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Spots Global Cancer Trial Database for A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL

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Trial Identification

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

Official Title: A Randomized, Open-Label, Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

Study ID: NCT04628494

Study Description

Brief Summary: 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

Detailed Description: The trial is an open label, multi-center, global phase 3 randomized trial of epcoritamab, GEN3013. The goal of this randomized trial is to evaluate the efficacy of epcoritamab (GEN3013, DuoBody®-CD3xCD20) compared to investigator's choice of chemotherapy, in patients with relapsed, refractory diffuse large B-Cell Lymphoma who have failed or are ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). No change in chemotherapy is permitted for participants during the treatment phase of the trial.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Indiana Blood and Marrow Transplantation, Indianapolis, Indiana, United States

Community Health Network Cancer Center North, Indianapolis, Indiana, United States

Henry Ford Health System, Jackson, Michigan, United States

Wake Forest Baptist Health, Winston-Salem, North Carolina, United States

TriHealth Cancer Institute- Good Samaritan Hospital, Cincinnati, Ohio, United States

LDS Hospital, Salt Lake City, Utah, United States

Flinders Medical Centre, Bedford Park, , Australia

Concord Repatriation General Hospital, Concord, , Australia

Peninsula Private Hospital Clinical Trials Unit, Frankston, , Australia

Icon Cancer Centre Corporate Office, South Brisbane, , Australia

Calvary Mater Newcastle, Waratah, , Australia

Westmead Hospital, Westmead, , Australia

Ordensklinikum Linz Barmherzige Schwestern, Linz, , Austria

Ordensklinikum Linz GmbH Elisabethinen, Linz, , Austria

Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III der PMU, Salzburg, , Austria

ZNA Middelheim, Antwerp, , Belgium

AZ Sint-Jan, Brugge, , Belgium

Institut Jules Bordet, Brussels, , Belgium

Universitair Ziekenhuis Gent, Gent, , Belgium

UZ Brussel, Jette, , Belgium

Hôpital de Jolimont, La Louvière, , Belgium

Universitair Ziekenhuis gasthuisberg Leuven, Leuven, , Belgium

AZ Nikolaas- Verenigde Ziekenhuizen van Waas en Durme, Sint-Niklaas, , Belgium

AZ Turnhout, Campus Sint-Elisabeth, Turnhout, , Belgium

CHU de Quebec-Universite Laval, Québec City, , Canada

Affiliated Hospital of Hebei University, Baoding, , China

Beijing Cancer Hospital, Beijing, , China

Beijing Tongren Hospital, Capital Medical University, Beijing, , China

The First Hospital of Jilin University, Changchun, , China

West China Hospital, Sichuan University, Chengdu, , China

The Second Hospital of Dalian Medical University, Dalian, , China

Guangdong Provincial Peoples Hospital, Guangdong, , China

Guangxi Medical University Affiliated Tumor Hospital, Guangxi, , China

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, , China

Hubei Cancer Hospital, Hubei, , China

Hunan Cancer Hospital, Hunan, , China

The First Affiliated Hospital of Nanchang University, Nanchang, , China

Qingdao Central Hospital, Qingdao, , China

Shanxi Provincial Cancer Hospital, Shanxi, , China

Shengjing Hospital of China Medical University, Shenyang, , China

Shenzhen Peoples Hospital, Shenzhen, , China

The First Affiliated Hospital of Soochow University, Suzhou, , China

Tianjin Medical University Cancer Institute and Hospital, Tianjin, , China

EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, , China

Yantai Yuhuangding Hospital, Yantai, , China

Henan Cancer Hospital, Zhengzhou, , China

The Second Affiliated Hospital Zhejiang University School of Medicine, Zhenjiang, , China

Aalborg Universitetshospital, Aalborg, , Denmark

Aarhus University Hospital, Department of Hematology, Clinical Research Unit C116, Aarhus, , Denmark

Clinical Research Unit, Roskilde Sygehus, Roskilde, , Denmark

Vejle Hospital, Vejle, , Denmark

HUS Cancer Center/ Clinical Trial Unit, Helsinki, , Finland

Oulu university hospital, Department of hematology, Oulu, , Finland

Audrey ALEME, Amiens, , France

Centre Hospitalier de la Côte Basque, Bayonne, , France

CHRU de Brest - Hospital Morvan, Brest, , France

CHU Caen - IHBN, Caen, , France

Groupe Hospitalier de La Rochelle, La Rochelle, , France

CHU de LIMOGES, Limoges, , France

Centre Léon Bérard, Lyon, , France

Hopital de la Conception APHM, Marseille, , France

CHU de Nantes - Hôtel Dieu, Nantes, , France

Centre Antoine Lacassagne, Nice, , France

Clinique Victor Hugo, Paris, , France

Hôpital Saint-Louis, Paris, , France

CHU de Bordeaux Hôpital Haut-Lévêque, Pessac, , France

Centre Hospitalier Lyon Sud, Pierre-Bénite, , France

CHU de Poitiers - Hôpital la Milétrie, Poitiers, , France

Centre Hospitalier Rene Dubos, Pontoise, , France

Ch Cornouaille, Quimper, , France

Centre Henri Becquerel, Rouen, , France

CHRU Tours Hôpital Bretonneau, Tours, , France

Uniklinik Köln, Klinik I für Innere Medizin, CIO Gebäude 70, 5.094, Cologne, , Germany

Universitaetsklinikum Essen, Essen, , Germany

Universitätsklinikum Schleswig-Holstein Medizinische Klinik II Hämatologie und Onkologie, Kiel, , Germany

Universitätsklinikum Würzburg, Würzburg, , Germany

National Institute of Oncology, Budapest, , Hungary

Semmelweis Egyetem Belgyógyászati és Onkológiai Klinika, Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia, Debrecen, , Hungary

Belgyógyászati osztály Markhot Ferenc Kórház, Eger, , Hungary

Petz Aladar Egyetemi Oktato Korhaz, Győr, , Hungary

Josa Andras Teaching Hospital, Hematology Dept, Nyiregyhaza, , Hungary

University of Pecs 1st. Internal medicine Clinic Dept. Hematology, Pécs, , Hungary

Szegedi Tudományegyetem II. sz. Belgyogyaszat, Hematologia, Szeged, , Hungary

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Szekesfehervar, , Hungary

Bnai Zion Medical Center, Haifa, , Israel

Rambam Health Care Center, Haifa, , Israel

Hadassah University Hospital, Jerusalem, , Israel

Shaare Zedek Medical Center, Jerusalem, , Israel

Sourasky Medical Center, Tel Aviv, , Israel

IRCCS Istituto Tumori Giovanni Paolo II Bari, Bari, , Italy

Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi), Bergamo, , Italy

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili), Brescia, , Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola, , Italy

Istituto Oncologico Europeo, Milan, , Italy

San Raffaele Hospital, Milan, , Italy

Azienda Ospedaliero - Universitaria Maggiore delle Carita SCDU Ematologia building C, Novara, , Italy

Ospedale Santa Maria delle Croci, Ravenna, , Italy

Azienda Ospedaliera Universitaria Policlinico Umberto I Università di Roma La Sapienza, Dip Med Tra, Rome, , Italy

IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy

Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) Ospedale Maggiore di Trieste, Trieste, , Italy

SC di Ematologia - AON SS Antonio e Biagio e Cesare Arrigo, Venezia, , Italy

Kyushu University Hospital, Fukuoka, , Japan

Fukushima Medical University Hospital, Fukushima, , Japan

Chugoku Central Hospital, Fukuyama, , Japan

Hokkaido University Hospital, Hokkaido, , Japan

National Cancer Center Hospital East, Kashiwa, , Japan

Kyoto University Medical Hospital, Kyoto, , Japan

Matsuyama Red Cross Hospital, Matsuyama, , Japan

Mie University Hospital, Mie, , Japan

Japanese Red Cross Nagoya Daini Hospital, Nagoya, , Japan

NHO Nagoya Medical Center, Nagoya, , Japan

Okayama University Hospital, Okayama, , Japan

Tohoku University Hospital, Sendai, , Japan

Keio University Hospital, Tokyo, , Japan

National Cancer Center Hospital, Tokyo, , Japan

Tokai University Hospital, Tokyo, , Japan

Fujita Health University Hospital, Toyoake, , Japan

Yamagata University Hospital, Yamagata, , Japan

Kindai University Hospital, Ōsaka-sayama, , Japan

Dong-A University Hospital, Busan, , Korea, Republic of

Pusan National University Hospital, Busan, , Korea, Republic of

Pusan National University Hosptial, Busan, , Korea, Republic of

Keimyung University Dongsan Hospital, Daegu, , Korea, Republic of

Chonbuk National University Hospital, Geumam, , Korea, Republic of

Asan Medical Center, Seoul, , Korea, Republic of

Samsung Medical Center, Seoul, , Korea, Republic of

Seoul National University Bundang Hospital, Seoul, , Korea, Republic of

Seoul National University Hospital, Seoul, , Korea, Republic of

Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of

Ulsan University Hospital, Ulsan, , Korea, Republic of

Rijnstate Arnhem, Arnhem, , Netherlands

Amphia Ziekenhuis, Interne Geneeskunde, Oncologie. Route 43, Breda, , Netherlands

Albert Schweitzer Ziekenhuis, Dordrecht, , Netherlands

Admiraal de Ruyter Ziekenhuis, Goes, , Netherlands

Bravis Ziekenhuis, Roosendaal, , Netherlands

Erasmus MC, Rotterdam, , Netherlands

Franciscus Gasthuis And Vlietland, Rotterdam, , Netherlands

Oslo University Hospital location Radium hospital, Oslo, , Norway

St. Olavs Hospital HF, Trondheim, , Norway

Pratia Onkologia Katowice, Katowice, , Poland

Pratia MCM Kraków, Kraków, , Poland

Centrum Medyczne Pratia Poznan, Skorzewo, , Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Wrocław, , Poland

Instytut Centrum Zdrowia Matki Polki, Łódź, , Poland

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii, Łódź, , Poland

State Autonomous Institution of Healthcare Republican Clinical Oncological Dispensary of the Ministr, Kazan, , Russian Federation

State Budgetary Institution of Healthcare Leningrad Regional Clinical Hospital, Leningrad, , Russian Federation

Federal State Budgetary Institution of Science, Moscow, , Russian Federation

Federal State Budgetary Institution, Moscow, , Russian Federation

State Budgetary Institution of Healthcare of Nizhniy Novgorod region, 1st inpatient facility, 5th fl, Nizhny Novgorod, , Russian Federation

Federal State Budgetary Institution V.A. Almazov National Medical Research Center of the Ministry of, Saint Petersburg, , Russian Federation

National University Hospital, Kent Ridge, , Singapore

Clinical Trials and Research Centre, Singapore, , Singapore

National Cancer Centre Singapore, Singapore, , Singapore

ICO Badalona - Hospital Universitari Germans Trias i Pujol, Badalona, , Spain

ICO l'Hospitalet - Hospital Duran i Reynals, Barcelona, , Spain

Hospita Universitario Puerta Del Mar, Cadiz, , Spain

Hospital San Pedro de Alcántara, Cáceres,, , Spain

Hospital San Pedro de Alcántara, Cáceres, , Spain

Hospital Universitario Reina Sofía, Córdoba, , Spain

Hospital Arnau de Vilanova, Lleida, , Spain

Hospital Universitario 12 de Octubre, Madrid, , Spain

Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain

Hospital Universitario Ramon y Cajal, Madrid, , Spain

Md Anderson Cancer Center, Madrid, , Spain

Hospital Universitario de Salamanca, Salamanca, , Spain

Hospital Universitario Marqués de Valdecilla, Santander, , Spain

Hospital Universitario Virgen De Valme, Sevilla, , Spain

Hospital Universitario Virgen del Rocío, Sevilla, , Spain

Hospital Universitario Virgen Macarena, Sevilla, , Spain

Karolinska university Hospital, Stockholm, , Sweden

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan

National Cheng Kung University Hospital, Tainan, , Taiwan

National Taiwan University Hospital, Taipei, , Taiwan

Taipei Veterans General Hospital, Taipei, , Taiwan

Tri-Service General Hospital, Taipei, , Taiwan

Ankara University Medical Faculty, Ankara, , Turkey

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi, Ankara, , Turkey

Gazi University Medical Faculty, Ankara, , Turkey

Amerikan Hospital, Istanbul, , Turkey

Iqvia Tibbi Istatistik, Istanbul, , Turkey

Istanbul University Cerrahpasa - Cerrahpasa Tip Fakultesi, Istanbul, , Turkey

Istanbul University Medical Faculty, Istanbul, , Turkey

Dokuz Eylul University Medical Faculty, İzmir, , Turkey

Ege University Medical Faculty, İzmir, , Turkey

Tekirdag Namik Kemal University, Tekirdağ, , Turkey

Karadeniz Technical University, Trabzon, , Turkey

Haematology - University Hospitals Birmingham NHS Foundation Trust, Birmingham, , United Kingdom

Guys and St Thomas NHS Foundation Trust, London, , United Kingdom

Hammersmith Hospital, London, , United Kingdom

Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, , United Kingdom

Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom

Derriford Hospital, Plymouth, , United Kingdom

University Hospital Southampton, Southampton, , United Kingdom

Royal Marsden NHS Foundation Trust (Sutton), Sutton, , United Kingdom

Royal Cornwall Hospital, Truro, , United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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