A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With MCD Subtype Diffuse Large B-cell Lymphoma
NCT ID: NCT05234684
Last Updated: 2024-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2022-11-02
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Orelabrutinib+ R-CHOP
Participants will receive 150 mg of oral orelabrutinib once daily with R-CHOP on day 1 of each cycle (21 days).
Orelabrutinib + R-CHOP
The orelabrutinib is a white, round, uncoated tablet. The R-CHOP include rituximab, cyclophosphamide, doxorubicin, vincristine, and prednison.
Placebo+ R-CHOP
Participants will receive 150 mg placebo once daily with R-CHOP on day 1 of each cycle (21 days).
Placebo + R-CHOP
The placebo is a white, round, uncoated tablet. The R-CHOP include rituximab, cyclophosphamide, doxorubicin, vincristine, and prednison.
Interventions
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Orelabrutinib + R-CHOP
The orelabrutinib is a white, round, uncoated tablet. The R-CHOP include rituximab, cyclophosphamide, doxorubicin, vincristine, and prednison.
Placebo + R-CHOP
The placebo is a white, round, uncoated tablet. The R-CHOP include rituximab, cyclophosphamide, doxorubicin, vincristine, and prednison.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Weili Zhao
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
Anhui Provincal Cancer Hospital
Hefei, Anhui, China
Beijing Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
The Southwest Hospital of AMU
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital Of XIAMEN University
Xiamen, Fujian, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
Guangdong General Hospital
Guangzhou, Guangdong, China
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
PEKING University SHENZHEN Hospital
Shenzhen, Guangdong, China
Sun Yat-sen University Cancer Center Internal medicine department
Guandong, Guangzhou, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan University of science and Technology
Luoyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Chenzhou first people's Hospital
Chenzhou, Hunan, China
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Qilu Hospital Of Shandong University
Jinan, Shandong, China
Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, China
The first Affiliated Hospital Of Xi'an Jiaotong University
Xi’an, Shanxi, China
The Second Affiliated Hospital Of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The first affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
Shaoxing People's Hospital
Shaoxing, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Yanli Yang
Role: primary
Kaiyang Ding
Role: primary
Hui Liu
Role: primary
Yingyu Nan
Role: primary
Shuangnian Xu
Role: primary
Jianzhen Shen
Role: primary
Bing Xu
Role: primary
Jie Cui
Role: primary
Ying Zhao
Role: primary
Wenyu Li
Role: primary
Shaojie Wu
Role: primary
Chunkang Chang
Role: primary
Hongyu Zhang
Role: primary
Qingqing Cai
Role: primary
Hua Xue
Role: primary
Jinhai Ren
Role: primary
Ling Qin
Role: primary
Keshu Zhou
Role: primary
Xinhua Wang
Role: primary
Liling Zhang
Role: primary
Liang Huang
Role: primary
Hongling Peng
Role: primary
Hui Zhou
Role: primary
Xinquan Liang
Role: primary
Jingyan Xu
Role: primary
Xin Zhou
Role: primary
Wuping Li
Role: primary
Fei Li
Role: primary
Xiuhua Sun
Role: primary
Xiaojing Yan
Role: primary
Ming Hou
Role: primary
Xin Wang
Role: primary
Hongwei Xue
Role: primary
Aili He
Role: primary
Zhengzi Qian
Role: primary
Shujuan Wen
Role: primary
Jie Jin
Role: primary
Jin Zhang
Role: primary
Jiaping Fu
Role: primary
Other Identifiers
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ICP-CL-00115
Identifier Type: -
Identifier Source: org_study_id
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