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
Who is this study for? Patients with Diffuse Large B Cell Lymphoma (DLBCL)
What treatments are being studied? R-CHOP
Status: Recruiting
Location: See all (44) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Affiliated Hospital of Hebei University
RECRUITING
Baoding
Beijing Hospital
RECRUITING
Beijing
The first affiliated hospital of bengbu medical college
RECRUITING
Bengbu
Hunan Cancer Hospital
RECRUITING
Changsha
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
West China Hospital Sichuan University
ACTIVE_NOT_RECRUITING
Chengdu
Chenzhou first people's Hospital
RECRUITING
Chenzhou
Chongqing University Cancer Hospital
RECRUITING
Chongqing
The Southwest Hospital of AMU
RECRUITING
Chongqing
The Second Hospital of Dalian Medical University
RECRUITING
Dalian
The First People's Hospital of Foshan
RECRUITING
Foshan
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center Internal medicine department
RECRUITING
Guandong
Guangdong General Hospital
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
ZhuJiang Hospital of Southern Medical University
RECRUITING
Guangzhou
Sir Run Run Shaw Hospital Zhejiang University School Of Medicine
RECRUITING
Hangzhou
The first affiliated Hospital Zhejiang University School Of Medicine
RECRUITING
Hangzhou
Anhui Provincal Cancer Hospital
RECRUITING
Hefei
Provincial Hospital Affiliated to Shandong First Medical University
RECRUITING
Jinan
Qilu Hospital Of Shandong University
RECRUITING
Jinan
Gansu Provincial Cancer Hospital
RECRUITING
Lanzhou
The First Affiliated Hospital of Henan University of science and Technology
RECRUITING
Luoyang
Jiangxi Cancer Hospital
RECRUITING
Nanchang
The First Affiliated Hospital Of Nanchang University
RECRUITING
Nanchang
The Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
The Affiliated Hospital of Qingdao University
RECRUITING
Qingdao
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Shanghai 6th People's Hospital
ACTIVE_NOT_RECRUITING
Shanghai
Shanghai Changzheng Hospital
ACTIVE_NOT_RECRUITING
Shanghai
Shaoxing People's Hospital
RECRUITING
Shaoxing
The First Hospital of China Medical University
RECRUITING
Shenyang
PEKING University SHENZHEN Hospital
RECRUITING
Shenzhen
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Tianjin Cancer Hospital
RECRUITING
Tianjin
Affiliated Cancer Hospital of Xinjiang Medical University
RECRUITING
Ürümqi
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Wuxi People's Hospital
RECRUITING
Wuxi
The first Affiliated Hospital Of Xi'an Jiaotong University
ACTIVE_NOT_RECRUITING
Xi’an
The Second Affiliated Hospital Of Xi'an Jiaotong University
RECRUITING
Xi’an
The First Affiliated Hospital Of XIAMEN University
RECRUITING
Xiamen
Henan Cancer Hospital
RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Weili Zhao
zwl_trial@163.com
+86 021-64370045
Time Frame
Start Date: 2022-11-02
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 150
Treatments
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).
Placebo_comparator: Placebo+ R-CHOP
Participants will receive 150 mg placebo once daily with R-CHOP on day 1 of each cycle (21 days).
Related Therapeutic Areas
Sponsors
Leads: Beijing InnoCare Pharma Tech Co., Ltd.