研究单位：[1]Regeneron Pharmaceuticals[2]Rush University Medical Center,Chicago,Illinois,United States,60612[3]University of Iowa Hospital and Clinics,Iowa City,Iowa,United States,52242[4]Norton Cancer Institute,Louisville,Kentucky,United States,40207[5]Beth Israel Deaconess Medical Center,Boston,Massachusetts,United States,02215[6]Tufts Cancer Center,Boston,Massachusetts,United States,02332[7]University of Michigan,Ann Arbor,Michigan,United States,48109[8]University/Academic Hospital Mayo Clinic,Rochester,Minnesota,United States,55905[9]SSM Saint Louis University Hospital,Saint Louis,Missouri,United States,63110[10]John Theurer Cancer Center Hackensack University Medical Center,Hackensack,New Jersey,United States,07601[11]Morristown Medical Center,Morristown,New Jersey,United States,07960[12]Weill Cornell Medical College,New York,New York,United States,10021[13]Stony Brook Hospital,Stony Brook,New York,United States,11794[14]Wake Forest Baptist Medical Center,Winston-Salem,North Carolina,United States,27157[15]Cleveland Clinic,Cleveland,Ohio,United States,44195[16]Stephenson Cancer Center,Oklahoma City,Oklahoma,United States,73104[17]Simmons Comprehensive Cancer Center,Dallas,Texas,United States,75390[18]Brook Army Medical Center,Fort Sam Houston,Texas,United States,78234[19]Border Medical Oncology, Albury Wodonga Regional Cancer Centre,East Albury,Australia,NSW 2640[20]Epworth Hospital,East Melbourne,Australia,VIC 3002[21]Penninsula & South Eastern Haemotology and Oncology Group,Frankston,Australia,VIC 3199[22]Andrew Love Cancer Center,Geelong,Australia,VIC 3220[23]Olivia Newton John Cancer Centre,Heidelberg,Australia,VIC 3084[24]The Tweed Hospital,Murdoch,Australia,NSW 2485[25]Royal Perth Hospital,Perth,Australia,6000[26]Andrew Love Cancer Center,Tweed Heads,Australia,VIC3220[27]Cross Cancer Center,Edmonton,Alberta,Canada,T6G172[28]QEII Health Science Center,Halifax,Nova Scotia,Canada,B3H 2Y9[29]Peking University Cancer Hospital (Beijing Cancer Hospital) (Beijing Institute for Cancer Research),Beijing,Beijing,China,100142[30]Sun Yat-Sen University Cancer Center (Cancer Prevention and Treatment Center, Sun Yat-sen University),Guanngzhou City,Guangdong,China,150060[31]The First Affiliated Hospital of Zhengzhou University,Zhengzhou City,Henan,China,450052[32]West China Hospital of Sichuan University,Chengdu,Sichuan,China,610041[33]Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology,Qiaokou District,Wuhan Hubei Province,China,430030[34]The Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou,Zhejiang,China,310052[35]The First Affiliated Hospital, Zhejiang University School of Medicine,Shangcheng District Hangzhou,Zhejiang,China,310003[36]Peking University Third Hospital,Beijing City Beijing,China,100191[37]Peking Union Medical College Hospital,Beijing City, Beijing,China,100730[38]The First Bethune Hospital Of Jilin University,Chaoyang District Changchun,China,130021[39]The First Affiliated Hospital of Soochow University,Gusu District Suzhou,China,215031[40]Tianjin Medical University Cancer Institute & Hospital,HeXi District Tianjin City,China,300060[41]Harbin Medical University Cancer Hospital,Nangang District Harbin Heilongjiang,China,150000[42]Second Affiliated Hospital of Army Medical University, PLA,Shapingba District Chongqing,China,400000[43]Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences,Tianjin City Tianjin,China,300020[44]Renmin Hospital of Wuhan University,Wuhan Hubei Province,China,430060[45]Fudan University Cancer Hospital,Xuhui District Shanghai,China,200032[46]The First Affiliated Hospital of Xi 'an Jiaotong University,Yanta District Xi'an Shanxi,China,710000[47]CHU de Caen,Caen,France,14 000[48]Hospital Henri Mondor,Créteil,France,94010[49]Hopital Huriez-CHRU Lille,Lille,France,59037[50]CHU de Nantes,Nantes,F
Primary objective is to assess the anti-tumor activity of single agent odronextamab as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review in each of the following B-cell non-Hodgkin lymphoma (B-NHL) subgroups: - In patients with follicular lymphoma (FL) grade 1-3a *1,2 - In patients with diffuse large B-cell lymphoma (DLBCL) *1,2 - In patients with mantle cell lymphoma (MCL) that has relapsed after or is refractory to a BTK inhibitor. This cohort will also include patients who have relapsed or have disease refractory to prior systemic therapy, or patients who have demonstrated intolerance to BTK inhibitor therapy, and who have progressed after other systemic therapy. - In patients with marginal zone lymphoma (MZL) *1 - In patients with other B-NHL subtypes *1 Secondary objectives are: - To assess the anti-tumor activity of single agent odronextamab in each of 5 disease-specific cohorts, as measured by: - ORR according to the Lugano Classification and as assessed by local investigator evaluation - Complete response (CR) rate according to the Lugano Classification and as assessed local by local investigator evaluation and independent central review - Progression-free survival (PFS)*3 - Overall survival (OS) - Duration of response (DOR)*3 - Disease control rate (DCR)*3 - To evaluate the safety and tolerability of odronextamab - To assess the pharmacokinetics (PK) of odronextamab - To assess the immunogenicity of odronextamab - To assess the effect of odronextamab on patient reported outcomes, including health-related quality of life (HRQL), as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym), and EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L) - 1 that has relapsed after or is refractory to at least 2 prior lines of systemic therapy - 2 including an anti-CD20 antibody and an alkylating agent - 3 according to Lugano Classification and as assessed by independent central review and local investigator evaluation
