A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma
Start Date
12/13/2023
Completion Date
9/12/2029
Summary
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
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Odronextamab
Rituximab
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone/Prednisolone
Conditions
Locations
Mayo Clinic - Arizona
Scottsdale, Arizona 85259
United States
David Geffen School of Medicine at UCLA
Los Angeles, California 90095
United States
University of California Irvine Medical Center
Orange, California 92868
United States
University of California (UC) Davis
Sacramento, California 95817
United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana 46202
United States
St Vincent Ascension at Peyton Manning Childrens Hospital
Indianapolis, Indiana 46260
United States
Investigative Clinical Research of Indiana
Noblesville, Indiana 46062
United States
University of Kentucky
Lexington, Kentucky 40536
United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland 21201
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Henry Ford Health System
Detroit, Michigan 48202
United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan 49503
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United States
Stony Brook University Hospital
Stony Brook, New York 11794
United States
Clinical Research Alliance Inc
Westbury, New York 11590
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
East Carolina University
Greenville, North Carolina 27834
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Center for Oncology and Blood Disorders
Houston, Texas 77030
United States
Community Cancer Trials of Utah
Ogden, Utah 84405
United States
Prohealth Care Inc
Waukesha, Wisconsin 53188
United States
Liverpool Hospital
Liverpool, New South Wales 2170
Australia
Calvary Mater Newcastle
Waratah, New South Wales 2298
Australia
Icon Cancer Centre - Wesley
Auchenflower, Queensland 4066
Australia
Pindara Private Hospital
Benowa, Queensland 4217
Australia
Epworth Freemasons
East Melbourne, Victoria 3121
Australia
Landeskrankenhaus Hochsteiermark
Leoben, Styria 8700
Austria
Kepler University Hospital
Linz, Upper Austria 4020
Austria
Medical University Graz
Graz, 8036
Austria
Medical University of Vienna
Vienna, 1090
Austria
Hanusch Krankenhaus
Vienna, 1140
Austria
Klinikum Wels-Grieskirchen
Wels, 4600
Austria
AZ St.-Elisabeth Herentals vzw
Herentals, Antwerp 2200
Belgium
Centre Hospitalier Regional de Verviers
Verviers, Liege 4800
Belgium
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent, Oost-Vlaanderen 9000
Belgium
Az Delta
Roeselare, West-Vlaanderen 8800
Belgium
Institut Jules Bordet
Brussels, 1000
Belgium
Hospital Clinico Universidad de Los Andes
Santiago, Las Condes 7620157
Chile
Centro Oncologia de Precision Universidad Mayor
Santiago, Santiago Metropolitan 7560907
Chile
Inmunocel
Santiago, Santiago Metropolitan 7580206
Chile
Clinica Alemana de Santiago
Santiago, 7650568
Chile
University Hospital Hradec Kralove
Hradec Králové, East Bohemia 50005
Czechia
University Hospital Brno
Brno, South Moravian 62500
Czechia
University Hospital Kralovske Vinohrady
Prague, 10034
Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, 12808
Czechia
Centre Hospitalier de Cornouaille Quimper Concarneau
Quimper, Brittany Region 29107
France
Centre Hospitalier Universitaire (CHU) Rennes
Rennes, Brittany Region 35033
France
CHRU de Tours
Tours, Centre-Val de Loire 37044
France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, Gironde 33077
France
Centre Hospitalier Universitaire (CHU) de Bordeaux
Pessac, New Aquitaine 33600
France
Centre Hospitalier Universitaire De Poitiers
Poitiers, New Aquitaine 86000
France
Hopital Saint Vincent-de-Paul
Lille, Nord 5900
France
Nantes University Hospital
Nantes, Pays de la Loire Region 44093
France
Centre Hospitalier Metropole Savoie
Chambéry, Savoie 73000
France
Centre Hospitalier Universitaire Angers
Angers, 49000
France
Centre Leon Berard
Lyon, 69008
France
Assistance Publique Hopitaux Universitaires de Marseille (AP-HM) Conception
Marseille, 130005
France
Change Annecy
Metz-Tessy, 74374
France
CHU Nimes Institut de Cancerologie
Nîmes, 30029
France
Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, 75571
France
CHU de Saint-Etienne
Saint-Etienne, 42055
France
Hopital Victor Dupouy Argenteuil
Argenteuil, Île-de-France Region 95100
France
Avicenne Hospital
Bobigny, Île-de-France Region 93000
France
Gustave Roussy
Villejuif, Île-de-France Region 94800
France
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg 70376
Germany
Kliniken Ostalb Stauferklinikum Schwab Gmund
Mutlangen, Gmund D-73557
Germany
Clinic Frankfurt (Oder)
Frankfurt am Main, Hesse 15236
Germany
University Hospital Essen
Essen, North Rhine-Westphalia 45122
Germany
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, Rhineland-Palatinate 55131
Germany
UKS Homburg
Homburg, Saarland 66421
Germany
Hematological Praxis Dresden
Dresden, Saxony 01307
Germany
Vivantes Klinikum Am Urban
Berlin, 10967
Germany
University Hospital Carl Gustav Carus
Dresden, 01307
Germany
Stadtisches Krankenhaus Kiel
Kiel, 24116
Germany
Beaumont Hospital
Dublin, Leinster D09V2N0
Ireland
St James Hospital and Trinity College Dublin
Dublin, D08
Ireland
The Chaim Sheba Medical Center
Tel Litwinsky, Tel Aviv 5265601
Israel
Samson Assuta Ashdod University Hospital
Ashdod, 7747629
Israel
Bnai Zion Medical Center
Haifa, 31048
Israel
Hadassah Medical Center
Jerusalem, 91200
Israel
Galilee Medical Center
Nahariya, 2210001
Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Forli-Cesena 47014
Italy
ASST Monza Ospedale San Gerardo
Monza, Monza E Brianza 20900
Italy
Azienda Ospedaliera Ordine Mauriziano Torino, Presidio Umberto I of Turin
Turin, Piedmont 10137
Italy
Istituto Europeo di Oncologia
Milan, 20141
Italy
A.O.U. di Modena
Modena, 41124
Italy
Federico II University
Naples, 80131
Italy
AOU Maggiore della Carita
Novara, 28100
Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Italy
Azienda Ospedaliera di Perugia
Perugia, 06132
Italy
Ospedale Santa Maria delle Croci
Ravenna, 48121
Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, 00128
Italy
Hematology - Città della Salute e della Scienza di Torino
Turin, 10126
Italy
Santa Maria della Misericordia
Udine, 33100
Italy
Ospedale di Circolo e Fondazione Macchi Varese
Varese, 21100
Italy
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur 59100
Malaysia
Hospital Tg Ampuan Afzan
Kuantan, Pahang 25200
Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, Sabah 88200
Malaysia
Hospital Ampang
Ampang, Selangor 68000
Malaysia
Subang Jaya Medical Center
Subang Jaya, Selangor 47500
Malaysia
Matopolskie Centrum Medyczne S.C.
Krakow, Lesser Poland Voivodeship 30-510
Poland
Uniwersytecki Szpital Kliniczny
Wroclaw, Lower Silesian Voivodeship 50-367
Poland
Pratia Poznan Medical Center
Poznan, Wielkopolska 60185
Poland
Aidport
Skorzewo, Wielkopolska 60185
Poland
Szpital Uniwersytecki Nr2 Bydgoszcz
Bydgoszcz, 85-168
Poland
Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center
Gdansk, 80-952
Poland
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-954
Poland
Narodowy Instytut Onkologii
Warsaw, 02-781
Poland
Szpital Szpecjalistyczny w Walbrzychu
Wałbrzych, 58-300
Poland
Wielospecjalistyczne Centrum Onkologii i Traumatologii
Lodz, Łódź Voivodeship 93-510
Poland
National University Hospital Singapore
Singapore, 119074
Singapore
National Cancer Centre of Singapore
Singapore, 168583
Singapore
Tan Tock Seng Hospital
Singapore, 308433
Singapore
Keimyung University Dongsan Hospital
Dalseo-gu, Daegu 42601
South Korea
St. Vincent Hospital - The Catholic University of Korea
Suwon, Gyeonggi-do 16247
South Korea
Gachon University Gil Medical Center
Incheon, Namdong-Gu 21565
South Korea
Inje University Busan Paik Hospital
Busan, 47392
South Korea
Dong-A University Hospital
Busan, 49201
South Korea
Pusan National University Hospital
Busan, 49241
South Korea
Yeyungnam University Medical Center
Daegu, 42415
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Yeouido St. Marys Hospital
Seoul, 07345
South Korea
Seoul St Marys Hospital
Seoul, 137-701
South Korea
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna 15706
Spain
Hospital Universitario Virgen del Rocio
Seville, Andalusia 41013
Spain
Son Espases University Hospital
Palma, Balearic Islands 07120
Spain
Institut Catala D'Oncologia - Badalona - Hospital Germans Trias i Pujol
Badalona, Barcelona 08916
Spain
Hospital Universitari Parc Tauli
Sabadell, Barcelona 08208
Spain
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona 08221
Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid 28223
Spain
Hospital Universitario de Navarra
Pamplona, Navarre 31008
Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias 33011
Spain
Hospital Sant Pau
Barcelona, 08041
Spain
Institut Catala d'Oncologia
Barcelona, 08908
Spain
Hospital Virgen De Las Nieves De Granada
Granada, 18014
Spain
Hospital Universitario Infanta Leonor
Madrid, 28031
Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034
Spain
Fundacion Jimenez Diaz University Hospital
Madrid, 28040
Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050
Spain
Hospital Universitario Virgen Macarena
Seville, 41009
Spain
Hospital General Universitario de Toledo
Toledo, 45007
Spain
Instituto Valenciano de Oncologia
Valencia, 46009
Spain
University Hospital Doctor Peset
Valencia, 46017
Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, 46026
Spain
Chang Gung Medical Foundation Chia Yi Branch
Buzi, Chiayi County 613
Taiwan
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan, Hunan Province 33305
Taiwan
Changhua Christian Hospital
Changhua, 50006
Taiwan
Taipei Medical University - Shuang Ho Hospital
New Taipei City, 23561
Taiwan
Wanfang Hospital
Taipei, 00116
Taiwan
National Taiwan University Hospital
Taipei, 10002
Taiwan
Chulalongkorn University
Bangkok, Krung Thep Maha Nakhon [Bangko] 10330
Thailand
Sriraj Hospital
Bangkok, 10700
Thailand
Chaing Mai University
Chiang Mai, 50200
Thailand
Faculty of Medicine
Khon Kaen, 40002
Thailand
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Yenimahalle, Ankara 06200
Turkey (Türkiye)
VM Medical Park Mersin Hospital
Mezitli, Mersin 33200
Turkey (Türkiye)
Tekirdag Namik Kemal University Hospital
Tekirdağ, Suleymanpasa 59100
Turkey (Türkiye)
Gazi Universitesi
Beşevler, 6500
Turkey (Türkiye)
Istanbul University Istanbul Faculty of Medicine
Istanbul, 34418
Turkey (Türkiye)
Ege University
Izmir, 35100
Turkey (Türkiye)
Dokuz Eylul University
Izmir, 35340
Turkey (Türkiye)
Sakarya University Medical Faculty
Sakarya, 54290
Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55239
Turkey (Türkiye)
NHS Grampian: Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
United Kingdom
The Hillingdon Hospitals NHS Foundation Trust
Uxbridge, UB8 3NN
United Kingdom