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A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
Sponsor: InnoCare Pharma Inc.
Summary
Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)
Official title: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) Vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
476
Start Date
2024-05-29
Completion Date
2032-06-25
Last Updated
2024-12-27
Healthy Volunteers
No
Conditions
Interventions
Orelabrutinib
Eligible patients will receive Orelabrutinib orally as per the protocol，until disease progression or other reasons for treatment discontinuation，whichever comes first.
Bendamustine Injection
Eligible patients will receive Bendamustine by injection as per the protocol
Rituximab
Eligible patients will receive Rituximab by injection as per the protocol
Orelabrutinib Placebo
Eligible patients will receive Orelabrutinib Placebo orally as per the protocol
Locations (39)
Beijing Cancer Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
The First Affiliated Hospital of Bengbu Medical University
Bengbu, China
First Hospital of Jilin University
Changchun, China
Hunan Cancer Hospital
Changsha, China
The First People's Hospital of Changzhou
Changzhou, China
Sichuan Provincial People's Hospital
Chengdu, China
West China Hospital of Sichuan University
Chengdu, China
Chongqinq Cancer Hospital
Chongqing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
The second Hospital of Dalian Medical University
Dalian, China
Fujing Cancer Hospital
Fuzhou, China
Union Hospital Affiliated to Fujian Medical University
Fuzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Zhejiang University Medical School affiliated to the first Hospital
Hangzhou, China
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Cancer Hospital of Shandong First Medical University
Jinan, China
Shandong Provincial Hospital
Jinan, China
The First Affiliated Hospital of Ningbo University
Jinan, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
Nanjing, China
Cancer Hospital Affiliated to Fudan University
Shanghai, China
Huashan Hospital of Fudan University
Shanghai, China
Shengjing Hospital of China Medical University
Shenyang, China
The First Affiliated Hospital of China Medical University
Shenyang, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Shanxi Cancer Hospital
Taiyuan, China
Tianjin Cancer Hospital
Tianjin, China
The Tumor Hospital Affiliated to Xinjiang Medical University
Ürümqi, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and
Wuhan, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and
Wuhan, China
The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital)
Xi'an, China
The Second Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, China
Yibin Second People's Hospital
Yibin, China
Henan Cancer Hospital
Zhengzhou, China
Henan Provincial People's Hospital
Zhengzhou, China