A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP-X) versus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with diffuse large B-cell lymphoma
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Histologically-confirmed diffuse large B-cell lymphoma (without central nervous system involvement)
• Availability of archival or freshly collected tumor tissue before study enrolment
• International Prognostic Index (IPI) score of 2-5 or 1 with bulky disease
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
• Life expectancy greater than or equal to (\>/=) 6 months
• The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research
Locations
Other Locations
China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Weili Zhao
zwl_trial@163.com
+862164370045
Backup
Pengpeng Xu
pengpeng_xu@126.com
+862164370045
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 1100
Treatments
Experimental: R-CHOP-X
Patients in R-CHOP-X group will receive rituximab 375 mg/m² IV on day 1, cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 2, and prednisone 100 mg/day PO on days 2-6 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive orelabrutinib 150 mg/day PO on days 1-21, or lenalidomide 25 mg/day PO on days 2-11, or decitabine 10 mg/m² IV on days -5 to -1 followed by standard R-CHOP of every 21-day cycle.
Active_comparator: R-CHOP
Patients in R-CHOP group will receive rituximab 375 mg/m² IV on day 1, cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² iv, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 2, and prednisone 100 mg/day PO on days 2-6 of every 21-day cycle for 6 cycles.
Related Therapeutic Areas
Sponsors
Collaborators: Liaoning Cancer Hospital & Institute, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Pekcing Union Medical College, RenJi Hospital, Shandong Cancer Hospital and Institute, The First Affiliated Hospital of Anhui Medical University North District, Fudan University, Fifth Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, Henan Cancer Hospital, Air Force Military Medical University, China, The Second Affiliated Hospital of Dalian Medical University, Beijing Hospital, Harbin Institute of Hematology, Yunnan First People's Hospital, China-Japan Friendship Hospital, Qilu Hospital of Shandong University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Affiliated Cancer Hospital of Harbin Medical University, Peking University Third Hospital, Tongji Hospital, Beijing Tongren Hospital, First Affiliated Hospital of Harbin Medical University, The First Hospital of Jilin University, Hunan Cancer Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Cancer Hospital Affiliated to Xinjiang Medical University, Affiliated Hospital of Nantong University, Central South University, The Affiliated Hospital of Xuzhou Medical University, Affiliated Zhongshan Hospital of Dalian University, The First Affiliated Hospital of University of Science and Technology of China, The Second Hospital of Anhui Medical University, The First Affiliated Hospital of Nanchang University, First Affiliated Hospital Xi'an Jiaotong University, The First Affiliated Hospital of Xiamen University, West China Hospital, Sichuan, Yunnan Cancer Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Affiliated Hospital of Guilin Medical College, Zhujiang Hospital, Gansu Cancer Hospital, The Third Affiliated Hospital of Wenzhou Medical University, Shanxi Province Cancer Hospital, Zhongda Hospital, First Affiliated Hospital of Chongqing Medical University, The First Affiliated Hospital of Zhengzhou University, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, LanZhou University, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital of Anhui Medical University, Fujian Medical University Union Hospital, Yantai Yuhuangding Hospital
Leads: Ruijin Hospital