A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma
Who is this study for? Patients with treatment-na?ve mantle cell lymphoma
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
To evaluate the efficacy of orelabrutinib combined with R-CHOP vs. R-CHOP alone in the treatment of treatment-naїve mantle cell lymphoma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 80
Healthy Volunteers: f
View:
• 65 \< age \<80, or 60 ≤ age ≤65 and is ineligible for autologous stem cell transplantation as assessed by the investigator
• Histopathological confirmed MCL and either expression of cyclin D1 or t (11;14) chromosomal translocation (in association with CD20). The verification will be based on central review of the local pathology report.
• No previous systemic treatment for MCL.
• ECOG physical strength score is 0-2.
• Expected survival time \>6 months.
• Voluntary written informed consent prior to screening.
Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
West China Hospital,Sichuan University
NOT_YET_RECRUITING
Chengdu
The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITING
Guangxi
Guangzhou First People's Hospital
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
he First Affiliated Hospital of Zhengjiang University
NOT_YET_RECRUITING
Hangzhou
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Anhui Province Cancer Hospital
NOT_YET_RECRUITING
Hefei
Tumor in Hunan Province
NOT_YET_RECRUITING
Hunan
Shandong Provincial Hospital
NOT_YET_RECRUITING
Jinan
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Jiangsu Province Hospital
NOT_YET_RECRUITING
Nanjing
The First Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
The Fourth Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
The First Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
Hospital of Hematology, Chinese Academy of Medical Sciences
NOT_YET_RECRUITING
Tianjin
Tianjin Cancer Hospital
NOT_YET_RECRUITING
Tianjin
Wuhan Union Hospital
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
Henan Tumor Hospital
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
April Huang
April.huang@innocarepharma.com
010-66609723
Backup
Xinghua Zhao
Xinghua.zhao@innocarepharma.com
Time Frame
Start Date: 2021-12-22
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 356
Treatments
Experimental: the experimental group
Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
Experimental: The control group
R-CHOP
Related Therapeutic Areas
Sponsors
Leads: Beijing InnoCare Pharma Tech Co., Ltd.