A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Patients With Previously Untreated Diffuse Large B-cell Lymphoma
NCT ID: NCT06091865
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
904 participants
INTERVENTIONAL
2023-12-13
2029-04-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Odronextamab will be administered by intravenous (IV) infusion
Cyclophosphamide
Cyclophosphamide will be administered IV as part of chemotherapy
Doxorubicin
Doxorubicin will be administered IV as part of chemotherapy
Vincristine
Vincristine will be administered IV as part of chemotherapy
Prednisone/Prednisolone
Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy
Rituximab + CHOP
Part 2 is the randomized controlled portion, participants will receive either Odro-CHOP or R-CHOP.
Rituximab
Rituximab will be administered IV, or subcutaneously (SC)
Cyclophosphamide
Cyclophosphamide will be administered IV as part of chemotherapy
Doxorubicin
Doxorubicin will be administered IV as part of chemotherapy
Vincristine
Vincristine will be administered IV as part of chemotherapy
Prednisone/Prednisolone
Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy
Interventions
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Odronextamab
Odronextamab will be administered by intravenous (IV) infusion
Rituximab
Rituximab will be administered IV, or subcutaneously (SC)
Cyclophosphamide
Cyclophosphamide will be administered IV as part of chemotherapy
Doxorubicin
Doxorubicin will be administered IV as part of chemotherapy
Vincristine
Vincristine will be administered IV as part of chemotherapy
Prednisone/Prednisolone
Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2
4. Life expectancy ≥ 12 months
5. International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only;
6. Adequate hematologic and organ function, as defined in the protocol.
Exclusion Criteria
2. Another active malignancy, significant active disease or medical condition, as described in the protocol
3. Peripheral neuropathy Grade ≥3
4. Treatment with any systemic anti-lymphoma therapy, except for participants with relapsed/refractory (R/R) DLBCL and participants with DLBCL transformed from an indolent follicular lymphoma after treatment with systemic anti-lymphoma therapy.
5. 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
6. Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol
7. Allergy/hypersensitivity to study drugs, as described in the protocol
8. 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.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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David Geffen School of Medicine at UCLA
Los Angeles, California, United States
University of California Irvine Medical Center
Orange, California, United States
University of California (UC) Davis
Sacramento, California, United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
St Vincent Ascension at Peyton Manning Childrens Hospital
Indianapolis, Indiana, United States
Investigative Clinical Research of Indiana
Noblesville, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Clinical Research Alliance Inc
Westbury, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Center for Oncology and Blood Disorders
Houston, Texas, United States
Community Cancer Trials of Utah
Ogden, Utah, United States
Prohealth Care Inc
Waukesha, Wisconsin, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Icon Cancer Centre - Wesley
Auchenflower, Queensland, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Epworth Freemasons
East Melbourne, Victoria, Australia
Landeskrankenhaus Hochsteiermark
Leoben, Styria, Austria
Kepler University Hospital
Linz, Upper Austria, 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, Antwerp, Belgium
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent, Oost-Vlaanderen, Belgium
Az Delta
Roeselare, West Vlaanderen, Belgium
Institut Jules Bordet
Brussels, , Belgium
Centre Hospitalier Regional de Verviers
Verviers, , Belgium
Hospital Clinico Universidad de Los Andes
Santiago, Las Condes, Chile
Inmunocel
Santiago, Santiago Metropolitan, Chile
Clinica Alemana de Santiago
Santiago, , Chile
University Hospital Hradec Kralove
Hradec Králové, East Bohemia, Czechia
University Hospital Kralovske Vinohrady
Prague, , Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, , Czechia
Centre Hospitalier Universitaire (CHU) Rennes
Rennes, Brittany Region, France
CHRU de Tours
Tours, Centre-Val de Loire, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, Gironde, France
Hopital Saint Vincent-de-Paul
Lille, Nord, France
Centre Hospitalier Universitaire (CHU) de Bordeaux
Pessac, Nouvelle-Aquitaine, France
CHU de Poitiers
Poitiers, Nouvelle-Aquitaine, France
Nantes University Hospital
Nantes, Pays de la Loire Region, France
Centre Hospitalier Metropole Savoie
Chambéry, Savoie, France
Gustave Roussy
Villejuif, Val de Marne / Ile de France, France
Centre Hospitalier Universitaire Angers
Angers, , 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, Île-de-France Region, France
Avicenne Hospital
Bobigny, Île-de-France Region, France
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany
Kliniken Ostalb Stauferklinikum Schwab Gmund
Mutlangen, Gmund, Germany
Clinic Frankfurt (Oder)
Frankfurt am Main, Hesse, Germany
University Hospital Essen
Essen, North Rhine-Westphalia, Germany
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, Rhineland-Palatinate, Germany
Hematological Praxis Dresden
Dresden, Saxony, Germany
University Hospital Carl Gustav Carus
Dresden, , Germany
Stadtisches Krankenhaus Kiel
Kiel, , Germany
Beaumont Hospital
Dublin, Leinster, Ireland
St James Hospital and Trinity College Dublin
Dublin, , Ireland
The Chaim Sheba Medical Center
Tel Litwinsky, Tel Aviv, 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 (fc), Forli Cesena, Italy
ASST Monza Ospedale San Gerardo
Monza, Lombardy, Italy
Istituto Europeo di Oncologia
Milan, , Italy
A.O.U. di Modena
Modena, , Italy
Federico II University
Napoli, , 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
Hematology - Città della Salute e della Scienza di Torino
Turin, , Italy
Santa Maria della Misericordia
Udine, , Italy
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Ampang
Ampang, Pahang, Malaysia
Hospital Tg Ampuan Afzan
Kuantan, Pahang, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, Malaysia
Subang Jaya Medical Center
Subang Jaya, Selangor, Malaysia
Matopolskie Centrum Medyczne S.C.
Krakow, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny
Wroclaw, Lower Silesian Voivodeship, Poland
Pratia Poznan Medical Center
Poznan, Wielkopolska, 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
Szpital Szpecjalistyczny w Walbrzychu
Wałbrzych, , Poland
National University Hospital Singapore
Singapore, , Singapore
National Cancer Centre of Singapore
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
St. Vincent Hospital - The Catholic University of Korea
Suwon, Gyeonggi-do, South Korea
Gachon University Gil Medical Center
Incheon, Namdong-Gu, 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
Keimyung University Dongsan Hospital
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, A Coruna, Spain
Son Espases University Hospital
Palma, Balearic Islands, Spain
Hospital Universitari Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Central De Asturias
Oviedo, Principality of Asturias, Spain
Hospital Sant Pau
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, Servicio de Hematologia
Madrid, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital General Universitario de Toledo
Toledo, , Spain
Instituto Valenciano de Oncologia
Valencia, , Spain
University Hospital Doctor Peset
Valencia, , Spain
Chang Gung Medical Foundation Chia Yi Branch
Buzi, , 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
Chang Gung Memorial Hospital- Linkou Branch
Taoyuan District, , Taiwan
Chulalongkorn University
Bangkok, Krung Thep Maha Nakhon [Bangko], 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, Ankara, Turkey (Türkiye)
VM Medical Park Mersin Hospital
Mezitli, Mersin, Turkey (Türkiye)
Tekirdag Namik Kemal University Hospital
Tekirdağ, Suleymanpasa, 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 Universty 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
Countries
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Other Identifiers
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2022-502785-25-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
R1979-ONC-2105
Identifier Type: -
Identifier Source: org_study_id
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