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
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjenci z chłoniakiem B-komórkowym dużych komórek, którzy nigdy wcześniej nie byli leczeni, lub pacjenci u których choroba powróciła lub nie odpowiada na leczenie
- •Widoczne zmiany chorobowe (powiększone węzły chłonne lub guzy poza węzłami)
- •Ogólny stan zdrowia pozwalający na leczenie (skala ECOG ≤2)
- •Oczekiwana długość życia co najmniej 12 miesięcy
- •Prawidłowe funkcje krwi i narządów wewnętrznych
✗ Disqualifies
- •Chłoniak w mózgu lub zapalenie mózgu/opon mózgowych
- •Inna aktywna choroba nowotworowa lub poważne schorzenia przewlekłe
- •Poważne problemy z nerwami obwodowymi (trzecia stopnia lub wyższa)
- •Poprzednie leczenie przeciwnowotworowe (z wyjątkami dla niektórych pacjentów)
- •Nieaktywne lub słabo kontrolowane zakaźne choroby (HIV, żółtaczka typu B lub C, COVID-19)
- •Alergia na składniki badanego leku
- •Duża operacja chirurgiczna, przeszczep narządu lub radioterapia w ciągu ostatnich miesięcy
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 22, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (168)
Mayo Clinic - Arizona
Scottsdale, United States
David Geffen School of Medicine at UCLA
Los Angeles, United States
University of California Irvine Medical Center
Orange, United States
University of California (UC) Davis
Sacramento, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, United States
St Vincent Ascension at Peyton Manning Childrens Hospital
Indianapolis, United States
Investigative Clinical Research of Indiana
Noblesville, United States
University of Kentucky
Lexington, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, United States
Beth Israel Deaconess Medical Center
Boston, United States
Henry Ford Health System
Detroit, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, United States
Stony Brook University Hospital
Stony Brook, United States
Clinical Research Alliance Inc
Westbury, United States
Duke University Medical Center
Durham, United States
East Carolina University
Greenville, United States
University Hospitals Cleveland Medical Center
Cleveland, United States
Center for Oncology and Blood Disorders
Houston, United States
Community Cancer Trials of Utah
Ogden, United States
Prohealth Care Inc
Waukesha, United States
Liverpool Hospital
Liverpool, Australia
Calvary Mater Newcastle
Waratah, Australia
Icon Cancer Centre - Wesley
Auchenflower, Australia
Pindara Private Hospital
Benowa, Australia
Epworth Freemasons
East Melbourne, Australia
Landeskrankenhaus Hochsteiermark
Leoben, Austria
Kepler University Hospital
Linz, Austria
Medical University Graz
Graz, Austria
Medical University of Vienna
Vienna, Austria
Hanusch Krankenhaus
Vienna, Austria
Klinikum Wels-Grieskirchen
Wels, Austria
AZ St.-Elisabeth Herentals vzw
Herentals, Belgium
Centre Hospitalier Regional de Verviers
Verviers, Belgium
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent, Belgium
Az Delta
Roeselare, Belgium
Institut Jules Bordet
Brussels, Belgium
Hospital Clinico Universidad de Los Andes
Santiago, Chile
Centro Oncologia de Precision Universidad Mayor
Santiago, Chile
Inmunocel
Santiago, Chile
Clinica Alemana de Santiago
Santiago, Chile
University Hospital Hradec Kralove
Hradec Králové, Czechia
University Hospital Brno
Brno, Czechia
University Hospital Kralovske Vinohrady
Prague, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia
Centre Hospitalier de Cornouaille Quimper Concarneau
Quimper, France
Centre Hospitalier Universitaire (CHU) Rennes
Rennes, France
CHRU de Tours
Tours, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
Centre Hospitalier Universitaire (CHU) de Bordeaux
Pessac, France
Centre Hospitalier Universitaire De Poitiers
Poitiers, France
Hopital Saint Vincent-de-Paul
Lille, France
Nantes University Hospital
Nantes, France
Centre Hospitalier Metropole Savoie
Chambéry, France
Centre Hospitalier Universitaire Angers
Angers, France
Centre Leon Berard
Lyon, France
Assistance Publique Hopitaux Universitaires de Marseille (AP-HM) Conception
Marseille, France
Change Annecy
Metz-Tessy, France
CHU Nimes Institut de Cancerologie
Nîmes, France
Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, France
CHU de Saint-Etienne
Saint-Etienne, France
Hopital Victor Dupouy Argenteuil
Argenteuil, France
Avicenne Hospital
Bobigny, France
Gustave Roussy
Villejuif, France
Robert-Bosch-Krankenhaus
Stuttgart, Germany
Kliniken Ostalb Stauferklinikum Schwab Gmund
Mutlangen, Germany
Clinic Frankfurt (Oder)
Frankfurt am Main, Germany
University Hospital Essen
Essen, Germany
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, Germany
UKS Homburg
Homburg, Germany
Hematological Praxis Dresden
Dresden, Germany
Vivantes Klinikum Am Urban
Berlin, Germany
University Hospital Carl Gustav Carus
Dresden, Germany
Stadtisches Krankenhaus Kiel
Kiel, Germany
Beaumont Hospital
Dublin, Ireland
St James Hospital and Trinity College Dublin
Dublin, Ireland
The Chaim Sheba Medical Center
Tel Litwinsky, Israel
Samson Assuta Ashdod University Hospital
Ashdod, Israel
Bnai Zion Medical Center
Haifa, Israel
Hadassah Medical Center
Jerusalem, Israel
Galilee Medical Center
Nahariya, Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Italy
ASST Monza Ospedale San Gerardo
Monza, Italy
Azienda Ospedaliera Ordine Mauriziano Torino, Presidio Umberto I of Turin
Turin, Italy
Istituto Europeo di Oncologia
Milan, Italy
A.O.U. di Modena
Modena, Italy
Federico II University
Naples, Italy
AOU Maggiore della Carita
Novara, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Azienda Ospedaliera di Perugia
Perugia, Italy
Ospedale Santa Maria delle Croci
Ravenna, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Italy
Hematology - Città della Salute e della Scienza di Torino
Turin, Italy
Santa Maria della Misericordia
Udine, Italy
Ospedale di Circolo e Fondazione Macchi Varese
Varese, Italy
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Hospital Tg Ampuan Afzan
Kuantan, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, Malaysia
Hospital Ampang
Ampang, Malaysia
Subang Jaya Medical Center
Subang Jaya, Malaysia
Matopolskie Centrum Medyczne S.C.
Krakow, Poland
Uniwersytecki Szpital Kliniczny
Wroclaw, Poland
Pratia Poznan Medical Center
Poznan, Poland
Aidport
Skorzewo, Poland
Szpital Uniwersytecki Nr2 Bydgoszcz
Bydgoszcz, Poland
Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center
Gdansk, Poland
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, Poland
Narodowy Instytut Onkologii
Warsaw, Poland
Szpital Szpecjalistyczny w Walbrzychu
Wałbrzych, Poland
Wielospecjalistyczne Centrum Onkologii i Traumatologii
Lodz, Poland
National University Hospital Singapore
Singapore, Singapore
National Cancer Centre of Singapore
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
Keimyung University Dongsan Hospital
Dalseo-gu, South Korea
St. Vincent Hospital - The Catholic University of Korea
Suwon, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
Dong-A University Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
Yeyungnam University Medical Center
Daegu, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Yeouido St. Marys Hospital
Seoul, South Korea
Seoul St Marys Hospital
Seoul, South Korea
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Son Espases University Hospital
Palma, Spain
Institut Catala D'Oncologia - Badalona - Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Universitari Parc Tauli
Sabadell, Spain
Hospital Universitari Mutua Terrassa
Terrassa, Spain
Hospital Universitario Marques de Valdecilla
Santander, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Spain
Hospital Universitario de Navarra
Pamplona, Spain
Hospital Universitario Central de Asturias
Oviedo, Spain
Hospital Sant Pau
Barcelona, Spain
Institut Catala d'Oncologia
Barcelona, Spain
Hospital Virgen De Las Nieves De Granada
Granada, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Fundacion Jimenez Diaz University Hospital
Madrid, Spain
Hospital Universitario HM Sanchinarro
Madrid, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital General Universitario de Toledo
Toledo, Spain
Instituto Valenciano de Oncologia
Valencia, Spain
University Hospital Doctor Peset
Valencia, Spain
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, Spain
Chang Gung Medical Foundation Chia Yi Branch
Buzi, Taiwan
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan, Taiwan
Changhua Christian Hospital
Changhua, Taiwan
Taipei Medical University - Shuang Ho Hospital
New Taipei City, Taiwan
Wanfang Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chulalongkorn University
Bangkok, Thailand
Sriraj Hospital
Bangkok, Thailand
Chaing Mai University
Chiang Mai, Thailand
Faculty of Medicine
Khon Kaen, Thailand
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Yenimahalle, Turkey (Türkiye)
VM Medical Park Mersin Hospital
Mezitli, Turkey (Türkiye)
Tekirdag Namik Kemal University Hospital
Tekirdağ, Turkey (Türkiye)
Gazi Universitesi
Beşevler, Turkey (Türkiye)
Istanbul University Istanbul Faculty of Medicine
Istanbul, Turkey (Türkiye)
Ege University
Izmir, Turkey (Türkiye)
Dokuz Eylul University
Izmir, Turkey (Türkiye)
Sakarya University Medical Faculty
Sakarya, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, Turkey (Türkiye)
NHS Grampian: Aberdeen Royal Infirmary
Aberdeen, United Kingdom
The Hillingdon Hospitals NHS Foundation Trust
Uxbridge, United Kingdom
Trial contact
Clinical Trials Administrator
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/9/2026.
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