A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With MCD Subtype Diffuse Large B-cell Lymphoma
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Interventions
- Drug: Placebo + R-CHOP
- Registration Number
- NCT05234684
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- 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.
- 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.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo+ R-CHOP Placebo + R-CHOP Participants will receive 150 mg placebo once daily with R-CHOP on day 1 of each cycle (21 days). Orelabrutinib+ R-CHOP Orelabrutinib + R-CHOP Participants will receive 150 mg of oral orelabrutinib once daily with R-CHOP on day 1 of each cycle (21 days).
- Primary Outcome Measures
Name Time Method Complete response rate (CRR) by independent review committee (IRC) Up to 3 years and 9 months Complete response rate (CRR) at the completion of combination therapy accessed by independent review committee (IRC)
Progression free survival (PFS) Up to 3 years and 9 months Progression free survival (PFS) accessed by independent review committee (IRC)
- Secondary Outcome Measures
Name Time Method Complete response rate (CRR) by investigator Up to 3 years and 9 months Complete response rate (CRR) at the completion of combination therapy accessed by investigator
Overall response rate (ORR) by independent review committee (IRC) and investigator Up to 3 years and 9 months Overall response rate (ORR) accessed by independent review committee (IRC) and investigator
Overall response rate (ORR) at the completion of combination therapy by independent review committee (IRC) and investigator 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
Duration of Response (DOR) Up to 3 years and 9 months Duration of Response (DOR) accessed by independent review committee (IRC) and investigator
Disease free survival (DFS) rate and event free survival (EFS) rate Up to 2 years 2-year disease free survival (DFS) rate and 2-year event free survival (EFS) rate
Overall survival (OS) rate Up to 2 years 2-year overall survival (OS) rate Accessed by independent review committee (IRC) and investigator
Occurrence of adverse events and serious adverse events according to CTCAE V5.0. 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.
Trial Locations
- Locations (44)
PEKING University SHENZHEN Hospital
🇨🇳Shenzhen, Guangdong, China
Sun Yat-sen University Cancer Center Internal medicine department
🇨🇳Guandong, Guangzhou, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
The first affiliated hospital of bengbu medical college
🇨🇳Bengbu, Anhui, China
Anhui Provincal Cancer Hospital
🇨🇳Hefei, Anhui, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Chongqing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
The Southwest Hospital of AMU
🇨🇳Chongqing, Chongqing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital Of XIAMEN University
🇨🇳Xiamen, Fujian, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Gansu Provincial Cancer Hospital
🇨🇳Lanzhou, Gansu, China
The First People's Hospital of Foshan
🇨🇳Foshan, Guangdong, China
ZhuJiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
Chenzhou first people's Hospital
🇨🇳Chenzhou, Hunan, China
The Second Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
Provincial Hospital Affiliated to Shandong First Medical University
🇨🇳Jinan, Shandong, China
West China Hospital Sichuan University
🇨🇳Chengdu, Sichuan, 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
Tianjin Cancer Hospital
🇨🇳Tianjin, Tianjin, China
Affiliated Cancer Hospital of Xinjiang Medical University
🇨🇳Ürümqi, Xinjiang, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, Hebei, China
The First Affiliated Hospital of Henan University of science and Technology
🇨🇳Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The Second Hospital of Hebei Medical University
🇨🇳Shijia Zhuang, Hebei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Union 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
Jiangxi Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
The Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China
Qilu Hospital Of Shandong University
🇨🇳Jinan, Shandong, China
The First Affiliated Hospital Of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Shanghai Changzheng Hospital
🇨🇳Shanghai, Shanghai, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
The first Affiliated Hospital Of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Shanghai 6th People's Hospital
🇨🇳Shanghai, Shanghai, China
The Second Affiliated Hospital Of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China