En undersøgelse for at sammenligne hvor godt Odronextamab kombineret med kemoterapi virker, og hvor sikkert det er mod rituximab kombineret med kemoterapi, hos patienter med tidligere ubehandlet diffust stort B-cellet lymfom (OLYMPIA-3)
3. november 2026 opdateret af: Regeneron Pharmaceuticals
Et fase 3, åbent, randomiseret studie, der sammenligner effektiviteten og sikkerheden af Odronextamab (REGN1979), et anti-CD20 × anti-CD3 bispecifikt antistof, i kombination med CHOP (O-CHOP) versus Rituximab i kombination med CHOP (R-CHOP) ) hos tidligere ubehandlede deltagere med diffust stort B-cellet lymfom (DLBCL) (OLYMPIA-3)
This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called "previously untreated"). Patients with DLBCL that have come back after treatment (called "relapsed"), or have not responded to treatment (called "refractory"), can also participate in this study.
This study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study.
The aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. Standard of care means the usual medication expected and used when receiving treatment for a condition.
The study is looking at several other research questions, including:
- What side effects may happen from taking the study drug when combined with chemotherapy
- How much study drug is in the blood at different times
- Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
- The impact from the study drug on quality of life and ability to complete routine daily activities
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
904
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Clinical Trials Administrator
- Telefonnummer: 844-734-6643
- E-mail: clinicaltrials@regeneron.com
Studiesteder
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New South Wales
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Liverpool, New South Wales, Australien, 2170
- Rekruttering
- Liverpool Hospital
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Waratah, New South Wales, Australien, 2298
- Rekruttering
- Calvary Mater Newcastle
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Queensland
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Auchenflower, Queensland, Australien, 4066
- Rekruttering
- Icon Cancer Centre - Wesley
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Benowa, Queensland, Australien, 4217
- Rekruttering
- Pindara Private Hospital
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Victoria
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East Melbourne, Victoria, Australien, 3121
- Rekruttering
- Epworth Freemasons
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Brussels, Belgien, 1000
- Rekruttering
- Institut Jules Bordet
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Antwerp
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Herentals, Antwerp, Belgien, 2200
- Rekruttering
- AZ St.-Elisabeth Herentals vzw
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Liege
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Verviers, Liege, Belgien, 4800
- Rekruttering
- Centre Hospitalier Regional de Verviers
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgien, 9000
- Rekruttering
- Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
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West-Vlaanderen
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Roeselare, West-Vlaanderen, Belgien, 8800
- Rekruttering
- Algemeen Ziekenhuis AZ Delta
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Rio de Janeiro, Brasilien, 22793-334
- Rekruttering
- Instituto Americas
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Rio de Janeiro, Brasilien, 20231050
- Rekruttering
- Instituto Nacional de Cancer Jose Alencar Gomes da Silva
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São Paulo, Brasilien, 01509-010
- Rekruttering
- AC Camargo Cancer Center
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São Paulo, Brasilien, 01323-903
- Rekruttering
- Hospital Alemao Oswaldo Cruz
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São Paulo, Brasilien, 05403-000
- Rekruttering
- Clinical Hospital of Medicine School at Sao Paulo University
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São Paulo, Brasilien, 08270-070
- Rekruttering
- Casa de Saude Santa Marcelina
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São Paulo, Brasilien, 05403-010
- Rekruttering
- Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
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Estado de Bahia
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Salvador, Estado de Bahia, Brasilien, 41950-640
- Rekruttering
- Ensino e Terapia de Inovacao Clinica Amo (Etica)
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Federal District
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Brasília, Federal District, Brasilien, 70200-730
- Rekruttering
- Hospital Sirio Libanes Brasilia
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasilien, 30380-472
- Rekruttering
- Instituto Mario Penna de Ensino Pesquisa e Inovacao
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Paraná
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Cascavel, Paraná, Brasilien, 85806-300
- Rekruttering
- Uopeccan Hospital do Cancer de Cascavel
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Curitiba, Paraná, Brasilien, 81520-060
- Rekruttering
- Hospital Erasto Gaertner
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brasilien, 59062-000
- Rekruttering
- Liga Norte Riograndense Contra o Cancer
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Rio Grande do Sul
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Bento Gonçalves, Rio Grande do Sul, Brasilien, 95700-084
- Rekruttering
- Instituto Tacchini de Pesquisa em Saude
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Porto Alegre, Rio Grande do Sul, Brasilien, 90035-903
- Rekruttering
- Hospital de Clinicas de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brasilien, 90110-270
- Rekruttering
- Centro Gaucho Integrado
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Santa Catarina
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Joinville, Santa Catarina, Brasilien, 89201-260
- Rekruttering
- Centro de Hematologia e Oncologia
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Lages, Santa Catarina, Brasilien, 88501-001
- Rekruttering
- Animi Unidade de Tratamento Oncologico Ltda
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São Paulo
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Barretos, São Paulo, Brasilien, 14784-400
- Rekruttering
- Fundacao Pio XII - Hospital de Amor
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Jaú, São Paulo, Brasilien, 17210-080
- Rekruttering
- Amaral Carvalho Hospital
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Santiago, Chile, 7650568
- Rekruttering
- Clinica Alemana de Santiago
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Las Condes
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Santiago, Las Condes, Chile, 7620157
- Rekruttering
- Hospital Clinico Universidad de Los Andes
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile, 7560907
- Rekruttering
- Centro Oncologia de Precision Universidad Mayor
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Santiago, Santiago Metropolitan, Chile, 7580206
- Rekruttering
- Inmunocel
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Aberdeen, Det Forenede Kongerige, AB25 2ZN
- Rekruttering
- NHS Grampian: Aberdeen Royal Infirmary
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Uxbridge, Det Forenede Kongerige, UB8 3NN
- Rekruttering
- The Hillingdon Hospitals NHS Foundation Trust
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85259
- Rekruttering
- Mayo Clinic - Arizona
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California
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Los Angeles, California, Forenede Stater, 90095
- Rekruttering
- David Geffen School of Medicine at UCLA
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Orange, California, Forenede Stater, 92868
- Rekruttering
- University of California Irvine Medical Center
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Sacramento, California, Forenede Stater, 95817
- Trukket tilbage
- UC Davis Comprehensive Cancer Center
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Florida
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Jacksonville, Florida, Forenede Stater, 32224
- Rekruttering
- Mayo Clinic Jacksonville
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Rekruttering
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center
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Indianapolis, Indiana, Forenede Stater, 46260
- Rekruttering
- St Vincent Ascension at Peyton Manning Childrens Hospital
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Noblesville, Indiana, Forenede Stater, 46062
- Rekruttering
- Investigative Clinical Research of Indiana
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536
- Rekruttering
- University of Kentucky
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- Rekruttering
- University of Maryland Greenebaum Comprehensive Cancer Center
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215
- Rekruttering
- Beth Israel Deaconess Medical Center
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Michigan
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Detroit, Michigan, Forenede Stater, 48202
- Rekruttering
- Henry Ford Health System
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Grand Rapids, Michigan, Forenede Stater, 49503
- Rekruttering
- Cancer and Hematology Centers of Western Michigan
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55901
- Rekruttering
- Mayo Clinic - Rochester
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New Jersey
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New Brunswick, New Jersey, Forenede Stater, 08901
- Rekruttering
- Rutgers Cancer Institute of New Jersey
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New York
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Stony Brook, New York, Forenede Stater, 11794
- Rekruttering
- Stony Brook University Hospital
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Westbury, New York, Forenede Stater, 11590
- Trukket tilbage
- Clinical Research Alliance Inc
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North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Rekruttering
- Duke University Medical Center
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Greenville, North Carolina, Forenede Stater, 27834
- Rekruttering
- East Carolina University
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- Rekruttering
- University Hospitals Cleveland Medical Center
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Texas
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Houston, Texas, Forenede Stater, 77030
- Trukket tilbage
- Center for Oncology and Blood Disorders
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Utah
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Ogden, Utah, Forenede Stater, 84405
- Rekruttering
- Community Cancer Trials of Utah
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Wisconsin
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Waukesha, Wisconsin, Forenede Stater, 53188
- Trukket tilbage
- Prohealth Care Inc
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Angers, Frankrig, 49000
- Trukket tilbage
- Centre Hospitalier Universitaire Angers
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Lyon, Frankrig, 69008
- Rekruttering
- Centre Leon Berard
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Marseille, Frankrig, 130005
- Rekruttering
- Assistance Publique Hopitaux Universitaires de Marseille (AP-HM) Conception
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Metz-Tessy, Frankrig, 74374
- Rekruttering
- Change Annecy
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Nîmes, Frankrig, 30029
- Rekruttering
- CHU Nimes Institut de Cancerologie
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Paris, Frankrig, 75571
- Rekruttering
- Assistance Publique-Hopitaux de Paris (AP-HP)
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Saint-Etienne, Frankrig, 42055
- Rekruttering
- CHU de Saint-Etienne
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Brittany Region
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Quimper, Brittany Region, Frankrig, 29107
- Rekruttering
- Centre Hospitalier de Cornouaille Quimper Concarneau
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Rennes, Brittany Region, Frankrig, 35033
- Rekruttering
- Centre Hospitalier Universitaire (CHU) Rennes
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Centre-Val de Loire
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Tours, Centre-Val de Loire, Frankrig, 37044
- Rekruttering
- CHRU de Tours
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Gironde
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Bordeaux, Gironde, Frankrig, 33077
- Rekruttering
- Polyclinique Bordeaux Nord Aquitaine
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New Aquitaine
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Pessac, New Aquitaine, Frankrig, 33600
- Rekruttering
- Centre Hospitalier Universitaire (CHU) de Bordeaux
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Poitiers, New Aquitaine, Frankrig, 86000
- Rekruttering
- Centre Hospitalier Universitaire De Poitiers
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Nord
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Lille, Nord, Frankrig, 5900
- Rekruttering
- Hopital Saint Vincent-de-Paul
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Pays de la Loire Region
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Nantes, Pays de la Loire Region, Frankrig, 44093
- Rekruttering
- Nantes University Hospital
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Savoie
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Chambéry, Savoie, Frankrig, 73000
- Rekruttering
- Centre Hospitalier Metropole Savoie
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Île-de-France Region
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Argenteuil, Île-de-France Region, Frankrig, 95100
- Rekruttering
- Hopital Victor Dupouy Argenteuil
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Bobigny, Île-de-France Region, Frankrig, 93000
- Trukket tilbage
- Avicenne Hospital
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Villejuif, Île-de-France Region, Frankrig, 94800
- Rekruttering
- Gustave Roussy
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Dublin, Irland, D08
- Trukket tilbage
- St James Hospital and Trinity College Dublin
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Leinster
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Dublin, Leinster, Irland, D09V2N0
- Trukket tilbage
- Beaumont Hospital
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Ashdod, Israel, 7747629
- Rekruttering
- Samson Assuta Ashdod University Hospital
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Haifa, Israel, 31048
- Rekruttering
- Bnai Zion Medical Center
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Jerusalem, Israel, 91200
- Rekruttering
- Hadassah Medical Center
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Nahariya, Israel, 2210001
- Rekruttering
- Galilee Medical Center
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Tel Aviv, Israel, 64239
- Rekruttering
- The Tel Aviv Sourasky Medical Center
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Tel Aviv
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Tel HaShomer, Tel Aviv, Israel, 5265601
- Rekruttering
- The Chaim Sheba Medical Center
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Milan, Italien, 20141
- Rekruttering
- Istituto Europeo di Oncologia
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Milan, Italien, 20162
- Rekruttering
- ASST Grande Ospedale Metropolitano Niguarda - Main Address
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Modena, Italien, 41124
- Rekruttering
- A.O.U. di Modena
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Naples, Italien, 80131
- Rekruttering
- Federico II University
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Novara, Italien, 28100
- Rekruttering
- AOU Maggiore della Carita
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Pavia, Italien, 27100
- Rekruttering
- Fondazione IRCCS Policlinico San Matteo
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Perugia, Italien, 06132
- Rekruttering
- Azienda Ospedaliera di Perugia
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Ravenna, Italien, 48121
- Rekruttering
- Ospedale Santa Maria delle Croci
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Roma, Italien, 00128
- Rekruttering
- Fondazione Policlinico Universitario Campus Bio-Medico
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Turin, Italien, 10126
- Rekruttering
- Hematology - Città della Salute e della Scienza di Torino
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Udine, Italien, 33100
- Rekruttering
- Santa Maria della Misericordia
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Varese, Italien, 21100
- Rekruttering
- Ospedale di Circolo e Fondazione Macchi Varese
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Forli-Cesena
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Meldola, Forli-Cesena, Italien, 47014
- Rekruttering
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
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Monza E Brianza
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Monza, Monza E Brianza, Italien, 20900
- Rekruttering
- ASST Monza Ospedale San Gerardo
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Piedmont
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Turin, Piedmont, Italien, 10137
- Rekruttering
- Azienda Ospedaliera Ordine Mauriziano Torino, Presidio Umberto I of Turin
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
- Rekruttering
- University Malaya Medical Centre
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Pahang
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Kuantan, Pahang, Malaysia, 25200
- Rekruttering
- Hospital Tg Ampuan Afzan
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Sabah
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Kota Kinabalu, Sabah, Malaysia, 88200
- Rekruttering
- Hospital Queen Elizabeth
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Selangor
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Ampang, Selangor, Malaysia, 68000
- Rekruttering
- Hospital Ampang
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Subang Jaya, Selangor, Malaysia, 47500
- Rekruttering
- Subang Jaya Medical Center
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-
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Bydgoszcz, Polen, 85-168
- Trukket tilbage
- Szpital Uniwersytecki Nr2 Bydgoszcz
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Gdansk, Polen, 80-952
- Rekruttering
- Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center
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Lublin, Polen, 20-954
- Rekruttering
- Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
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Warsaw, Polen, 02-781
- Rekruttering
- Narodowy Instytut Onkologii
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Wałbrzych, Polen, 58-300
- Rekruttering
- Szpital Szpecjalistyczny w Walbrzychu
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polen, 30-510
- Rekruttering
- Matopolskie Centrum Medyczne S.C.
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Polen, 50-367
- Rekruttering
- Uniwersytecki Szpital Kliniczny
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Wielkopolska
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Poznan, Wielkopolska, Polen, 60185
- Trukket tilbage
- Pratia Poznan Medical Center
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Skorzewo, Wielkopolska, Polen, 60185
- Rekruttering
- Aidport Sp. z o.o.
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Łódź Voivodeship
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Lodz, Łódź Voivodeship, Polen, 93-510
- Rekruttering
- Wielospecjalistyczne Centrum Onkologii i Traumatologii
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-
-
-
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Singapore, Singapore, 308433
- Rekruttering
- Tan Tock Seng Hospital
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Singapore, Singapore, 119074
- Rekruttering
- National University Hospital Singapore
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Singapore, Singapore, 168583
- Rekruttering
- National Cancer Centre of Singapore
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-
-
-
-
Barcelona, Spanien, 08041
- Rekruttering
- Hospital Sant Pau
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Barcelona, Spanien, 08908
- Rekruttering
- Institut Catala d'Oncologia
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Granada, Spanien, 18014
- Rekruttering
- Hospital Virgen De Las Nieves De Granada
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Madrid, Spanien, 28031
- Rekruttering
- Hospital Universitario Infanta Leonor
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Madrid, Spanien, 28034
- Rekruttering
- Hospital Universitario Ramon y Cajal
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Madrid, Spanien, 28050
- Rekruttering
- Hospital Universitario HM Sanchinarro
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Madrid, Spanien, 28040
- Rekruttering
- Fundacion Jimenez Diaz University Hospital
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Seville, Spanien, 41009
- Rekruttering
- Hospital Universitario Virgen Macarena
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Toledo, Spanien, 45007
- Trukket tilbage
- Hospital General Universitario de Toledo
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Valencia, Spanien, 46026
- Rekruttering
- Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
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Valencia, Spanien, 46017
- Rekruttering
- University Hospital Doctor Peset
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Valencia, Spanien, 46009
- Rekruttering
- Instituto Valenciano de Oncologia
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A Coruna
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Santiago de Compostela, A Coruna, Spanien, 15706
- Rekruttering
- Hospital Clinico Universitario Santiago de Compostela
-
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Andalusia
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Seville, Andalusia, Spanien, 41013
- Rekruttering
- Hospital Universitario Virgen del Rocio
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Balearic Islands
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Palma, Balearic Islands, Spanien, 07120
- Rekruttering
- Son Espases University Hospital
-
-
Barcelona
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Badalona, Barcelona, Spanien, 08916
- Rekruttering
- Institut Catala D'Oncologia - Badalona - Hospital Germans Trias i Pujol
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Sabadell, Barcelona, Spanien, 08208
- Rekruttering
- Hospital Universitari Parc Tauli
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Terrassa, Barcelona, Spanien, 08221
- Rekruttering
- Hospital Universitari Mutua Terrassa
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Cantabria
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Santander, Cantabria, Spanien, 39008
- Rekruttering
- Hospital Universitario Marques de Valdecilla
-
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Galicia
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A Coruña, Galicia, Spanien, 15006
- Rekruttering
- Complejo Hospitalario Universitario de a Coruna
-
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Madrid
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Pozuelo de Alarcón, Madrid, Spanien, 28223
- Rekruttering
- Hospital Universitario Quironsalud Madrid
-
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Navarre
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Pamplona, Navarre, Spanien, 31008
- Rekruttering
- Hospital Universitario de Navarra
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Principality of Asturias
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Oviedo, Principality of Asturias, Spanien, 33011
- Rekruttering
- Hospital Universitario Central de Asturias
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-
-
-
-
Busan, Sydkorea, 49241
- Rekruttering
- Pusan National University Hospital
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Busan, Sydkorea, 47392
- Rekruttering
- Inje University Busan Paik Hospital
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Busan, Sydkorea, 49201
- Rekruttering
- Dong-A University Hospital
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Daegu, Sydkorea, 42601
- Rekruttering
- Keimyung University Dongsan Hospital
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Daegu, Sydkorea, 42415
- Rekruttering
- Yeyungnam University Medical Center
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Seoul, Sydkorea, 05505
- Rekruttering
- Asan Medical Center
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Seoul, Sydkorea, 06351
- Rekruttering
- Samsung Medical Center
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Seoul, Sydkorea, 07345
- Rekruttering
- Yeouido St. Marys Hospital
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Seoul, Sydkorea, 137-701
- Rekruttering
- Seoul St Marys Hospital
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Gyeonggi-do
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Suwon, Gyeonggi-do, Sydkorea, 16247
- Rekruttering
- St. Vincent Hospital - The Catholic University of Korea
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Namdong-Gu
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Incheon, Namdong-Gu, Sydkorea, 21565
- Rekruttering
- Gachon University Gil Medical Center
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-
-
-
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Changhua, Taiwan, 50006
- Rekruttering
- Changhua Christian Hospital
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Kaohsiung City, Taiwan, 80756
- Rekruttering
- Kaohsiung Medical University Hospital
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New Taipei City, Taiwan, 23561
- Rekruttering
- Taipei Medical University - Shuang Ho Hospital
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Taipei, Taiwan, 11490
- Rekruttering
- Tri-Service General Hospital
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Taipei, Taiwan, 00116
- Rekruttering
- Wanfang Hospital
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Taipei, Taiwan, 106
- Rekruttering
- National Taiwan University Hospital
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-
Chiayi County
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Buzi, Chiayi County, Taiwan, 613
- Rekruttering
- Chang Gung Medical Foundation Chia Yi Branch
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Hunan Province
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Taoyuan, Hunan Province, Taiwan, 33305
- Rekruttering
- Chang Gung Memorial Hospital - Linkou Branch
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Kaohsiung
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Niaosong, Kaohsiung, Taiwan, 83301
- Rekruttering
- Chang Gung Medical Foundation Kaohsiung Branch
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-
-
-
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Bangkok, Thailand, 10700
- Rekruttering
- Sriraj Hospital
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Chiang Mai, Thailand, 50200
- Rekruttering
- Chaing Mai University
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Khon Kaen, Thailand, 40002
- Rekruttering
- Faculty of Medicine
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Krung Thep Maha Nakhon [Bangko]
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Bangkok, Krung Thep Maha Nakhon [Bangko], Thailand, 10330
- Rekruttering
- Chulalongkorn University
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-
-
-
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Prague, Tjekkiet, 10034
- Rekruttering
- University Hospital Kralovske Vinohrady
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Prague, Tjekkiet, 12808
- Rekruttering
- Vseobecna Fakultni Nemocnice V Praze
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East Bohemia
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Hradec Králové, East Bohemia, Tjekkiet, 50005
- Rekruttering
- University Hospital Hradec Kralove
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South Moravian
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Brno, South Moravian, Tjekkiet, 62500
- Rekruttering
- University Hospital Brno
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-
-
-
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Istanbul, Tyrkiet (Türkiye), 34418
- Rekruttering
- Istanbul University Istanbul Faculty of Medicine
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Izmir, Tyrkiet (Türkiye), 35340
- Rekruttering
- Dokuz Eylul University
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Izmir, Tyrkiet (Türkiye), 35100
- Rekruttering
- Ege University
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Sakarya, Tyrkiet (Türkiye), 54290
- Rekruttering
- Sakarya University Medical Faculty
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Samsun, Tyrkiet (Türkiye), 55239
- Rekruttering
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
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Ankara
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Yenimahalle, Ankara, Tyrkiet (Türkiye), 06200
- Rekruttering
- Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
-
-
Mersin
-
Mezitli, Mersin, Tyrkiet (Türkiye), 33200
- Rekruttering
- VM Medical Park Mersin Hospital
-
-
Suleymanpasa
-
Tekirdağ, Suleymanpasa, Tyrkiet (Türkiye), 59100
- Rekruttering
- Tekirdag Namik Kemal University Hospital
-
-
Yenimahalle
-
Ankara, Yenimahalle, Tyrkiet (Türkiye), 6500
- Rekruttering
- Gazi University Faculty of Medicine
-
-
-
-
-
Berlin, Tyskland, 10967
- Rekruttering
- Vivantes Klinikum Am Urban
-
Dresden, Tyskland, 01307
- Trukket tilbage
- University Hospital Carl Gustav Carus
-
Kiel, Tyskland, 24116
- Trukket tilbage
- Stadtisches Krankenhaus Kiel
-
-
Baden-Wurttemberg
-
Stuttgart, Baden-Wurttemberg, Tyskland, 70376
- Rekruttering
- Robert-Bosch-Krankenhaus
-
-
Gmund
-
Mutlangen, Gmund, Tyskland, D-73557
- Rekruttering
- Kliniken Ostalb Stauferklinikum Schwab Gmund
-
-
Hesse
-
Frankfurt am Main, Hesse, Tyskland, 15236
- Rekruttering
- Clinic Frankfurt (Oder)
-
-
North Rhine-Westphalia
-
Essen, North Rhine-Westphalia, Tyskland, 45122
- Rekruttering
- University Hospital Essen
-
-
Rhineland-Palatinate
-
Mainz, Rhineland-Palatinate, Tyskland, 55131
- Rekruttering
- Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
-
-
Saarland
-
Homburg, Saarland, Tyskland, 66421
- Rekruttering
- UKS Homburg
-
-
Saxony
-
Dresden, Saxony, Tyskland, 01307
- Rekruttering
- Hematological Praxis Dresden
-
-
-
-
-
Graz, Østrig, 8036
- Rekruttering
- Medical University Graz
-
Vienna, Østrig, 1090
- Rekruttering
- Medical University of Vienna
-
Vienna, Østrig, 1140
- Rekruttering
- Hanusch Krankenhaus
-
Wels, Østrig, 4600
- Rekruttering
- Klinikum Wels-Grieskirchen
-
-
Styria
-
Leoben, Styria, Østrig, 8700
- Rekruttering
- Landeskrankenhaus Hochsteiermark
-
-
Upper Austria
-
Linz, Upper Austria, Østrig, 4020
- Rekruttering
- Kepler University Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Key Inclusion Criteria:
- Previously untreated participants for lymphoma with documented Cluster of Differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL, for whom next available standard of care therapy is not available or deemed ineligible according to the investigator (Part 1A only)
- Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Life expectancy ≥ 12 months
- International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only
- Adequate hematologic and organ function, as defined in the protocol.
Key Exclusion Criteria:
- Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology
- Another active malignancy, significant active disease or medical condition, as described in the protocol
- Peripheral neuropathy Grade ≥3
- Treatment with any systemic anti-lymphoma therapy, except for participants with Relapsed/Refractory (R/R) DLBCL and participants with DLBCL transformed from an indolent lymphoma after treatment with systemic anti-lymphoma therapy.
- Any other therapy or investigational treatment within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment
- Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol
- Allergy/hypersensitivity to study drugs, as described in the protocol
- Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus Disease (COVID-19) infection, uncontrolled infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol.
Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Odronextamab + CHOP
Part 1, includes dose escalation (Part 1A), and randomized exploration of 2 regimens of odronextamab -cyclophosphamide, doxorubicin, vincristine, prednisone (Odro-CHOP) dose optimization (Part 1B). |
Odronextamab will be administered by intravenous (IV) infusion
Andre navne:
Cyclophosphamide will be administered IV as part of chemotherapy
Andre navne:
Doxorubicin will be administered IV as part of chemotherapy
Andre navne:
Vincristine will be administered IV as part of chemotherapy
Andre navne:
Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy
Andre navne:
|
|
Aktiv komparator: Rituximab + CHOP
Part 2 is the randomized controlled portion, participants will receive either Odro-CHOP or R-CHOP. |
Cyclophosphamide will be administered IV as part of chemotherapy
Andre navne:
Doxorubicin will be administered IV as part of chemotherapy
Andre navne:
Vincristine will be administered IV as part of chemotherapy
Andre navne:
Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy
Andre navne:
Rituximab will be administered IV, or subcutaneously (SC)
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Dose Limiting Toxicities (DLTs)
Tidsramme: Up to 35 days
|
Part 1A |
Up to 35 days
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Up to 2 years
|
Part 1 |
Up to 2 years
|
|
Severity of TEAEs
Tidsramme: Up to 2 years
|
Part 1 |
Up to 2 years
|
|
Progression Free Survival (PFS), assessed by Independent Central Review (ICR)
Tidsramme: Up to 5 years
|
Part 2 |
Up to 5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Incidence of TEAEs
Tidsramme: Up to 2 years
|
Part 2 |
Up to 2 years
|
|
Severity of TEAEs
Tidsramme: Up to 2 years
|
Part 2 |
Up to 2 years
|
|
Event-Free Survival (EFS) assessed by ICR
Tidsramme: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Complete Response (CR) assessed by ICR
Tidsramme: Up to 22 weeks
|
Part 2 |
Up to 22 weeks
|
|
Best Overall Response (BOR) as assessed by local investigators
Tidsramme: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
CR as assessed by local investigators
Tidsramme: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
Duration of Response (DOR) as assessed by local investigators
Tidsramme: Up to 5 years
|
Part 1 and Part 2 |
Up to 5 years
|
|
Odronextamab concentrations in serum when administered with CHOP
Tidsramme: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
Occurrence of Anti-Drug Antibodies (ADA) to odronextamab
Tidsramme: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
Magnitude of ADA to odronextamab
Tidsramme: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
PFS assessed by local investigator review
Tidsramme: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
EFS assessed by local investigator review
Tidsramme: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
BOR assessed by ICR
Tidsramme: Up to 22 weeks
|
Part 2 |
Up to 22 weeks
|
|
DOR assessed by ICR
Tidsramme: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Minimal Residual Disease (MRD) status
Tidsramme: Up to 22 weeks
|
Part 2 |
Up to 22 weeks
|
|
Change in physical functioning as measured by European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C) 30
Tidsramme: Up to 5 years
|
Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden. |
Up to 5 years
|
|
Change in patient reported outcomes, as measured by EORTC QLQ-C30
Tidsramme: Up to 5 years
|
Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden. |
Up to 5 years
|
|
Change in patient reported outcomes, as measured by Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS)
Tidsramme: Up to 5 years
|
Part 2 The FACT-Lym lymphoma subscale (LymS) includes 15 items to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). Higher scores are associated with a worse quality of life. |
Up to 5 years
|
|
Change in patient reported outcomes, as measured by Patient Global Impression of Severity (PGIS)
Tidsramme: Up to 5 years
|
Part 2 The PGIS includes a single-item to assess how a patient perceives the overall severity of cancer symptoms over the past 7 days. Patients will choose the response that best describes the severity of their overall cancer symptoms with options on a 5-point scale ranging from 1 (No symptoms) to 4 (Very Severe). |
Up to 5 years
|
|
Change in patient reported outcomes, as measured by Patient Global Impression of Change (PGIC)
Tidsramme: Up to 5 years
|
Part 2 The PGIC item includes a single-item to assess how a patient perceives their overall change in health status since the start of study treatment. Patients will choose from response options on a 7-point scale ranging from 1 (Much Better) to 7 (Much worse); 1- Much Better, 2-Moderately Better, 3-A Little Better, 4-About the Same, 5-A Little Worse, 6-Moderately Worse, 7-Much Worse. |
Up to 5 years
|
|
Change in patient reported outcomes, as measured by EuroQol-5 Dimension-5 Level Scale (EQ-5D-5L)
Tidsramme: Up to 5 years
|
Part 2 The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: "no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems". The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labeled "Best imaginable health state" and "Worst imaginable health state". |
Up to 5 years
|
|
Change in score of the Functional Assessment of Cancer Therapy-General (FACT-G ) GP5 item
Tidsramme: Up to 5 years
|
Part 2 A single item (GP5) of the validated FACT-G questionnaire will be used to assess from the participant perspective the overall impact of treatment side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4). |
Up to 5 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
13. december 2023
Primær færdiggørelse (Anslået)
30. marts 2028
Studieafslutning (Anslået)
12. september 2029
Datoer for studieregistrering
Først indsendt
13. oktober 2023
Først indsendt, der opfyldte QC-kriterier
13. oktober 2023
Først opslået (Faktiske)
19. oktober 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Lymfesygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Lymfom, Non-Hodgkin
- Lymfom, B-celle
- Lymfom
- Hemiske og lymfatiske sygdomme
- Lymfom, stor B-celle, diffus
- Aminosyrer, peptider og proteiner
- Proteiner
- Organiske kemikalier
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Kulbrinter
- Kulbrinter, cyklisk
- Kulhydrater
- Alkaloider
- Polycykliske aromatiske kulbrinter
- Kulbrinter, aromatisk
- Polycykliske forbindelser
- Glycosider
- Indoler
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Gravidier
- Graviditet
- Steroider
- SMUSED-RING-forbindelser
- Fosforamid -sennep
- Nitrogen sennepsforbindelser
- Sennepsforbindelser
- Kulbrinter, halogeneret
- Phosphoramider
- Organophosphorforbindelser
- Gravideretrioler
- Gravideretioler
- Vinca alkaloider
- Secologanin tryptamin alkaloider
- Indole alkaloider
- Indolizidiner
- Indolizines
- Anthracycliner
- Naphthacenes
- Aminoglycosider
- Antistoffer, monoklonal, murint afledt
- Daunorubicin
- Rituximab
- Prednison
- Prednisolon
- Cyclofosfamid
- Doxorubicin
- Vincristine
Andre undersøgelses-id-numre
- R1979-ONC-2105
- 2022-502785-25-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD-delingstidsramme
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
IPD-delingsadgangskriterier
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .