Uno studio per confrontare l'efficacia di Odronextamab combinato con la chemioterapia e la sua sicurezza contro Rituximab combinato con la chemioterapia, in pazienti con linfoma diffuso a grandi cellule B precedentemente non trattato (OLYMPIA-3)
3 novembre 2026 aggiornato da: Regeneron Pharmaceuticals
Uno studio randomizzato di fase 3, in aperto, che confronta l'efficacia e la sicurezza di Odronextamab (REGN1979), un anticorpo bispecifico anti-CD20 × anti-CD3, in combinazione con CHOP (O-CHOP) rispetto a Rituximab in combinazione con CHOP (R-CHOP) ) in partecipanti precedentemente non trattati con linfoma diffuso a grandi cellule 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
Panoramica dello studio
Stato
Reclutamento
Condizioni
Tipo di studio
Interventistico
Iscrizione (Stimato)
904
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Clinical Trials Administrator
- Numero di telefono: 844-734-6643
- Email: clinicaltrials@regeneron.com
Luoghi di studio
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New South Wales
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Liverpool, New South Wales, Australia, 2170
- Reclutamento
- Liverpool Hospital
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Waratah, New South Wales, Australia, 2298
- Reclutamento
- Calvary Mater Newcastle
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Queensland
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Auchenflower, Queensland, Australia, 4066
- Reclutamento
- Icon Cancer Centre - Wesley
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Benowa, Queensland, Australia, 4217
- Reclutamento
- Pindara Private Hospital
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Victoria
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East Melbourne, Victoria, Australia, 3121
- Reclutamento
- Epworth Freemasons
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-
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Graz, Austria, 8036
- Reclutamento
- Medical University Graz
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Vienna, Austria, 1090
- Reclutamento
- Medical University of Vienna
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Vienna, Austria, 1140
- Reclutamento
- Hanusch Krankenhaus
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Wels, Austria, 4600
- Reclutamento
- Klinikum Wels-Grieskirchen
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Styria
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Leoben, Styria, Austria, 8700
- Reclutamento
- Landeskrankenhaus Hochsteiermark
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Upper Austria
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Linz, Upper Austria, Austria, 4020
- Reclutamento
- Kepler University Hospital
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Brussels, Belgio, 1000
- Reclutamento
- Institut Jules Bordet
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Antwerp
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Herentals, Antwerp, Belgio, 2200
- Reclutamento
- AZ St.-Elisabeth Herentals vzw
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Liege
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Verviers, Liege, Belgio, 4800
- Reclutamento
- Centre Hospitalier Regional de Verviers
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgio, 9000
- Reclutamento
- Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
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West-Vlaanderen
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Roeselare, West-Vlaanderen, Belgio, 8800
- Reclutamento
- Algemeen Ziekenhuis AZ Delta
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Rio de Janeiro, Brasile, 22793-334
- Reclutamento
- Instituto Americas
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Rio de Janeiro, Brasile, 20231050
- Reclutamento
- Instituto Nacional de Cancer Jose Alencar Gomes da Silva
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São Paulo, Brasile, 01509-010
- Reclutamento
- AC Camargo Cancer Center
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São Paulo, Brasile, 01323-903
- Reclutamento
- Hospital Alemao Oswaldo Cruz
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São Paulo, Brasile, 05403-000
- Reclutamento
- Clinical Hospital of Medicine School at Sao Paulo University
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São Paulo, Brasile, 08270-070
- Reclutamento
- Casa de Saude Santa Marcelina
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São Paulo, Brasile, 05403-010
- Reclutamento
- 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, Brasile, 41950-640
- Reclutamento
- Ensino e Terapia de Inovacao Clinica Amo (Etica)
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Federal District
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Brasília, Federal District, Brasile, 70200-730
- Reclutamento
- Hospital Sirio Libanes Brasilia
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasile, 30380-472
- Reclutamento
- Instituto Mario Penna de Ensino Pesquisa e Inovacao
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Paraná
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Cascavel, Paraná, Brasile, 85806-300
- Reclutamento
- Uopeccan Hospital do Cancer de Cascavel
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Curitiba, Paraná, Brasile, 81520-060
- Reclutamento
- Hospital Erasto Gaertner
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brasile, 59062-000
- Reclutamento
- Liga Norte Riograndense Contra o Cancer
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-
Rio Grande do Sul
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Bento Gonçalves, Rio Grande do Sul, Brasile, 95700-084
- Reclutamento
- Instituto Tacchini de Pesquisa em Saude
-
Porto Alegre, Rio Grande do Sul, Brasile, 90035-903
- Reclutamento
- Hospital de Clinicas de Porto Alegre
-
Porto Alegre, Rio Grande do Sul, Brasile, 90110-270
- Reclutamento
- Centro Gaucho Integrado
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Santa Catarina
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Joinville, Santa Catarina, Brasile, 89201-260
- Reclutamento
- Centro de Hematologia e Oncologia
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Lages, Santa Catarina, Brasile, 88501-001
- Reclutamento
- Animi Unidade de Tratamento Oncologico Ltda
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São Paulo
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Barretos, São Paulo, Brasile, 14784-400
- Reclutamento
- Fundacao Pio XII - Hospital de Amor
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Jaú, São Paulo, Brasile, 17210-080
- Reclutamento
- Amaral Carvalho Hospital
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-
-
-
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Prague, Cechia, 10034
- Reclutamento
- University Hospital Kralovske Vinohrady
-
Prague, Cechia, 12808
- Reclutamento
- Vseobecna Fakultni Nemocnice V Praze
-
-
East Bohemia
-
Hradec Králové, East Bohemia, Cechia, 50005
- Reclutamento
- University Hospital Hradec Kralove
-
-
South Moravian
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Brno, South Moravian, Cechia, 62500
- Reclutamento
- University Hospital Brno
-
-
-
-
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Santiago, Chile, 7650568
- Reclutamento
- Clinica Alemana de Santiago
-
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Las Condes
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Santiago, Las Condes, Chile, 7620157
- Reclutamento
- Hospital Clinico Universidad de Los Andes
-
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile, 7560907
- Reclutamento
- Centro Oncologia de Precision Universidad Mayor
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Santiago, Santiago Metropolitan, Chile, 7580206
- Reclutamento
- Inmunocel
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-
-
-
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Busan, Corea del Sud, 49241
- Reclutamento
- Pusan National University Hospital
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Busan, Corea del Sud, 47392
- Reclutamento
- Inje University Busan Paik Hospital
-
Busan, Corea del Sud, 49201
- Reclutamento
- Dong-A University Hospital
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Daegu, Corea del Sud, 42601
- Reclutamento
- Keimyung University Dongsan Hospital
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Daegu, Corea del Sud, 42415
- Reclutamento
- Yeyungnam University Medical Center
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Seoul, Corea del Sud, 05505
- Reclutamento
- Asan Medical Center
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Seoul, Corea del Sud, 06351
- Reclutamento
- Samsung Medical Center
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Seoul, Corea del Sud, 07345
- Reclutamento
- Yeouido St. Marys Hospital
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Seoul, Corea del Sud, 137-701
- Reclutamento
- Seoul St Marys Hospital
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Gyeonggi-do
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Suwon, Gyeonggi-do, Corea del Sud, 16247
- Reclutamento
- St. Vincent Hospital - The Catholic University of Korea
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Namdong-Gu
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Incheon, Namdong-Gu, Corea del Sud, 21565
- Reclutamento
- Gachon University Gil Medical Center
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-
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Angers, Francia, 49000
- Ritirato
- Centre Hospitalier Universitaire Angers
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Lyon, Francia, 69008
- Reclutamento
- Centre Leon Berard
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Marseille, Francia, 130005
- Reclutamento
- Assistance Publique Hopitaux Universitaires de Marseille (AP-HM) Conception
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Metz-Tessy, Francia, 74374
- Reclutamento
- Change Annecy
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Nîmes, Francia, 30029
- Reclutamento
- CHU Nimes Institut de Cancerologie
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Paris, Francia, 75571
- Reclutamento
- Assistance Publique-Hopitaux de Paris (AP-HP)
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Saint-Etienne, Francia, 42055
- Reclutamento
- CHU de Saint-Etienne
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Brittany Region
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Quimper, Brittany Region, Francia, 29107
- Reclutamento
- Centre Hospitalier de Cornouaille Quimper Concarneau
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Rennes, Brittany Region, Francia, 35033
- Reclutamento
- Centre Hospitalier Universitaire (CHU) Rennes
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Centre-Val de Loire
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Tours, Centre-Val de Loire, Francia, 37044
- Reclutamento
- CHRU de Tours
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Gironde
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Bordeaux, Gironde, Francia, 33077
- Reclutamento
- Polyclinique Bordeaux Nord Aquitaine
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New Aquitaine
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Pessac, New Aquitaine, Francia, 33600
- Reclutamento
- Centre Hospitalier Universitaire (CHU) de Bordeaux
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Poitiers, New Aquitaine, Francia, 86000
- Reclutamento
- Centre Hospitalier Universitaire De Poitiers
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Nord
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Lille, Nord, Francia, 5900
- Reclutamento
- Hopital Saint Vincent-de-Paul
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Pays de la Loire Region
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Nantes, Pays de la Loire Region, Francia, 44093
- Reclutamento
- Nantes University Hospital
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Savoie
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Chambéry, Savoie, Francia, 73000
- Reclutamento
- Centre Hospitalier Metropole Savoie
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Île-de-France Region
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Argenteuil, Île-de-France Region, Francia, 95100
- Reclutamento
- Hopital Victor Dupouy Argenteuil
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Bobigny, Île-de-France Region, Francia, 93000
- Ritirato
- Avicenne Hospital
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Villejuif, Île-de-France Region, Francia, 94800
- Reclutamento
- Gustave Roussy
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-
-
-
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Berlin, Germania, 10967
- Reclutamento
- Vivantes Klinikum Am Urban
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Dresden, Germania, 01307
- Ritirato
- University Hospital Carl Gustav Carus
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Kiel, Germania, 24116
- Ritirato
- Stadtisches Krankenhaus Kiel
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Baden-Wurttemberg
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Stuttgart, Baden-Wurttemberg, Germania, 70376
- Reclutamento
- Robert-Bosch-Krankenhaus
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Gmund
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Mutlangen, Gmund, Germania, D-73557
- Reclutamento
- Kliniken Ostalb Stauferklinikum Schwab Gmund
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Hesse
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Frankfurt am Main, Hesse, Germania, 15236
- Reclutamento
- Clinic Frankfurt (Oder)
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North Rhine-Westphalia
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Essen, North Rhine-Westphalia, Germania, 45122
- Reclutamento
- University Hospital Essen
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Rhineland-Palatinate
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Mainz, Rhineland-Palatinate, Germania, 55131
- Reclutamento
- Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
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Saarland
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Homburg, Saarland, Germania, 66421
- Reclutamento
- UKS Homburg
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-
Saxony
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Dresden, Saxony, Germania, 01307
- Reclutamento
- Hematological Praxis Dresden
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-
-
-
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Dublin, Irlanda, D08
- Ritirato
- St James Hospital and Trinity College Dublin
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Leinster
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Dublin, Leinster, Irlanda, D09V2N0
- Ritirato
- Beaumont Hospital
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-
-
-
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Ashdod, Israele, 7747629
- Reclutamento
- Samson Assuta Ashdod University Hospital
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Haifa, Israele, 31048
- Reclutamento
- Bnai Zion Medical Center
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Jerusalem, Israele, 91200
- Reclutamento
- Hadassah Medical Center
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Nahariya, Israele, 2210001
- Reclutamento
- Galilee Medical Center
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Tel Aviv, Israele, 64239
- Reclutamento
- The Tel Aviv Sourasky Medical Center
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Tel Aviv
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Tel HaShomer, Tel Aviv, Israele, 5265601
- Reclutamento
- The Chaim Sheba Medical Center
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-
-
-
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Milan, Italia, 20141
- Reclutamento
- Istituto Europeo di Oncologia
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Milan, Italia, 20162
- Reclutamento
- ASST Grande Ospedale Metropolitano Niguarda - Main Address
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Modena, Italia, 41124
- Reclutamento
- A.O.U. di Modena
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Naples, Italia, 80131
- Reclutamento
- Federico II University
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Novara, Italia, 28100
- Reclutamento
- AOU Maggiore della Carita
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Pavia, Italia, 27100
- Reclutamento
- Fondazione IRCCS Policlinico San Matteo
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Perugia, Italia, 06132
- Reclutamento
- Azienda Ospedaliera di Perugia
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Ravenna, Italia, 48121
- Reclutamento
- Ospedale Santa Maria delle Croci
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Roma, Italia, 00128
- Reclutamento
- Fondazione Policlinico Universitario Campus Bio-Medico
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Turin, Italia, 10126
- Reclutamento
- Hematology - Città della Salute e della Scienza di Torino
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Udine, Italia, 33100
- Reclutamento
- Santa Maria della Misericordia
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Varese, Italia, 21100
- Reclutamento
- Ospedale di Circolo e Fondazione Macchi Varese
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Forli-Cesena
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Meldola, Forli-Cesena, Italia, 47014
- Reclutamento
- 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, Italia, 20900
- Reclutamento
- ASST Monza Ospedale San Gerardo
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Piedmont
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Turin, Piedmont, Italia, 10137
- Reclutamento
- 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
- Reclutamento
- University Malaya Medical Centre
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Pahang
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Kuantan, Pahang, Malaysia, 25200
- Reclutamento
- Hospital Tg Ampuan Afzan
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-
Sabah
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Kota Kinabalu, Sabah, Malaysia, 88200
- Reclutamento
- Hospital Queen Elizabeth
-
-
Selangor
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Ampang, Selangor, Malaysia, 68000
- Reclutamento
- Hospital Ampang
-
Subang Jaya, Selangor, Malaysia, 47500
- Reclutamento
- Subang Jaya Medical Center
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-
-
-
-
Bydgoszcz, Polonia, 85-168
- Ritirato
- Szpital Uniwersytecki Nr2 Bydgoszcz
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Gdansk, Polonia, 80-952
- Reclutamento
- Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center
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Lublin, Polonia, 20-954
- Reclutamento
- Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
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Warsaw, Polonia, 02-781
- Reclutamento
- Narodowy Instytut Onkologii
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Wałbrzych, Polonia, 58-300
- Reclutamento
- Szpital Szpecjalistyczny w Walbrzychu
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-
Lesser Poland Voivodeship
-
Krakow, Lesser Poland Voivodeship, Polonia, 30-510
- Reclutamento
- Matopolskie Centrum Medyczne S.C.
-
-
Lower Silesian Voivodeship
-
Wroclaw, Lower Silesian Voivodeship, Polonia, 50-367
- Reclutamento
- Uniwersytecki Szpital Kliniczny
-
-
Wielkopolska
-
Poznan, Wielkopolska, Polonia, 60185
- Ritirato
- Pratia Poznan Medical Center
-
Skorzewo, Wielkopolska, Polonia, 60185
- Reclutamento
- Aidport Sp. z o.o.
-
-
Łódź Voivodeship
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Lodz, Łódź Voivodeship, Polonia, 93-510
- Reclutamento
- Wielospecjalistyczne Centrum Onkologii i Traumatologii
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-
-
-
-
Aberdeen, Regno Unito, AB25 2ZN
- Reclutamento
- NHS Grampian: Aberdeen Royal Infirmary
-
Uxbridge, Regno Unito, UB8 3NN
- Reclutamento
- The Hillingdon Hospitals NHS Foundation Trust
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-
-
-
-
Singapore, Singapore, 308433
- Reclutamento
- Tan Tock Seng Hospital
-
Singapore, Singapore, 119074
- Reclutamento
- National University Hospital Singapore
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Singapore, Singapore, 168583
- Reclutamento
- National Cancer Centre of Singapore
-
-
-
-
-
Barcelona, Spagna, 08041
- Reclutamento
- Hospital Sant Pau
-
Barcelona, Spagna, 08908
- Reclutamento
- Institut Catala d'Oncologia
-
Granada, Spagna, 18014
- Reclutamento
- Hospital Virgen De Las Nieves De Granada
-
Madrid, Spagna, 28031
- Reclutamento
- Hospital Universitario Infanta Leonor
-
Madrid, Spagna, 28034
- Reclutamento
- Hospital Universitario Ramon y Cajal
-
Madrid, Spagna, 28050
- Reclutamento
- Hospital Universitario HM Sanchinarro
-
Madrid, Spagna, 28040
- Reclutamento
- Fundacion Jimenez Diaz University Hospital
-
Seville, Spagna, 41009
- Reclutamento
- Hospital Universitario Virgen Macarena
-
Toledo, Spagna, 45007
- Ritirato
- Hospital General Universitario de Toledo
-
Valencia, Spagna, 46026
- Reclutamento
- Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
-
Valencia, Spagna, 46017
- Reclutamento
- University Hospital Doctor Peset
-
Valencia, Spagna, 46009
- Reclutamento
- Instituto Valenciano de Oncologia
-
-
A Coruna
-
Santiago de Compostela, A Coruna, Spagna, 15706
- Reclutamento
- Hospital Clinico Universitario Santiago de Compostela
-
-
Andalusia
-
Seville, Andalusia, Spagna, 41013
- Reclutamento
- Hospital Universitario Virgen del Rocio
-
-
Balearic Islands
-
Palma, Balearic Islands, Spagna, 07120
- Reclutamento
- Son Espases University Hospital
-
-
Barcelona
-
Badalona, Barcelona, Spagna, 08916
- Reclutamento
- Institut Catala D'Oncologia - Badalona - Hospital Germans Trias i Pujol
-
Sabadell, Barcelona, Spagna, 08208
- Reclutamento
- Hospital Universitari Parc Tauli
-
Terrassa, Barcelona, Spagna, 08221
- Reclutamento
- Hospital Universitari Mutua Terrassa
-
-
Cantabria
-
Santander, Cantabria, Spagna, 39008
- Reclutamento
- Hospital Universitario Marques de Valdecilla
-
-
Galicia
-
A Coruña, Galicia, Spagna, 15006
- Reclutamento
- Complejo Hospitalario Universitario de a Coruna
-
-
Madrid
-
Pozuelo de Alarcón, Madrid, Spagna, 28223
- Reclutamento
- Hospital Universitario Quironsalud Madrid
-
-
Navarre
-
Pamplona, Navarre, Spagna, 31008
- Reclutamento
- Hospital Universitario de Navarra
-
-
Principality of Asturias
-
Oviedo, Principality of Asturias, Spagna, 33011
- Reclutamento
- Hospital Universitario Central de Asturias
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-
-
-
Arizona
-
Scottsdale, Arizona, Stati Uniti, 85259
- Reclutamento
- Mayo Clinic - Arizona
-
-
California
-
Los Angeles, California, Stati Uniti, 90095
- Reclutamento
- David Geffen School of Medicine at UCLA
-
Orange, California, Stati Uniti, 92868
- Reclutamento
- University of California Irvine Medical Center
-
Sacramento, California, Stati Uniti, 95817
- Ritirato
- UC Davis Comprehensive Cancer Center
-
-
Florida
-
Jacksonville, Florida, Stati Uniti, 32224
- Reclutamento
- Mayo Clinic Jacksonville
-
-
Indiana
-
Indianapolis, Indiana, Stati Uniti, 46202
- Reclutamento
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center
-
Indianapolis, Indiana, Stati Uniti, 46260
- Reclutamento
- St Vincent Ascension at Peyton Manning Childrens Hospital
-
Noblesville, Indiana, Stati Uniti, 46062
- Reclutamento
- Investigative Clinical Research of Indiana
-
-
Kentucky
-
Lexington, Kentucky, Stati Uniti, 40536
- Reclutamento
- University of Kentucky
-
-
Maryland
-
Baltimore, Maryland, Stati Uniti, 21201
- Reclutamento
- University of Maryland Greenebaum Comprehensive Cancer Center
-
-
Massachusetts
-
Boston, Massachusetts, Stati Uniti, 02215
- Reclutamento
- Beth Israel Deaconess Medical Center
-
-
Michigan
-
Detroit, Michigan, Stati Uniti, 48202
- Reclutamento
- Henry Ford Health System
-
Grand Rapids, Michigan, Stati Uniti, 49503
- Reclutamento
- Cancer and Hematology Centers of Western Michigan
-
-
Minnesota
-
Rochester, Minnesota, Stati Uniti, 55901
- Reclutamento
- Mayo Clinic - Rochester
-
-
New Jersey
-
New Brunswick, New Jersey, Stati Uniti, 08901
- Reclutamento
- Rutgers Cancer Institute of New Jersey
-
-
New York
-
Stony Brook, New York, Stati Uniti, 11794
- Reclutamento
- Stony Brook University Hospital
-
Westbury, New York, Stati Uniti, 11590
- Ritirato
- Clinical Research Alliance Inc
-
-
North Carolina
-
Durham, North Carolina, Stati Uniti, 27710
- Reclutamento
- Duke University Medical Center
-
Greenville, North Carolina, Stati Uniti, 27834
- Reclutamento
- East Carolina University
-
-
Ohio
-
Cleveland, Ohio, Stati Uniti, 44106
- Reclutamento
- University Hospitals Cleveland Medical Center
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- Ritirato
- Center for Oncology and Blood Disorders
-
-
Utah
-
Ogden, Utah, Stati Uniti, 84405
- Reclutamento
- Community Cancer Trials of Utah
-
-
Wisconsin
-
Waukesha, Wisconsin, Stati Uniti, 53188
- Ritirato
- Prohealth Care Inc
-
-
-
-
-
Bangkok, Tailandia, 10700
- Reclutamento
- Sriraj Hospital
-
Chiang Mai, Tailandia, 50200
- Reclutamento
- Chaing Mai University
-
Khon Kaen, Tailandia, 40002
- Reclutamento
- Faculty of Medicine
-
-
Krung Thep Maha Nakhon [Bangko]
-
Bangkok, Krung Thep Maha Nakhon [Bangko], Tailandia, 10330
- Reclutamento
- Chulalongkorn University
-
-
-
-
-
Changhua, Taiwan, 50006
- Reclutamento
- Changhua Christian Hospital
-
Kaohsiung City, Taiwan, 80756
- Reclutamento
- Kaohsiung Medical University Hospital
-
New Taipei City, Taiwan, 23561
- Reclutamento
- Taipei Medical University - Shuang Ho Hospital
-
Taipei, Taiwan, 11490
- Reclutamento
- Tri-Service General Hospital
-
Taipei, Taiwan, 00116
- Reclutamento
- Wanfang Hospital
-
Taipei, Taiwan, 106
- Reclutamento
- National Taiwan University Hospital
-
-
Chiayi County
-
Buzi, Chiayi County, Taiwan, 613
- Reclutamento
- Chang Gung Medical Foundation Chia Yi Branch
-
-
Hunan Province
-
Taoyuan, Hunan Province, Taiwan, 33305
- Reclutamento
- Chang Gung Memorial Hospital - Linkou Branch
-
-
Kaohsiung
-
Niaosong, Kaohsiung, Taiwan, 83301
- Reclutamento
- Chang Gung Medical Foundation Kaohsiung Branch
-
-
-
-
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Istanbul, Turchia (Türkiye), 34418
- Reclutamento
- Istanbul University Istanbul Faculty of Medicine
-
Izmir, Turchia (Türkiye), 35340
- Reclutamento
- Dokuz Eylul University
-
Izmir, Turchia (Türkiye), 35100
- Reclutamento
- Ege University
-
Sakarya, Turchia (Türkiye), 54290
- Reclutamento
- Sakarya University Medical Faculty
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Samsun, Turchia (Türkiye), 55239
- Reclutamento
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
-
-
Ankara
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Yenimahalle, Ankara, Turchia (Türkiye), 06200
- Reclutamento
- Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
-
-
Mersin
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Mezitli, Mersin, Turchia (Türkiye), 33200
- Reclutamento
- VM Medical Park Mersin Hospital
-
-
Suleymanpasa
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Tekirdağ, Suleymanpasa, Turchia (Türkiye), 59100
- Reclutamento
- Tekirdag Namik Kemal University Hospital
-
-
Yenimahalle
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Ankara, Yenimahalle, Turchia (Türkiye), 6500
- Reclutamento
- Gazi University Faculty of Medicine
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
Altri nomi:
Cyclophosphamide will be administered IV as part of chemotherapy
Altri nomi:
Doxorubicin will be administered IV as part of chemotherapy
Altri nomi:
Vincristine will be administered IV as part of chemotherapy
Altri nomi:
Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy
Altri nomi:
|
|
Comparatore attivo: 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
Altri nomi:
Doxorubicin will be administered IV as part of chemotherapy
Altri nomi:
Vincristine will be administered IV as part of chemotherapy
Altri nomi:
Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy
Altri nomi:
Rituximab will be administered IV, or subcutaneously (SC)
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence of Dose Limiting Toxicities (DLTs)
Lasso di tempo: Up to 35 days
|
Part 1A |
Up to 35 days
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs)
Lasso di tempo: Up to 2 years
|
Part 1 |
Up to 2 years
|
|
Severity of TEAEs
Lasso di tempo: Up to 2 years
|
Part 1 |
Up to 2 years
|
|
Progression Free Survival (PFS), assessed by Independent Central Review (ICR)
Lasso di tempo: Up to 5 years
|
Part 2 |
Up to 5 years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Overall Survival (OS)
Lasso di tempo: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Incidence of TEAEs
Lasso di tempo: Up to 2 years
|
Part 2 |
Up to 2 years
|
|
Severity of TEAEs
Lasso di tempo: Up to 2 years
|
Part 2 |
Up to 2 years
|
|
Event-Free Survival (EFS) assessed by ICR
Lasso di tempo: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Complete Response (CR) assessed by ICR
Lasso di tempo: Up to 22 weeks
|
Part 2 |
Up to 22 weeks
|
|
Best Overall Response (BOR) as assessed by local investigators
Lasso di tempo: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
CR as assessed by local investigators
Lasso di tempo: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
Duration of Response (DOR) as assessed by local investigators
Lasso di tempo: Up to 5 years
|
Part 1 and Part 2 |
Up to 5 years
|
|
Odronextamab concentrations in serum when administered with CHOP
Lasso di tempo: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
Occurrence of Anti-Drug Antibodies (ADA) to odronextamab
Lasso di tempo: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
Magnitude of ADA to odronextamab
Lasso di tempo: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
PFS assessed by local investigator review
Lasso di tempo: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
EFS assessed by local investigator review
Lasso di tempo: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
BOR assessed by ICR
Lasso di tempo: Up to 22 weeks
|
Part 2 |
Up to 22 weeks
|
|
DOR assessed by ICR
Lasso di tempo: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Minimal Residual Disease (MRD) status
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Clinical Trial Management, Regeneron Pharmaceuticals
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
13 dicembre 2023
Completamento primario (Stimato)
30 marzo 2028
Completamento dello studio (Stimato)
12 settembre 2029
Date di iscrizione allo studio
Primo inviato
13 ottobre 2023
Primo inviato che soddisfa i criteri di controllo qualità
13 ottobre 2023
Primo Inserito (Effettivo)
19 ottobre 2023
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
4 novembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 novembre 2026
Ultimo verificato
1 novembre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Malattie linfatiche
- Malattie linfoproliferative
- Disturbi immunoproliferativi
- Linfoma non Hodgkin
- Linfoma, cellule B
- Linfoma
- Malattie emiche e linfatiche
- Linfoma, a grandi cellule B, diffuso
- Aminoacidi, peptidi e proteine
- Proteine
- Prodotti chimici organici
- Composti eterociclici
- Composti eterociclici, 2 anelli
- Composti eterociclici, anello fuso
- Idrocarburi
- Idrocarburi, ciclici
- Carboidrati
- Alcaloidi
- Idrocarburi policiclici aromatici
- Idrocarburi, aromatici
- Composti policiclici
- Glicosidi
- Indoli
- Anticorpi, monoclonali
- Anticorpi
- Immunoglobuline
- Immunoproteine
- Proteine del sangue
- Globuline sieriche
- Globuline
- Incinta
- In gravidanza
- Steroidi
- Composti anelli fusi
- Senape di fosforamide
- Composti di senape di azoto
- Composti di senape
- Idrocarburi, alogenati
- Fosforamidi
- Composti organofosfori
- Incintadienetrioli
- Incintadienediols
- Vinca Alkaloids
- Alcaloidi di triptamina di secologia
- Alcaloidi indolo
- Indolizidine
- Indolizine
- Antracicline
- Naftaceni
- Aminoglicosidi
- Anticorpi, monoclonali, derivati da murina
- Daunorubicina
- Rituximab
- Prednisone
- Prednisolone
- Ciclofosfamide
- Doxorubicina
- Vincristina
Altri numeri di identificazione dello studio
- R1979-ONC-2105
- 2022-502785-25-00 (Ctis)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Periodo di condivisione 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
Criteri di accesso alla condivisione 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
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .