RecruitingPhase III🇵🇱 PolandEN original

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

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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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