent review committee (IRC)

    Complete response rate (CRR) at the completion of combination therapy accessed by independent review committee (IRC)

    Measured: Up to 3 years and 9 months

Secondary outcomes (7)

  1. Complete response rate (CRR) by investigator

    Complete response rate (CRR) at the completion of combination therapy accessed by investigator

    Measured: Up to 3 years and 9 months

  2. Overall response rate (ORR) by independent review committee (IRC) and investigator

    Overall response rate (ORR) accessed by independent review committee (IRC) and investigator

    Measured: Up to 3 years and 9 months

  3. Overall response rate (ORR) at the completion of combination therapy by independent review committee (IRC) and investigator

    Overall response rate (ORR) at the completion of combination therapy accessed by independent review committee (IRC) and investigator

    Measured: Up to 3 years and 9 months

  4. Duration of Response (DOR)

    Duration of Response (DOR) accessed by independent review committee (IRC) and investigator

    Measured: Up to 3 years and 9 months

  5. Disease free survival (DFS) rate and event free survival (EFS) rate

    2-year disease free survival (DFS) rate and 2-year event free survival (EFS) rate

    Measured: Up to 2 years

  6. Overall survival (OS) rate

    2-year overall survival (OS) rate Accessed by independent review committee (IRC) and investigator

    Measured: Up to 2 years

  7. Occurrence of adverse events and serious adverse events according to CTCAE V5.0.

    The safety of Orelabrutinib measured by the occurrence of adverse events and serious adverse events according to CTCAE V5.0.

    Measured: Up to 3 years and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2022
  2. Study start2 Nov 2022
  3. Primary completion30 Jul 2024 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05234684
Sponsor's protocol ID
ICP-CL-00115
Acronym
BELIEVE-01
Status last verified
Feb 2024
First submitted
29 Jan 2022
Last updated
7 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Orelabrutinib + R-CHOP in people with Diffuse Large B Cell Lymphoma (DLBCL), run by Beijing InnoCare Pharma Tech Co., Ltd. at 44 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Weili Zhao (+86 021-64370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (time frame: Up to 3 years and 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05234684.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.

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