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A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL

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研究单位: [1]Genmab [2]AbbVie [3]Indiana Blood and Marrow Transplantation,Indianapolis,Indiana,United States,46237 [4]Community Health Network Cancer Center North,Indianapolis,Indiana,United States,46250 [5]Henry Ford Health System,Jackson,Michigan,United States,49201 [6]Wake Forest Baptist Health,Winston-Salem,North Carolina,United States,27157 [7]TriHealth Cancer Institute- Good Samaritan Hospital,Cincinnati,Ohio,United States,45247 [8]LDS Hospital,Salt Lake City,Utah,United States,84143 [9]Flinders Medical Centre,Bedford Park,Australia [10]Concord Repatriation General Hospital,Concord,Australia [11]Peninsula Private Hospital Clinical Trials Unit,Frankston,Australia [12]Icon Cancer Centre Corporate Office,South Brisbane,Australia [13]Calvary Mater Newcastle,Waratah,Australia [14]Westmead Hospital,Westmead,Australia [15]Ordensklinikum Linz Barmherzige Schwestern,Linz,Austria [16]Ordensklinikum Linz GmbH Elisabethinen,Linz,Austria [17]Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III der PMU,Salzburg,Austria [18]ZNA Middelheim,Antwerp,Belgium [19]AZ Sint-Jan,Brugge,Belgium [20]Institut Jules Bordet,Brussels,Belgium [21]Universitair Ziekenhuis Gent,Gent,Belgium [22]UZ Brussel,Jette,Belgium [23]Hôpital de Jolimont,La Louvière,Belgium [24]Universitair Ziekenhuis gasthuisberg Leuven,Leuven,Belgium [25]AZ Nikolaas- Verenigde Ziekenhuizen van Waas en Durme,Sint-Niklaas,Belgium [26]AZ Turnhout, Campus Sint-Elisabeth,Turnhout,Belgium [27]CHU de Quebec-Universite Laval,Québec City,Canada [28]Affiliated Hospital of Hebei University,Baoding,China [29]Beijing Cancer Hospital,Beijing,China [30]Beijing Tongren Hospital, Capital Medical University,Beijing,China [31]The First Hospital of Jilin University,Changchun,China [32]West China Hospital, Sichuan University,Chengdu,China [33]The Second Hospital of Dalian Medical University,Dalian,China [34]Guangdong Provincial Peoples Hospital,Guangdong,China [35]Guangxi Medical University Affiliated Tumor Hospital,Guangxi,China [36]The First Affiliated Hospital, Zhejiang University School of Medicine,Hangzhou,China [37]Hubei Cancer Hospital,Hubei,China [38]Hunan Cancer Hospital,Hunan,China [39]The First Affiliated Hospital of Nanchang University,Nanchang,China [40]Qingdao Central Hospital,Qingdao,China [41]Shanxi Provincial Cancer Hospital,Shanxi,China [42]Shengjing Hospital of China Medical University,Shenyang,China [43]Shenzhen Peoples Hospital,Shenzhen,China [44]The First Affiliated Hospital of Soochow University,Suzhou,China [45]Tianjin Medical University Cancer Institute and Hospital,Tianjin,China [46]EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology,Wuhan,China [47]Yantai Yuhuangding Hospital,Yantai,China [48]Henan Cancer Hospital,Zhengzhou,China [49]The Second Affiliated Hospital Zhejiang University School of Medicine,Zhenjiang,China [50]Aalborg Universitetshospital,Aalborg,Denmark [51]Aarhus University Hospital, Department of Hematology, Clinical Research Unit C116,Aarhus,Denmark [52]Clinical Research Unit, Roskilde Sygehus,Roskilde,Denmark [53]Vejle Hospital,Vejle,Denmark [54]HUS Cancer Center/ Clinical Trial Unit,Helsinki,Finland [55]Oulu university hospital, Department of hematology,Oulu,Finland [56]Audrey ALEME,Amiens,France [57]Centre Hospitalier de la Côte Basque,Bayonne,France [58]CHRU de Brest - Hospital Morvan,Brest,France [59]CHU Caen - IHBN,Caen,France [60]Groupe Hospitalier de La Rochelle,La Rochelle,France [61]CHU de LIMOGES,Limoges,France [62]Centre Léon Bérard,Lyon,France [63]Hopital de la Conception APHM,Marseille,France [64]CHU de Nantes - Hôtel Dieu,Nantes,France [65]Centre Antoine Lacassagne,Nice,France [66]Clinique Victor Hugo,Paris,France [67]Hôpital Saint-Louis,Paris,France [68]CHU de Bordeaux Hôpital Haut-Lévêque,Pessac,France [69]Centre Hospitalier Lyon Sud,Pierre-Bénite,France [70]CHU de Poitiers - Hôpital la Milétrie,Poitiers,France [71]Centre Hospitalier Rene Dubos,Pontoise,France [72]Ch Cornouaille,Quimper,France [73]Centre Henri Bec

关键词: double-hit DLBCL triple-hit DLBCL follicular grade 3B transformed DLBCL T-cell histiocytes-rich large B cell lymphoma

研究目的:
The drug that will be investigated in the study is an antibody, epcoritamab, also known as EPKINLY™ and GEN3013. Since the safety and tolerability of epcoritamab has already been studied in previous studies in humans, the main purpose of this study is to evaluate efficacy. To evaluate this, half of the participants who are eligible will receive epcoritamab and the other half will receive a pre-specified investigator's choice of chemotherapy. Epcoritamab will be studied in R/R DLBCL participants who did not respond to a previous autologous stem cell transplant (ASCT) or do not meet the criteria for ASCT

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