Een onderzoek om te vergelijken hoe goed Odronextamab in combinatie met chemotherapie werkt en hoe veilig het is tegen Rituximab in combinatie met chemotherapie, bij patiënten met niet eerder behandeld diffuus grootcellig B-cellymfoom (OLYMPIA-3)
3 november 2026 bijgewerkt door: Regeneron Pharmaceuticals
Een fase 3, open label, gerandomiseerde studie waarin de werkzaamheid en veiligheid worden vergeleken van odronextamab (REGN1979), een anti-CD20 × anti-CD3 bispecifiek antilichaam, in combinatie met CHOP (O-CHOP) versus rituximab in combinatie met CHOP (R-CHOP) ) bij niet eerder behandelde deelnemers met diffuus grootcellig B-cellymfoom (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
Studie Overzicht
Toestand
Werving
Studietype
Ingrijpend
Inschrijving (Geschat)
904
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Clinical Trials Administrator
- Telefoonnummer: 844-734-6643
- E-mail: clinicaltrials@regeneron.com
Studie Locaties
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New South Wales
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Liverpool, New South Wales, Australië, 2170
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- Liverpool Hospital
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Waratah, New South Wales, Australië, 2298
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- Calvary Mater Newcastle
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Queensland
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Auchenflower, Queensland, Australië, 4066
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- Icon Cancer Centre - Wesley
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Benowa, Queensland, Australië, 4217
- Werving
- Pindara Private Hospital
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Victoria
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East Melbourne, Victoria, Australië, 3121
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- Epworth Freemasons
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Brussels, België, 1000
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- Institut Jules Bordet
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Antwerp
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Herentals, Antwerp, België, 2200
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- AZ St.-Elisabeth Herentals vzw
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Liege
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Verviers, Liege, België, 4800
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- Centre Hospitalier Regional de Verviers
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, België, 9000
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- Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
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West-Vlaanderen
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Roeselare, West-Vlaanderen, België, 8800
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- Algemeen Ziekenhuis AZ Delta
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Rio de Janeiro, Brazilië, 22793-334
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- Instituto Americas
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Rio de Janeiro, Brazilië, 20231050
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- Instituto Nacional de Cancer Jose Alencar Gomes da Silva
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São Paulo, Brazilië, 01509-010
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- AC Camargo Cancer Center
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São Paulo, Brazilië, 01323-903
- Werving
- Hospital Alemao Oswaldo Cruz
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São Paulo, Brazilië, 05403-000
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- Clinical Hospital of Medicine School at Sao Paulo University
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São Paulo, Brazilië, 08270-070
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- Casa de Saude Santa Marcelina
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São Paulo, Brazilië, 05403-010
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- 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, Brazilië, 41950-640
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- Ensino e Terapia de Inovacao Clinica Amo (Etica)
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Federal District
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Brasília, Federal District, Brazilië, 70200-730
- Werving
- Hospital Sirio Libanes Brasilia
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazilië, 30380-472
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- Instituto Mario Penna de Ensino Pesquisa e Inovacao
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Paraná
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Cascavel, Paraná, Brazilië, 85806-300
- Werving
- Uopeccan Hospital do Cancer de Cascavel
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Curitiba, Paraná, Brazilië, 81520-060
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- Hospital Erasto Gaertner
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brazilië, 59062-000
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- Liga Norte Riograndense Contra o Cancer
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Rio Grande do Sul
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Bento Gonçalves, Rio Grande do Sul, Brazilië, 95700-084
- Werving
- Instituto Tacchini de Pesquisa em Saude
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Porto Alegre, Rio Grande do Sul, Brazilië, 90035-903
- Werving
- Hospital de Clinicas de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brazilië, 90110-270
- Werving
- Centro Gaucho Integrado
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Santa Catarina
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Joinville, Santa Catarina, Brazilië, 89201-260
- Werving
- Centro de Hematologia e Oncologia
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Lages, Santa Catarina, Brazilië, 88501-001
- Werving
- Animi Unidade de Tratamento Oncologico Ltda
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São Paulo
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Barretos, São Paulo, Brazilië, 14784-400
- Werving
- Fundacao Pio XII - Hospital de Amor
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Jaú, São Paulo, Brazilië, 17210-080
- Werving
- Amaral Carvalho Hospital
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Santiago, Chili, 7650568
- Werving
- Clinica Alemana de Santiago
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Las Condes
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Santiago, Las Condes, Chili, 7620157
- Werving
- Hospital Clinico Universidad de Los Andes
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chili, 7560907
- Werving
- Centro Oncologia de Precision Universidad Mayor
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Santiago, Santiago Metropolitan, Chili, 7580206
- Werving
- Inmunocel
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Berlin, Duitsland, 10967
- Werving
- Vivantes Klinikum Am Urban
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Dresden, Duitsland, 01307
- Ingetrokken
- University Hospital Carl Gustav Carus
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Kiel, Duitsland, 24116
- Ingetrokken
- Stadtisches Krankenhaus Kiel
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Baden-Wurttemberg
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Stuttgart, Baden-Wurttemberg, Duitsland, 70376
- Werving
- Robert-Bosch-Krankenhaus
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Gmund
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Mutlangen, Gmund, Duitsland, D-73557
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- Kliniken Ostalb Stauferklinikum Schwab Gmund
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Hesse
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Frankfurt am Main, Hesse, Duitsland, 15236
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- Clinic Frankfurt (Oder)
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North Rhine-Westphalia
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Essen, North Rhine-Westphalia, Duitsland, 45122
- Werving
- University Hospital Essen
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Rhineland-Palatinate
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Mainz, Rhineland-Palatinate, Duitsland, 55131
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- Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
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Saarland
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Homburg, Saarland, Duitsland, 66421
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- UKS Homburg
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Saxony
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Dresden, Saxony, Duitsland, 01307
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- Hematological Praxis Dresden
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Angers, Frankrijk, 49000
- Ingetrokken
- Centre Hospitalier Universitaire Angers
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Lyon, Frankrijk, 69008
- Werving
- Centre Leon Berard
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Marseille, Frankrijk, 130005
- Werving
- Assistance Publique Hopitaux Universitaires de Marseille (AP-HM) Conception
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Metz-Tessy, Frankrijk, 74374
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- Change Annecy
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Nîmes, Frankrijk, 30029
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- CHU Nimes Institut de Cancerologie
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Paris, Frankrijk, 75571
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- Assistance Publique-Hopitaux de Paris (AP-HP)
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Saint-Etienne, Frankrijk, 42055
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- CHU de Saint-Etienne
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Brittany Region
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Quimper, Brittany Region, Frankrijk, 29107
- Werving
- Centre Hospitalier de Cornouaille Quimper Concarneau
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Rennes, Brittany Region, Frankrijk, 35033
- Werving
- Centre Hospitalier Universitaire (CHU) Rennes
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Centre-Val de Loire
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Tours, Centre-Val de Loire, Frankrijk, 37044
- Werving
- CHRU de Tours
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Gironde
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Bordeaux, Gironde, Frankrijk, 33077
- Werving
- Polyclinique Bordeaux Nord Aquitaine
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New Aquitaine
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Pessac, New Aquitaine, Frankrijk, 33600
- Werving
- Centre Hospitalier Universitaire (CHU) de Bordeaux
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Poitiers, New Aquitaine, Frankrijk, 86000
- Werving
- Centre Hospitalier Universitaire De Poitiers
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Nord
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Lille, Nord, Frankrijk, 5900
- Werving
- Hopital Saint Vincent-de-Paul
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Pays de la Loire Region
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Nantes, Pays de la Loire Region, Frankrijk, 44093
- Werving
- Nantes University Hospital
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Savoie
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Chambéry, Savoie, Frankrijk, 73000
- Werving
- Centre Hospitalier Metropole Savoie
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Île-de-France Region
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Argenteuil, Île-de-France Region, Frankrijk, 95100
- Werving
- Hopital Victor Dupouy Argenteuil
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Bobigny, Île-de-France Region, Frankrijk, 93000
- Ingetrokken
- Avicenne Hospital
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Villejuif, Île-de-France Region, Frankrijk, 94800
- Werving
- Gustave Roussy
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Dublin, Ierland, D08
- Ingetrokken
- St James Hospital and Trinity College Dublin
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Leinster
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Dublin, Leinster, Ierland, D09V2N0
- Ingetrokken
- Beaumont Hospital
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Ashdod, Israël, 7747629
- Werving
- Samson Assuta Ashdod University Hospital
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Haifa, Israël, 31048
- Werving
- Bnai Zion Medical Center
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Jerusalem, Israël, 91200
- Werving
- Hadassah Medical Center
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Nahariya, Israël, 2210001
- Werving
- Galilee Medical Center
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Tel Aviv, Israël, 64239
- Werving
- The Tel Aviv Sourasky Medical Center
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Tel Aviv
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Tel HaShomer, Tel Aviv, Israël, 5265601
- Werving
- The Chaim Sheba Medical Center
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Milan, Italië, 20141
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- Istituto Europeo di Oncologia
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Milan, Italië, 20162
- Werving
- ASST Grande Ospedale Metropolitano Niguarda - Main Address
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Modena, Italië, 41124
- Werving
- A.O.U. di Modena
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Naples, Italië, 80131
- Werving
- Federico II University
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Novara, Italië, 28100
- Werving
- AOU Maggiore della Carita
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Pavia, Italië, 27100
- Werving
- Fondazione IRCCS Policlinico San Matteo
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Perugia, Italië, 06132
- Werving
- Azienda Ospedaliera di Perugia
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Ravenna, Italië, 48121
- Werving
- Ospedale Santa Maria delle Croci
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Roma, Italië, 00128
- Werving
- Fondazione Policlinico Universitario Campus Bio-Medico
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Turin, Italië, 10126
- Werving
- Hematology - Città della Salute e della Scienza di Torino
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Udine, Italië, 33100
- Werving
- Santa Maria della Misericordia
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Varese, Italië, 21100
- Werving
- Ospedale di Circolo e Fondazione Macchi Varese
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Forli-Cesena
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Meldola, Forli-Cesena, Italië, 47014
- Werving
- 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, Italië, 20900
- Werving
- ASST Monza Ospedale San Gerardo
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Piedmont
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Turin, Piedmont, Italië, 10137
- Werving
- Azienda Ospedaliera Ordine Mauriziano Torino, Presidio Umberto I of Turin
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Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Maleisië, 59100
- Werving
- University Malaya Medical Centre
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Pahang
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Kuantan, Pahang, Maleisië, 25200
- Werving
- Hospital Tg Ampuan Afzan
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Sabah
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Kota Kinabalu, Sabah, Maleisië, 88200
- Werving
- Hospital Queen Elizabeth
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Selangor
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Ampang, Selangor, Maleisië, 68000
- Werving
- Hospital Ampang
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Subang Jaya, Selangor, Maleisië, 47500
- Werving
- Subang Jaya Medical Center
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Graz, Oostenrijk, 8036
- Werving
- Medical University Graz
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Vienna, Oostenrijk, 1090
- Werving
- Medical University of Vienna
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Vienna, Oostenrijk, 1140
- Werving
- Hanusch Krankenhaus
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Wels, Oostenrijk, 4600
- Werving
- Klinikum Wels-Grieskirchen
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Styria
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Leoben, Styria, Oostenrijk, 8700
- Werving
- Landeskrankenhaus Hochsteiermark
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Upper Austria
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Linz, Upper Austria, Oostenrijk, 4020
- Werving
- Kepler University Hospital
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Bydgoszcz, Polen, 85-168
- Ingetrokken
- Szpital Uniwersytecki Nr2 Bydgoszcz
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Gdansk, Polen, 80-952
- Werving
- Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center
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Lublin, Polen, 20-954
- Werving
- Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
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Warsaw, Polen, 02-781
- Werving
- Narodowy Instytut Onkologii
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Wałbrzych, Polen, 58-300
- Werving
- Szpital Szpecjalistyczny w Walbrzychu
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polen, 30-510
- Werving
- Matopolskie Centrum Medyczne S.C.
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Polen, 50-367
- Werving
- Uniwersytecki Szpital Kliniczny
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Wielkopolska
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Poznan, Wielkopolska, Polen, 60185
- Ingetrokken
- Pratia Poznan Medical Center
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Skorzewo, Wielkopolska, Polen, 60185
- Werving
- Aidport Sp. z o.o.
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Łódź Voivodeship
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Lodz, Łódź Voivodeship, Polen, 93-510
- Werving
- Wielospecjalistyczne Centrum Onkologii i Traumatologii
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Singapore, Singapore, 308433
- Werving
- Tan Tock Seng Hospital
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Singapore, Singapore, 119074
- Werving
- National University Hospital Singapore
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Singapore, Singapore, 168583
- Werving
- National Cancer Centre of Singapore
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Barcelona, Spanje, 08041
- Werving
- Hospital Sant Pau
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Barcelona, Spanje, 08908
- Werving
- Institut Catala d'Oncologia
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Granada, Spanje, 18014
- Werving
- Hospital Virgen De Las Nieves De Granada
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Madrid, Spanje, 28031
- Werving
- Hospital Universitario Infanta Leonor
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Madrid, Spanje, 28034
- Werving
- Hospital Universitario Ramon y Cajal
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Madrid, Spanje, 28050
- Werving
- Hospital Universitario HM Sanchinarro
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Madrid, Spanje, 28040
- Werving
- Fundacion Jimenez Diaz University Hospital
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Seville, Spanje, 41009
- Werving
- Hospital Universitario Virgen Macarena
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Toledo, Spanje, 45007
- Ingetrokken
- Hospital General Universitario de Toledo
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Valencia, Spanje, 46026
- Werving
- Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
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Valencia, Spanje, 46017
- Werving
- University Hospital Doctor Peset
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Valencia, Spanje, 46009
- Werving
- Instituto Valenciano de Oncologia
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A Coruna
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Santiago de Compostela, A Coruna, Spanje, 15706
- Werving
- Hospital Clinico Universitario Santiago de Compostela
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Andalusia
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Seville, Andalusia, Spanje, 41013
- Werving
- Hospital Universitario Virgen del Rocio
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Balearic Islands
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Palma, Balearic Islands, Spanje, 07120
- Werving
- Son Espases University Hospital
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Barcelona
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Badalona, Barcelona, Spanje, 08916
- Werving
- Institut Catala D'Oncologia - Badalona - Hospital Germans Trias i Pujol
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Sabadell, Barcelona, Spanje, 08208
- Werving
- Hospital Universitari Parc Tauli
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Terrassa, Barcelona, Spanje, 08221
- Werving
- Hospital Universitari Mutua Terrassa
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Cantabria
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Santander, Cantabria, Spanje, 39008
- Werving
- Hospital Universitario Marques de Valdecilla
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Galicia
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A Coruña, Galicia, Spanje, 15006
- Werving
- Complejo Hospitalario Universitario de a Coruna
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Madrid
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Pozuelo de Alarcón, Madrid, Spanje, 28223
- Werving
- Hospital Universitario Quironsalud Madrid
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Navarre
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Pamplona, Navarre, Spanje, 31008
- Werving
- Hospital Universitario de Navarra
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Principality of Asturias
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Oviedo, Principality of Asturias, Spanje, 33011
- Werving
- Hospital Universitario Central de Asturias
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Changhua, Taiwan, 50006
- Werving
- Changhua Christian Hospital
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Kaohsiung City, Taiwan, 80756
- Werving
- Kaohsiung Medical University Hospital
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New Taipei City, Taiwan, 23561
- Werving
- Taipei Medical University - Shuang Ho Hospital
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Taipei, Taiwan, 11490
- Werving
- Tri-Service General Hospital
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Taipei, Taiwan, 00116
- Werving
- Wanfang Hospital
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Taipei, Taiwan, 106
- Werving
- National Taiwan University Hospital
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Chiayi County
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Buzi, Chiayi County, Taiwan, 613
- Werving
- Chang Gung Medical Foundation Chia Yi Branch
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Hunan Province
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Taoyuan, Hunan Province, Taiwan, 33305
- Werving
- Chang Gung Memorial Hospital - Linkou Branch
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Kaohsiung
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Niaosong, Kaohsiung, Taiwan, 83301
- Werving
- Chang Gung Medical Foundation Kaohsiung Branch
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Bangkok, Thailand, 10700
- Werving
- Sriraj Hospital
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Chiang Mai, Thailand, 50200
- Werving
- Chaing Mai University
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Khon Kaen, Thailand, 40002
- Werving
- Faculty of Medicine
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Krung Thep Maha Nakhon [Bangko]
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Bangkok, Krung Thep Maha Nakhon [Bangko], Thailand, 10330
- Werving
- Chulalongkorn University
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Prague, Tsjechië, 10034
- Werving
- University Hospital Kralovske Vinohrady
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Prague, Tsjechië, 12808
- Werving
- Vseobecna Fakultni Nemocnice V Praze
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East Bohemia
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Hradec Králové, East Bohemia, Tsjechië, 50005
- Werving
- University Hospital Hradec Kralove
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South Moravian
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Brno, South Moravian, Tsjechië, 62500
- Werving
- University Hospital Brno
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-
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Istanbul, Turkije (Türkiye), 34418
- Werving
- Istanbul University Istanbul Faculty of Medicine
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Izmir, Turkije (Türkiye), 35340
- Werving
- Dokuz Eylul University
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Izmir, Turkije (Türkiye), 35100
- Werving
- Ege University
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Sakarya, Turkije (Türkiye), 54290
- Werving
- Sakarya University Medical Faculty
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Samsun, Turkije (Türkiye), 55239
- Werving
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
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Ankara
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Yenimahalle, Ankara, Turkije (Türkiye), 06200
- Werving
- Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
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Mersin
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Mezitli, Mersin, Turkije (Türkiye), 33200
- Werving
- VM Medical Park Mersin Hospital
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Suleymanpasa
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Tekirdağ, Suleymanpasa, Turkije (Türkiye), 59100
- Werving
- Tekirdag Namik Kemal University Hospital
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Yenimahalle
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Ankara, Yenimahalle, Turkije (Türkiye), 6500
- Werving
- Gazi University Faculty of Medicine
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Aberdeen, Verenigd Koninkrijk, AB25 2ZN
- Werving
- NHS Grampian: Aberdeen Royal Infirmary
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Uxbridge, Verenigd Koninkrijk, UB8 3NN
- Werving
- The Hillingdon Hospitals NHS Foundation Trust
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Arizona
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Scottsdale, Arizona, Verenigde Staten, 85259
- Werving
- Mayo Clinic - Arizona
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California
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Los Angeles, California, Verenigde Staten, 90095
- Werving
- David Geffen School of Medicine at UCLA
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Orange, California, Verenigde Staten, 92868
- Werving
- University of California Irvine Medical Center
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Sacramento, California, Verenigde Staten, 95817
- Ingetrokken
- UC Davis Comprehensive Cancer Center
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Florida
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Jacksonville, Florida, Verenigde Staten, 32224
- Werving
- Mayo Clinic Jacksonville
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46202
- Werving
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center
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Indianapolis, Indiana, Verenigde Staten, 46260
- Werving
- St Vincent Ascension at Peyton Manning Childrens Hospital
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Noblesville, Indiana, Verenigde Staten, 46062
- Werving
- Investigative Clinical Research of Indiana
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40536
- Werving
- University of Kentucky
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21201
- Werving
- University of Maryland Greenebaum Comprehensive Cancer Center
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02215
- Werving
- Beth Israel Deaconess Medical Center
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Michigan
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Detroit, Michigan, Verenigde Staten, 48202
- Werving
- Henry Ford Health System
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Grand Rapids, Michigan, Verenigde Staten, 49503
- Werving
- Cancer and Hematology Centers of Western Michigan
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55901
- Werving
- Mayo Clinic - Rochester
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New Jersey
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New Brunswick, New Jersey, Verenigde Staten, 08901
- Werving
- Rutgers Cancer Institute of New Jersey
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New York
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Stony Brook, New York, Verenigde Staten, 11794
- Werving
- Stony Brook University Hospital
-
Westbury, New York, Verenigde Staten, 11590
- Ingetrokken
- Clinical Research Alliance Inc
-
-
North Carolina
-
Durham, North Carolina, Verenigde Staten, 27710
- Werving
- Duke University Medical Center
-
Greenville, North Carolina, Verenigde Staten, 27834
- Werving
- East Carolina University
-
-
Ohio
-
Cleveland, Ohio, Verenigde Staten, 44106
- Werving
- University Hospitals Cleveland Medical Center
-
-
Texas
-
Houston, Texas, Verenigde Staten, 77030
- Ingetrokken
- Center for Oncology and Blood Disorders
-
-
Utah
-
Ogden, Utah, Verenigde Staten, 84405
- Werving
- Community Cancer Trials of Utah
-
-
Wisconsin
-
Waukesha, Wisconsin, Verenigde Staten, 53188
- Ingetrokken
- Prohealth Care Inc
-
-
-
-
-
Busan, Zuid -Korea, 49241
- Werving
- Pusan National University Hospital
-
Busan, Zuid -Korea, 47392
- Werving
- Inje University Busan Paik Hospital
-
Busan, Zuid -Korea, 49201
- Werving
- Dong-A University Hospital
-
Daegu, Zuid -Korea, 42601
- Werving
- Keimyung University Dongsan Hospital
-
Daegu, Zuid -Korea, 42415
- Werving
- Yeyungnam University Medical Center
-
Seoul, Zuid -Korea, 05505
- Werving
- Asan Medical Center
-
Seoul, Zuid -Korea, 06351
- Werving
- Samsung Medical Center
-
Seoul, Zuid -Korea, 07345
- Werving
- Yeouido St. Marys Hospital
-
Seoul, Zuid -Korea, 137-701
- Werving
- Seoul St Marys Hospital
-
-
Gyeonggi-do
-
Suwon, Gyeonggi-do, Zuid -Korea, 16247
- Werving
- St. Vincent Hospital - The Catholic University of Korea
-
-
Namdong-Gu
-
Incheon, Namdong-Gu, Zuid -Korea, 21565
- Werving
- Gachon University Gil Medical Center
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
Andere namen:
Cyclophosphamide will be administered IV as part of chemotherapy
Andere namen:
Doxorubicin will be administered IV as part of chemotherapy
Andere namen:
Vincristine will be administered IV as part of chemotherapy
Andere namen:
Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy
Andere namen:
|
|
Actieve vergelijker: 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
Andere namen:
Doxorubicin will be administered IV as part of chemotherapy
Andere namen:
Vincristine will be administered IV as part of chemotherapy
Andere namen:
Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy
Andere namen:
Rituximab will be administered IV, or subcutaneously (SC)
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence of Dose Limiting Toxicities (DLTs)
Tijdsspanne: Up to 35 days
|
Part 1A |
Up to 35 days
|
|
Incidence of Treatment Emergent Adverse Events (TEAEs)
Tijdsspanne: Up to 2 years
|
Part 1 |
Up to 2 years
|
|
Severity of TEAEs
Tijdsspanne: Up to 2 years
|
Part 1 |
Up to 2 years
|
|
Progression Free Survival (PFS), assessed by Independent Central Review (ICR)
Tijdsspanne: Up to 5 years
|
Part 2 |
Up to 5 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall Survival (OS)
Tijdsspanne: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Incidence of TEAEs
Tijdsspanne: Up to 2 years
|
Part 2 |
Up to 2 years
|
|
Severity of TEAEs
Tijdsspanne: Up to 2 years
|
Part 2 |
Up to 2 years
|
|
Event-Free Survival (EFS) assessed by ICR
Tijdsspanne: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Complete Response (CR) assessed by ICR
Tijdsspanne: Up to 22 weeks
|
Part 2 |
Up to 22 weeks
|
|
Best Overall Response (BOR) as assessed by local investigators
Tijdsspanne: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
CR as assessed by local investigators
Tijdsspanne: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
Duration of Response (DOR) as assessed by local investigators
Tijdsspanne: Up to 5 years
|
Part 1 and Part 2 |
Up to 5 years
|
|
Odronextamab concentrations in serum when administered with CHOP
Tijdsspanne: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
Occurrence of Anti-Drug Antibodies (ADA) to odronextamab
Tijdsspanne: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
Magnitude of ADA to odronextamab
Tijdsspanne: Up to 22 weeks
|
Part 1 and Part 2 |
Up to 22 weeks
|
|
PFS assessed by local investigator review
Tijdsspanne: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
EFS assessed by local investigator review
Tijdsspanne: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
BOR assessed by ICR
Tijdsspanne: Up to 22 weeks
|
Part 2 |
Up to 22 weeks
|
|
DOR assessed by ICR
Tijdsspanne: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Minimal Residual Disease (MRD) status
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Clinical Trial Management, Regeneron Pharmaceuticals
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
13 december 2023
Primaire voltooiing (Geschat)
30 maart 2028
Studie voltooiing (Geschat)
12 september 2029
Studieregistratiedata
Eerst ingediend
13 oktober 2023
Eerst ingediend dat voldeed aan de QC-criteria
13 oktober 2023
Eerst geplaatst (Werkelijk)
19 oktober 2023
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 november 2026
Laatste update ingediend die voldeed aan QC-criteria
3 november 2026
Laatst geverifieerd
1 november 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Neoplasmata
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Lymfatische ziekten
- Lymfoproliferatieve aandoeningen
- Immunoproliferatieve aandoeningen
- Lymfoom, non-Hodgkin
- Lymfoom, B-cel
- Lymfoom
- Hemische en lymfatische ziekten
- Lymfoom, grote B-cel, diffuus
- Aminozuren, peptiden en eiwitten
- Eiwitten
- Organische chemicaliën
- Heterocyclische verbindingen
- Heterocyclische verbindingen, 2-ring
- Heterocyclische verbindingen, gefuseerd ring
- Koolwaterstoffen
- Koolwaterstoffen, cyclisch
- Koolhydraten
- Alkaloïden
- Polycyclische aromatische koolwaterstoffen
- Koolwaterstoffen, aromatisch
- Polycyclische verbindingen
- Glycosiden
- Indolen
- Antilichamen, monoklonaal
- Antilichamen
- Immunoglobulinen
- Immunoproteïnen
- Bloedeiwitten
- Serum -globulines
- Globulines
- Zwangerschap
- Zwangere
- Steroïden
- Verbindingen met gefuseerde ring
- Fosforamide mosterd
- Stikstofmosterdverbindingen
- Mosterdverbindingen
- Koolwaterstoffen, gehalogeneerd
- Fosforamides
- Organofosforverbindingen
- Zwangerschap
- Zwangerschap
- Vinca -alkaloïden
- Secologanin tryptamine alkaloïden
- Indol alkaloïden
- Indolizidines
- Indolizines
- Antracyclines
- Naftacenes
- Aminoglycosides
- Antilichamen, monoklonaal, van murine afgeleid
- Daunorubicine
- Rituximab
- Prednison
- Prednisolon
- Cyclofosfamide
- Doxorubicine
- Vincristine
Andere studie-ID-nummers
- R1979-ONC-2105
- 2022-502785-25-00 (Ctis)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD-tijdsbestek voor delen
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
IPD-toegangscriteria voor delen
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- ANALYTIC_CODE
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .