Une étude visant à comparer l'efficacité de l'odronextamab associé à une chimiothérapie et son innocuité par rapport au rituximab associé à une chimiothérapie, chez des patients atteints d'un lymphome diffus à grandes cellules B non traité auparavant (OLYMPIA-3)
3 novembre 2026 mis à jour par: Regeneron Pharmaceuticals
Une étude de phase 3, ouverte et randomisée comparant l'efficacité et l'innocuité de l'odronextamab (REGN1979), un anticorps bispécifique anti-CD20 × anti-CD3, en association avec CHOP (O-CHOP) par rapport au rituximab en association avec CHOP (R-CHOP ) chez des participants non traités auparavant atteints d'un lymphome diffus à grandes cellules B (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
Aperçu de l'étude
Statut
Recrutement
Les conditions
Type d'étude
Interventionnel
Inscription (Estimé)
904
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Clinical Trials Administrator
- Numéro de téléphone: 844-734-6643
- E-mail: clinicaltrials@regeneron.com
Lieux d'étude
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Berlin, Allemagne, 10967
- Recrutement
- Vivantes Klinikum Am Urban
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Dresden, Allemagne, 01307
- Retiré
- University Hospital Carl Gustav Carus
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Kiel, Allemagne, 24116
- Retiré
- Stadtisches Krankenhaus Kiel
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Baden-Wurttemberg
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Stuttgart, Baden-Wurttemberg, Allemagne, 70376
- Recrutement
- Robert-Bosch-Krankenhaus
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Gmund
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Mutlangen, Gmund, Allemagne, D-73557
- Recrutement
- Kliniken Ostalb Stauferklinikum Schwab Gmund
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Hesse
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Frankfurt am Main, Hesse, Allemagne, 15236
- Recrutement
- Clinic Frankfurt (Oder)
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North Rhine-Westphalia
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Essen, North Rhine-Westphalia, Allemagne, 45122
- Recrutement
- University Hospital Essen
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Rhineland-Palatinate
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Mainz, Rhineland-Palatinate, Allemagne, 55131
- Recrutement
- Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
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Saarland
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Homburg, Saarland, Allemagne, 66421
- Recrutement
- UKS Homburg
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Saxony
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Dresden, Saxony, Allemagne, 01307
- Recrutement
- Hematological Praxis Dresden
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New South Wales
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Liverpool, New South Wales, Australie, 2170
- Recrutement
- Liverpool Hospital
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Waratah, New South Wales, Australie, 2298
- Recrutement
- Calvary Mater Newcastle
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Queensland
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Auchenflower, Queensland, Australie, 4066
- Recrutement
- Icon Cancer Centre - Wesley
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Benowa, Queensland, Australie, 4217
- Recrutement
- Pindara Private Hospital
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Victoria
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East Melbourne, Victoria, Australie, 3121
- Recrutement
- Epworth Freemasons
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Brussels, Belgique, 1000
- Recrutement
- Institut Jules Bordet
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Antwerp
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Herentals, Antwerp, Belgique, 2200
- Recrutement
- AZ St.-Elisabeth Herentals vzw
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Liege
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Verviers, Liege, Belgique, 4800
- Recrutement
- Centre Hospitalier Regional de Verviers
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgique, 9000
- Recrutement
- Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
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West-Vlaanderen
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Roeselare, West-Vlaanderen, Belgique, 8800
- Recrutement
- Algemeen Ziekenhuis AZ Delta
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Rio de Janeiro, Brésil, 22793-334
- Recrutement
- Instituto Americas
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Rio de Janeiro, Brésil, 20231050
- Recrutement
- Instituto Nacional de Cancer Jose Alencar Gomes da Silva
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São Paulo, Brésil, 01509-010
- Recrutement
- AC Camargo Cancer Center
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São Paulo, Brésil, 01323-903
- Recrutement
- Hospital Alemao Oswaldo Cruz
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São Paulo, Brésil, 05403-000
- Recrutement
- Clinical Hospital of Medicine School at Sao Paulo University
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São Paulo, Brésil, 08270-070
- Recrutement
- Casa de Saude Santa Marcelina
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São Paulo, Brésil, 05403-010
- Recrutement
- 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, Brésil, 41950-640
- Recrutement
- Ensino e Terapia de Inovacao Clinica Amo (Etica)
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Federal District
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Brasília, Federal District, Brésil, 70200-730
- Recrutement
- Hospital Sirio Libanes Brasilia
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brésil, 30380-472
- Recrutement
- Instituto Mario Penna de Ensino Pesquisa e Inovacao
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Paraná
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Cascavel, Paraná, Brésil, 85806-300
- Recrutement
- Uopeccan Hospital do Cancer de Cascavel
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Curitiba, Paraná, Brésil, 81520-060
- Recrutement
- Hospital Erasto Gaertner
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brésil, 59062-000
- Recrutement
- Liga Norte Riograndense Contra o Cancer
-
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Rio Grande do Sul
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Bento Gonçalves, Rio Grande do Sul, Brésil, 95700-084
- Recrutement
- Instituto Tacchini de Pesquisa em Saude
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Porto Alegre, Rio Grande do Sul, Brésil, 90035-903
- Recrutement
- Hospital de Clinicas de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brésil, 90110-270
- Recrutement
- Centro Gaucho Integrado
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Santa Catarina
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Joinville, Santa Catarina, Brésil, 89201-260
- Recrutement
- Centro de Hematologia e Oncologia
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Lages, Santa Catarina, Brésil, 88501-001
- Recrutement
- Animi Unidade de Tratamento Oncologico Ltda
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São Paulo
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Barretos, São Paulo, Brésil, 14784-400
- Recrutement
- Fundacao Pio XII - Hospital de Amor
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Jaú, São Paulo, Brésil, 17210-080
- Recrutement
- Amaral Carvalho Hospital
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-
-
-
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Santiago, Chili, 7650568
- Recrutement
- Clinica Alemana de Santiago
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Las Condes
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Santiago, Las Condes, Chili, 7620157
- Recrutement
- Hospital Clinico Universidad de Los Andes
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chili, 7560907
- Recrutement
- Centro Oncologia de Precision Universidad Mayor
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Santiago, Santiago Metropolitan, Chili, 7580206
- Recrutement
- Inmunocel
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-
-
-
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Busan, Corée du Sud, 49241
- Recrutement
- Pusan National University Hospital
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Busan, Corée du Sud, 47392
- Recrutement
- Inje University Busan Paik Hospital
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Busan, Corée du Sud, 49201
- Recrutement
- Dong-A University Hospital
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Daegu, Corée du Sud, 42601
- Recrutement
- Keimyung University Dongsan Hospital
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Daegu, Corée du Sud, 42415
- Recrutement
- Yeyungnam University Medical Center
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Seoul, Corée du Sud, 05505
- Recrutement
- Asan Medical Center
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Seoul, Corée du Sud, 06351
- Recrutement
- Samsung Medical Center
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Seoul, Corée du Sud, 07345
- Recrutement
- Yeouido St. Marys Hospital
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Seoul, Corée du Sud, 137-701
- Recrutement
- Seoul St Marys Hospital
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Gyeonggi-do
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Suwon, Gyeonggi-do, Corée du Sud, 16247
- Recrutement
- St. Vincent Hospital - The Catholic University of Korea
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Namdong-Gu
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Incheon, Namdong-Gu, Corée du Sud, 21565
- Recrutement
- Gachon University Gil Medical Center
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-
-
-
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Barcelona, Espagne, 08041
- Recrutement
- Hospital Sant Pau
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Barcelona, Espagne, 08908
- Recrutement
- Institut Catala d'Oncologia
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Granada, Espagne, 18014
- Recrutement
- Hospital Virgen De Las Nieves De Granada
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Madrid, Espagne, 28031
- Recrutement
- Hospital Universitario Infanta Leonor
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Madrid, Espagne, 28034
- Recrutement
- Hospital Universitario Ramon y Cajal
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Madrid, Espagne, 28050
- Recrutement
- Hospital Universitario HM Sanchinarro
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Madrid, Espagne, 28040
- Recrutement
- Fundacion Jimenez Diaz University Hospital
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Seville, Espagne, 41009
- Recrutement
- Hospital Universitario Virgen Macarena
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Toledo, Espagne, 45007
- Retiré
- Hospital General Universitario de Toledo
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Valencia, Espagne, 46026
- Recrutement
- Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
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Valencia, Espagne, 46017
- Recrutement
- University Hospital Doctor Peset
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Valencia, Espagne, 46009
- Recrutement
- Instituto Valenciano de Oncologia
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A Coruna
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Santiago de Compostela, A Coruna, Espagne, 15706
- Recrutement
- Hospital Clinico Universitario Santiago de Compostela
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Andalusia
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Seville, Andalusia, Espagne, 41013
- Recrutement
- Hospital Universitario Virgen del Rocio
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Balearic Islands
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Palma, Balearic Islands, Espagne, 07120
- Recrutement
- Son Espases University Hospital
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Barcelona
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Badalona, Barcelona, Espagne, 08916
- Recrutement
- Institut Catala D'Oncologia - Badalona - Hospital Germans Trias i Pujol
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Sabadell, Barcelona, Espagne, 08208
- Recrutement
- Hospital Universitari Parc Tauli
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Terrassa, Barcelona, Espagne, 08221
- Recrutement
- Hospital Universitari Mutua Terrassa
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Cantabria
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Santander, Cantabria, Espagne, 39008
- Recrutement
- Hospital Universitario Marques de Valdecilla
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Galicia
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A Coruña, Galicia, Espagne, 15006
- Recrutement
- Complejo Hospitalario Universitario de a Coruna
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Madrid
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Pozuelo de Alarcón, Madrid, Espagne, 28223
- Recrutement
- Hospital Universitario Quironsalud Madrid
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Navarre
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Pamplona, Navarre, Espagne, 31008
- Recrutement
- Hospital Universitario de Navarra
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Principality of Asturias
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Oviedo, Principality of Asturias, Espagne, 33011
- Recrutement
- Hospital Universitario Central de Asturias
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-
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Angers, France, 49000
- Retiré
- Centre Hospitalier Universitaire Angers
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Lyon, France, 69008
- Recrutement
- Centre Leon Berard
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Marseille, France, 130005
- Recrutement
- Assistance Publique Hopitaux Universitaires de Marseille (AP-HM) Conception
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Metz-Tessy, France, 74374
- Recrutement
- Change Annecy
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Nîmes, France, 30029
- Recrutement
- CHU Nimes Institut de Cancerologie
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Paris, France, 75571
- Recrutement
- Assistance Publique-Hopitaux de Paris (AP-HP)
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Saint-Etienne, France, 42055
- Recrutement
- CHU de Saint-Etienne
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Brittany Region
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Quimper, Brittany Region, France, 29107
- Recrutement
- Centre Hospitalier de Cornouaille Quimper Concarneau
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Rennes, Brittany Region, France, 35033
- Recrutement
- Centre Hospitalier Universitaire (CHU) Rennes
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Centre-Val de Loire
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Tours, Centre-Val de Loire, France, 37044
- Recrutement
- CHRU de Tours
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Gironde
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Bordeaux, Gironde, France, 33077
- Recrutement
- Polyclinique Bordeaux Nord Aquitaine
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New Aquitaine
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Pessac, New Aquitaine, France, 33600
- Recrutement
- Centre Hospitalier Universitaire (CHU) de Bordeaux
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Poitiers, New Aquitaine, France, 86000
- Recrutement
- Centre Hospitalier Universitaire De Poitiers
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Nord
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Lille, Nord, France, 5900
- Recrutement
- Hopital Saint Vincent-de-Paul
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Pays de la Loire Region
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Nantes, Pays de la Loire Region, France, 44093
- Recrutement
- Nantes University Hospital
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Savoie
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Chambéry, Savoie, France, 73000
- Recrutement
- Centre Hospitalier Metropole Savoie
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Île-de-France Region
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Argenteuil, Île-de-France Region, France, 95100
- Recrutement
- Hopital Victor Dupouy Argenteuil
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Bobigny, Île-de-France Region, France, 93000
- Retiré
- Avicenne Hospital
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Villejuif, Île-de-France Region, France, 94800
- Recrutement
- Gustave Roussy
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-
-
-
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Dublin, Irlande, D08
- Retiré
- St James Hospital and Trinity College Dublin
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Leinster
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Dublin, Leinster, Irlande, D09V2N0
- Retiré
- Beaumont Hospital
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-
-
-
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Ashdod, Israël, 7747629
- Recrutement
- Samson Assuta Ashdod University Hospital
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Haifa, Israël, 31048
- Recrutement
- Bnai Zion Medical Center
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Jerusalem, Israël, 91200
- Recrutement
- Hadassah Medical Center
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Nahariya, Israël, 2210001
- Recrutement
- Galilee Medical Center
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Tel Aviv, Israël, 64239
- Recrutement
- The Tel Aviv Sourasky Medical Center
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Tel Aviv
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Tel HaShomer, Tel Aviv, Israël, 5265601
- Recrutement
- The Chaim Sheba Medical Center
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-
-
-
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Milan, Italie, 20141
- Recrutement
- Istituto Europeo di Oncologia
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Milan, Italie, 20162
- Recrutement
- ASST Grande Ospedale Metropolitano Niguarda - Main Address
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Modena, Italie, 41124
- Recrutement
- A.O.U. di Modena
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Naples, Italie, 80131
- Recrutement
- Federico II University
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Novara, Italie, 28100
- Recrutement
- AOU Maggiore della Carita
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Pavia, Italie, 27100
- Recrutement
- Fondazione IRCCS Policlinico San Matteo
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Perugia, Italie, 06132
- Recrutement
- Azienda Ospedaliera di Perugia
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Ravenna, Italie, 48121
- Recrutement
- Ospedale Santa Maria delle Croci
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Roma, Italie, 00128
- Recrutement
- Fondazione Policlinico Universitario Campus Bio-Medico
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Turin, Italie, 10126
- Recrutement
- Hematology - Città della Salute e della Scienza di Torino
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Udine, Italie, 33100
- Recrutement
- Santa Maria della Misericordia
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Varese, Italie, 21100
- Recrutement
- Ospedale di Circolo e Fondazione Macchi Varese
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Forli-Cesena
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Meldola, Forli-Cesena, Italie, 47014
- Recrutement
- 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, Italie, 20900
- Recrutement
- ASST Monza Ospedale San Gerardo
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Piedmont
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Turin, Piedmont, Italie, 10137
- Recrutement
- Azienda Ospedaliera Ordine Mauriziano Torino, Presidio Umberto I of Turin
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-
-
-
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Graz, L'Autriche, 8036
- Recrutement
- Medical University Graz
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Vienna, L'Autriche, 1090
- Recrutement
- Medical University of Vienna
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Vienna, L'Autriche, 1140
- Recrutement
- Hanusch Krankenhaus
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Wels, L'Autriche, 4600
- Recrutement
- Klinikum Wels-Grieskirchen
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Styria
-
Leoben, Styria, L'Autriche, 8700
- Recrutement
- Landeskrankenhaus Hochsteiermark
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Upper Austria
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Linz, Upper Austria, L'Autriche, 4020
- Recrutement
- Kepler University Hospital
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-
-
-
Kuala Lumpur
-
Kuala Lumpur, Kuala Lumpur, Malaisie, 59100
- Recrutement
- University Malaya Medical Centre
-
-
Pahang
-
Kuantan, Pahang, Malaisie, 25200
- Recrutement
- Hospital Tg Ampuan Afzan
-
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Sabah
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Kota Kinabalu, Sabah, Malaisie, 88200
- Recrutement
- Hospital Queen Elizabeth
-
-
Selangor
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Ampang, Selangor, Malaisie, 68000
- Recrutement
- Hospital Ampang
-
Subang Jaya, Selangor, Malaisie, 47500
- Recrutement
- Subang Jaya Medical Center
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-
-
-
-
Bydgoszcz, Pologne, 85-168
- Retiré
- Szpital Uniwersytecki Nr2 Bydgoszcz
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Gdansk, Pologne, 80-952
- Recrutement
- Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center
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Lublin, Pologne, 20-954
- Recrutement
- Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
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Warsaw, Pologne, 02-781
- Recrutement
- Narodowy Instytut Onkologii
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Wałbrzych, Pologne, 58-300
- Recrutement
- Szpital Szpecjalistyczny w Walbrzychu
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Pologne, 30-510
- Recrutement
- Matopolskie Centrum Medyczne S.C.
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Pologne, 50-367
- Recrutement
- Uniwersytecki Szpital Kliniczny
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Wielkopolska
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Poznan, Wielkopolska, Pologne, 60185
- Retiré
- Pratia Poznan Medical Center
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Skorzewo, Wielkopolska, Pologne, 60185
- Recrutement
- Aidport Sp. z o.o.
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Łódź Voivodeship
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Lodz, Łódź Voivodeship, Pologne, 93-510
- Recrutement
- Wielospecjalistyczne Centrum Onkologii i Traumatologii
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-
-
-
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Aberdeen, Royaume-Uni, AB25 2ZN
- Recrutement
- NHS Grampian: Aberdeen Royal Infirmary
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Uxbridge, Royaume-Uni, UB8 3NN
- Recrutement
- The Hillingdon Hospitals NHS Foundation Trust
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-
-
-
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Singapore, Singapour, 308433
- Recrutement
- Tan Tock Seng Hospital
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Singapore, Singapour, 119074
- Recrutement
- National University Hospital Singapore
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Singapore, Singapour, 168583
- Recrutement
- National Cancer Centre of Singapore
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-
-
-
-
Changhua, Taïwan, 50006
- Recrutement
- Changhua Christian Hospital
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Kaohsiung City, Taïwan, 80756
- Recrutement
- Kaohsiung Medical University Hospital
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New Taipei City, Taïwan, 23561
- Recrutement
- Taipei Medical University - Shuang Ho Hospital
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Taipei, Taïwan, 11490
- Recrutement
- Tri-Service General Hospital
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Taipei, Taïwan, 00116
- Recrutement
- Wanfang Hospital
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Taipei, Taïwan, 106
- Recrutement
- National Taiwan University Hospital
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Chiayi County
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Buzi, Chiayi County, Taïwan, 613
- Recrutement
- Chang Gung Medical Foundation Chia Yi Branch
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Hunan Province
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Taoyuan, Hunan Province, Taïwan, 33305
- Recrutement
- Chang Gung Memorial Hospital - Linkou Branch
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Kaohsiung
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Niaosong, Kaohsiung, Taïwan, 83301
- Recrutement
- Chang Gung Medical Foundation Kaohsiung Branch
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-
-
-
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Prague, Tchéquie, 10034
- Recrutement
- University Hospital Kralovske Vinohrady
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Prague, Tchéquie, 12808
- Recrutement
- Vseobecna Fakultni Nemocnice V Praze
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East Bohemia
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Hradec Králové, East Bohemia, Tchéquie, 50005
- Recrutement
- University Hospital Hradec Kralove
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South Moravian
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Brno, South Moravian, Tchéquie, 62500
- Recrutement
- University Hospital Brno
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-
-
-
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Bangkok, Thaïlande, 10700
- Recrutement
- Sriraj Hospital
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Chiang Mai, Thaïlande, 50200
- Recrutement
- Chaing Mai University
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Khon Kaen, Thaïlande, 40002
- Recrutement
- Faculty of Medicine
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Krung Thep Maha Nakhon [Bangko]
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Bangkok, Krung Thep Maha Nakhon [Bangko], Thaïlande, 10330
- Recrutement
- Chulalongkorn University
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-
-
-
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Istanbul, Turquie (Türkiye), 34418
- Recrutement
- Istanbul University Istanbul Faculty of Medicine
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Izmir, Turquie (Türkiye), 35340
- Recrutement
- Dokuz Eylul University
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Izmir, Turquie (Türkiye), 35100
- Recrutement
- Ege University
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Sakarya, Turquie (Türkiye), 54290
- Recrutement
- Sakarya University Medical Faculty
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Samsun, Turquie (Türkiye), 55239
- Recrutement
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
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Ankara
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Yenimahalle, Ankara, Turquie (Türkiye), 06200
- Recrutement
- Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
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Mersin
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Mezitli, Mersin, Turquie (Türkiye), 33200
- Recrutement
- VM Medical Park Mersin Hospital
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Suleymanpasa
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Tekirdağ, Suleymanpasa, Turquie (Türkiye), 59100
- Recrutement
- Tekirdag Namik Kemal University Hospital
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Yenimahalle
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Ankara, Yenimahalle, Turquie (Türkiye), 6500
- Recrutement
- Gazi University Faculty of Medicine
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Arizona
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Scottsdale, Arizona, États-Unis, 85259
- Recrutement
- Mayo Clinic - Arizona
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California
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Los Angeles, California, États-Unis, 90095
- Recrutement
- David Geffen School of Medicine at UCLA
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Orange, California, États-Unis, 92868
- Recrutement
- University of California Irvine Medical Center
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Sacramento, California, États-Unis, 95817
- Retiré
- UC Davis Comprehensive Cancer Center
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Florida
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Jacksonville, Florida, États-Unis, 32224
- Recrutement
- Mayo Clinic Jacksonville
-
-
Indiana
-
Indianapolis, Indiana, États-Unis, 46202
- Recrutement
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center
-
Indianapolis, Indiana, États-Unis, 46260
- Recrutement
- St Vincent Ascension at Peyton Manning Childrens Hospital
-
Noblesville, Indiana, États-Unis, 46062
- Recrutement
- Investigative Clinical Research of Indiana
-
-
Kentucky
-
Lexington, Kentucky, États-Unis, 40536
- Recrutement
- University of Kentucky
-
-
Maryland
-
Baltimore, Maryland, États-Unis, 21201
- Recrutement
- University of Maryland Greenebaum Comprehensive Cancer Center
-
-
Massachusetts
-
Boston, Massachusetts, États-Unis, 02215
- Recrutement
- Beth Israel Deaconess Medical Center
-
-
Michigan
-
Detroit, Michigan, États-Unis, 48202
- Recrutement
- Henry Ford Health System
-
Grand Rapids, Michigan, États-Unis, 49503
- Recrutement
- Cancer and Hematology Centers of Western Michigan
-
-
Minnesota
-
Rochester, Minnesota, États-Unis, 55901
- Recrutement
- Mayo Clinic - Rochester
-
-
New Jersey
-
New Brunswick, New Jersey, États-Unis, 08901
- Recrutement
- Rutgers Cancer Institute of New Jersey
-
-
New York
-
Stony Brook, New York, États-Unis, 11794
- Recrutement
- Stony Brook University Hospital
-
Westbury, New York, États-Unis, 11590
- Retiré
- Clinical Research Alliance Inc
-
-
North Carolina
-
Durham, North Carolina, États-Unis, 27710
- Recrutement
- Duke University Medical Center
-
Greenville, North Carolina, États-Unis, 27834
- Recrutement
- East Carolina University
-
-
Ohio
-
Cleveland, Ohio, États-Unis, 44106
- Recrutement
- University Hospitals Cleveland Medical Center
-
-
Texas
-
Houston, Texas, États-Unis, 77030
- Retiré
- Center for Oncology and Blood Disorders
-
-
Utah
-
Ogden, Utah, États-Unis, 84405
- Recrutement
- Community Cancer Trials of Utah
-
-
Wisconsin
-
Waukesha, Wisconsin, États-Unis, 53188
- Retiré
- Prohealth Care Inc
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
Autres noms:
Cyclophosphamide will be administered IV as part of chemotherapy
Autres noms:
Doxorubicin will be administered IV as part of chemotherapy
Autres noms:
Vincristine will be administered IV as part of chemotherapy
Autres noms:
Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy
Autres noms:
|
|
Comparateur actif: 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
Autres noms:
Doxorubicin will be administered IV as part of chemotherapy
Autres noms:
Vincristine will be administered IV as part of chemotherapy
Autres noms:
Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy
Autres noms:
Rituximab will be administered IV, or subcutaneously (SC)
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of Dose Limiting Toxicities (DLTs)
Délai: Up to 35 days
|
Part 1A |
Up to 35 days
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs)
Délai: Up to 2 years
|
Part 1 |
Up to 2 years
|
|
Severity of TEAEs
Délai: Up to 2 years
|
Part 1 |
Up to 2 years
|
|
Progression Free Survival (PFS), assessed by Independent Central Review (ICR)
Délai: Up to 5 years
|
Part 2 |
Up to 5 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Survival (OS)
Délai: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Incidence of TEAEs
Délai: Up to 2 years
|
Part 2 |
Up to 2 years
|
|
Severity of TEAEs
Délai: Up to 2 years
|
Part 2 |
Up to 2 years
|
|
Event-Free Survival (EFS) assessed by ICR
Délai: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Complete Response (CR) assessed by ICR
Délai: Up to 22 weeks
|
Part 2 |
Up to 22 weeks
|
|
Best Overall Response (BOR) as assessed by local investigators
Délai: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
CR as assessed by local investigators
Délai: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
Duration of Response (DOR) as assessed by local investigators
Délai: Up to 5 years
|
Part 1 and Part 2 |
Up to 5 years
|
|
Odronextamab concentrations in serum when administered with CHOP
Délai: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
Occurrence of Anti-Drug Antibodies (ADA) to odronextamab
Délai: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
Magnitude of ADA to odronextamab
Délai: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
PFS assessed by local investigator review
Délai: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
EFS assessed by local investigator review
Délai: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
BOR assessed by ICR
Délai: Up to 22 weeks
|
Part 2 |
Up to 22 weeks
|
|
DOR assessed by ICR
Délai: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Minimal Residual Disease (MRD) status
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Clinical Trial Management, Regeneron Pharmaceuticals
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
13 décembre 2023
Achèvement primaire (Estimé)
30 mars 2028
Achèvement de l'étude (Estimé)
12 septembre 2029
Dates d'inscription aux études
Première soumission
13 octobre 2023
Première soumission répondant aux critères de contrôle qualité
13 octobre 2023
Première publication (Réel)
19 octobre 2023
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 novembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 novembre 2026
Dernière vérification
1 novembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs
- Maladies du système immunitaire
- Tumeurs par type histologique
- Maladies lymphatiques
- Troubles lymphoprolifératifs
- Troubles immunoprolifératifs
- Lymphome non hodgkinien
- Lymphome à cellules B
- Lymphome
- Maladies hémiques et lymphatiques
- Lymphome diffus à grandes cellules B
- Acides aminés, peptides et protéines
- Protéines
- Produits chimiques organiques
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Hydrocarbures
- Hydrocarbures, cyclique
- Glucides
- Alcaloïdes
- Hydrocarbures aromatiques polycycliques
- Hydrocarbures, aromatique
- Composés polycycliques
- Glycosides
- Indoles
- Anticorps, monoclonal
- Anticorps
- Immunoglobulines
- Immunoprotéines
- Protéines sanguines
- Globulines sériques
- Globulines
- Prégnades
- Grossesse
- Stéroïdes
- Composés à anneau fusionné
- Moutards phosphoramides
- Composés de moutarde d'azote
- Composés moutarde
- Hydrocarbures, halogénés
- Phosphoramides
- Composés organophosphores
- Grossissement
- Grossissements
- Alcaloïdes Vinca
- Alcaloïdes de la secologane tryptamine
- Alcaloïdes indole
- Indolizidines
- Indolizines
- Anthracyclines
- Naphtacènes
- Aminoglycosides
- Anticorps, monoclonal et murin
- Daunorubicine
- Rituximab
- Prednisone
- Prednisolone
- Cyclophosphamide
- Doxorubicine
- Vincristine
Autres numéros d'identification d'étude
- R1979-ONC-2105
- 2022-502785-25-00 (Ctis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Délai de partage IPD
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
Critères d'accès au partage IPD
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
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .