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A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma

NCT06091254 · Regeneron Pharmaceuticals
In plain English

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Official title
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)
About this study
This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL). This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone. The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for NHL). 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 * 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) * How the study drug affects quality of life and ability to complete routine daily activities.
Eligibility criteria
Key Inclusion Criteria: 1. Diagnosis of Cluster of Differentiation 20\^+ (CD20\^+) FL Grade 1-3a, stage II bulky or stage III / IV 2. Need for treatment as described in the protocol 3. Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 5. Adequate bone marrow function and hepatic function, as described in the protocol Key Exclusion Criteria: 1. Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma 2. Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma 3. Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma 4. Treatment with any systemic anti-lymphoma therapy 5. Infections and allergy/hypersensitivity to study drug or excipient, as described in the protocol NOTE: Other protocol defined inclusion/exclusion criteria apply
Study design
Enrollment target: 822 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-12-12
Estimated completion: 2029-11-03
Last updated: 2026-03-11
Interventions
Drug: OdronextamabDrug: RituximabDrug: CyclophosphamideDrug: DoxorubicinDrug: VincristineDrug: Prednisone/prednisoloneDrug: Bendamustine
Primary outcomes
  • Incidence of Dose-Limiting Toxicities (DLTs) for odronextamab (Up to 35 days)
  • Incidence of Treatment-Emergent Adverse Events (TEAEs) of odronextamab (Up to 2 years)
  • Severity of TEAEs of odronextamab (Up to 2 years)
Sponsor
Regeneron Pharmaceuticals · industry
Contacts & investigators
ContactClinical Trials Administrator · contact · clinicaltrials@regeneron.com · 844-734-6643
InvestigatorClinical Trial Management · study_director, Regeneron Pharmaceuticals
All locations (190)
University of Arizona Cancer CenterRecruiting
Tucson, Arizona, United States
David Geffen School of Medicine at UCLARecruiting
Los Angeles, California, United States
UC Irvine HealthWithdrawn
Orange, California, United States
Investigative Clinical Research of IndianaRecruiting
Noblesville, Indiana, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
Hattiesburg ClinicCompleted
Hattiesburg, Mississippi, United States
Icahn School of Medicine at Mt SinaiRecruiting
New York, New York, United States
Stony Brook University HospitalRecruiting
Stony Brook, New York, United States
Clinical Research Alliance IncWithdrawn
Westbury, New York, United States
University of North CarolinaRecruiting
Chapel Hill, North Carolina, United States
Levine Cancer InstituteRecruiting
Charlotte, North Carolina, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
Vanderbilt University Medical CenterRecruiting
Nashville, Tennessee, United States
Center for Oncology and Blood DisordersRecruiting
Houston, Texas, United States
HOPE Cancer Center of East TexasWithdrawn
Tyler, Texas, United States
Huntsman Cancer Institute - Oncology DivisionRecruiting
Salt Lake City, Utah, United States
University of VirginiaRecruiting
Charlottesville, Virginia, United States
Virginia Commonwealth UniversityWithdrawn
Richmond, Virginia, United States
Prohealth Care IncWithdrawn
Waukesha, Wisconsin, United States
Ingham InstituteRecruiting
Liverpool, New South Wales, Australia
Icon Cancer Centre - WesleyRecruiting
Auchenflower, Queensland, Australia
Flinders Medical CentreRecruiting
Bedford Park, South Australia, Australia
Monash HealthRecruiting
Clayton, Victoria, Australia
Epworth FreemasonsRecruiting
East Melbourne, Victoria, Australia
St Vincent's Hospital - MelbourneRecruiting
Fitzroy, Victoria, Australia
Alfred Hospital and Monash UniversityRecruiting
Melbourne, Victoria, Australia
Ordensklinikum LinzRecruiting
Linz, Osterreich, Austria
Ordensklinikum Linz Gmbh, ElisabethinenRecruiting
Linz, Austria
Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin IIIRecruiting
Salzburg, Austria
Medical University of ViennaRecruiting
Vienna, Austria
Hanusch KrankenhausRecruiting
Vienna, Austria
AZ St.-Elisabeth Herentals vzwRecruiting
Herentals, Antwerp, Belgium
Hopital De JolimontWithdrawn
La Louvière, Hainaut, Belgium
Universitair Ziekenhuis (UZ) Gent/ Ghent University HospitalWithdrawn
Ghent, Oost-Vlaanderen, Belgium
Ziekenhuis Netwerk Antwerpen StuivenbergWithdrawn
Antwerp, Belgium
Institut Jules BordetWithdrawn
Brussels, Belgium
Ensino e Terapia de Inovacao Clinica Amo (Etica)Recruiting
Salvador, Estado de Bahia, Brazil
Instituto Mario Pena de Ensino Pesquisa e InovacaoRecruiting
Belo Horizonte, Minas Gerais, Brazil
Liga Norte Riograndense Contra o CancerRecruiting
Natal, Rio Grande do Norte, Brazil
Instituto do Cancer em Hospital Sao Vicente de PauloRecruiting
Passo Fundo, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto AlegreRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Hematologia e OncologiaRecruiting
Joinville, Santa Catarina, Brazil
Animi Unidade de Tratamento Oncologico LtdaRecruiting
Lages, Santa Catarina, Brazil
Fundacao Pio XII Hospital de AmorRecruiting
Barretos, São Paulo, Brazil
Amaral Carvalho HospitalRecruiting
Jaú, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao PauloRecruiting
Ribeirão Preto, São Paulo, Brazil
Instituto DOr de Pesquisa e Ensino Df StarRecruiting
Brasília, Brazil
Instituto Nacional de Cancer Jose Alencar Gomes da SilvaRecruiting
Rio de Janeiro, Brazil
Instituto AmericasRecruiting
Rio de Janeiro, Brazil
Hospital Alemao Oswaldo CruzRecruiting
São Paulo, Brazil
AC Camargo Cancer CenterRecruiting
São Paulo, Brazil
Clinical Hospital of Medicine School at Sao Paulo UniversityRecruiting
São Paulo, Brazil
Casa de Saude Santa MarcelinaRecruiting
São Paulo, Brazil
Tom Baker Cancer CenterRecruiting
Calgary, Alberta, Canada
Saint John Regional HospitalRecruiting
Saint John, New Brunswick, Canada
Centre Integre de Sante et de Services Sociaux (CISSS) de la Monteregie-CentreRecruiting
Greenfield Park, Quebec, Canada
CHU de Quebec - Universite LavalRecruiting
Québec, Quebec, Canada
Ciusss de Lestrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)Recruiting
Sherbrooke, Quebec, Canada
Fundacion Arturo Lopez PerezRecruiting
Santiago, Santiago Metropolitan, Chile
Centro Oncologia de Precision Universidad MayorWithdrawn
Santiago, Santiago Metropolitan, Chile
InmunocelRecruiting
Santiago, Santiago Metropolitan, Chile
Clinica Alemana de SantiagoRecruiting
Santiago, Santiago Metropolitan, Chile
University Hospital Hradec KraloveRecruiting
Hradec Králové, Czechia
University Hospital Kralovske VinohradyRecruiting
Prague, Czechia
Vseobecna Fakultni NemocniceRecruiting
Prague, Czechia
Centre Hospitalier Universitaire (CHU) RennesRecruiting
Rennes, Brittany Region, France
Centre Hospitalier Regional Universitaire de ToursRecruiting
Tours, Centre-Val de Loire, France
Nantes University HospitalRecruiting
Nantes, Pays de la Loire Region, France
Hopital de la ConceptionRecruiting
Marseille, Provence-Alpes-Côte d'Azur Region, France
Centre Hospitalier Universitaire AngersRecruiting
Angers, France
Institut Paoli CalmettesRecruiting
Marseille, France
Hopital Saint LouisRecruiting
Paris, France
Hopital Saint-AntoineRecruiting
Paris, France
Centre Hospitalier Universitaire (CHU) de PoitiersRecruiting
Poitiers, France
Institut de Cancerologie Strasbourg Europe (ICANS)Recruiting
Strasbourg, France
Hopital Victor Dupouy ArgenteuilRecruiting
Argenteuil, Île-de-France Region, France
Gustave RoussyRecruiting
Villejuif, Île-de-France Region, France
Robert-Bosch-KrankenhausWithdrawn
Stuttgart, Baden-Wurttemberg, Germany
University Hospital WurzburgRecruiting
Würzburg, Bavaria, Germany
Kliniken Ostalb Stauferklinikum Schwab GmundRecruiting
Mutlangen, Gmund, Germany
Clinic Frankfurt (Oder)Recruiting
Frankfurt am Main, Hesse, Germany
Universitatsmedizin der Johannes-Gutenberg Universitat MainzRecruiting
Mainz, Rhineland-Palatinate, Germany
Hematological Praxis DresdenRecruiting
Dresden, Saxony, Germany
Charite Universitatsmedizin Berlin Campus Benjamin FranklinRecruiting
Berlin, Germany
University Hospital Carl Gustav CarusRecruiting
Dresden, Germany
Stadtisches Krankenhaus KielRecruiting
Kiel, Germany
Samson Assuta Ashdod University HospitalRecruiting
Ashdod, Israel
Bnai Zion Medical CenterRecruiting
Haifa, Israel
Hadassah Medical CenterRecruiting
Jerusalem, Israel
Galilee Medical CenterRecruiting
Nahariya, Israel
Rabin Medical CenterRecruiting
Petah Tikva, Israel
Chaim Sheba Medical CenterRecruiting
Ramat Gan, Israel
Tel Aviv Sourasky Medical CenterRecruiting
Tel Aviv, Israel
Istituto Romagnolo Per Lo Studio Dei TumoriRecruiting
Meldola, Forli Cesena, Italy
Irccs Aou Di Bologna- Policlinico Di Sant'Orsola MalpighiRecruiting
Bologna, Italia, Italy
Pia Fondazione PanicoRecruiting
Tricase, Lecce, Italy
IRCCS Ospedale Policlinico San MartinoRecruiting
Genoa, Liguria, Italy
Candiolo Cancer Institute, FPO, IRCCSRecruiting
Candiolo, Torino, Italy
UOC Ematologia e Terapia Cellulare - PO Mazzoni AST Ascoli PicenoRecruiting
Ascoli Piceno, Italy
Azienda Ospedaliera Spedali Civili di BresciaRecruiting
Brescia, Italy
Istituto Europeo di OncologiaRecruiting
Milan, Italy
Federico II UniversityRecruiting
Naples, Italy
AOU Maggiore della Carita-SCDU EmatologiaRecruiting
Novara, Italy
UO Ematologia RavennaRecruiting
Ravenna, Italy
Santa Maria della MisericordiaRecruiting
Udine, Italy
Ospedale dell'Angelo - VareseRecruiting
Varese, Italy
Specjalistyczny Szpital im A. Sokolowskiego w WalbrzychuRecruiting
Wałbrzych, Lower Silesian Voivodeship, Poland
Uniwersytecki Szpital KlinicznyRecruiting
Wroclaw, Lower Silesian Voivodeship, Poland
Pratia MCM KrakowRecruiting
Krakow, Malopolska, Poland
Uniwersyteckie Centrum KliniczneRecruiting
Gdansk, Pomeranian Voivodeship, Poland
AidportRecruiting
Skorzewo, Wielkopolska, Poland
Cm Pratia PoznanCompleted
Skorzewo, Wielkopolska, Poland
Pratia Onkologia KatowiceRecruiting
Katowice, Poland
Copernicus Memorial HospitalWithdrawn
Lodz, Poland
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w LublinieRecruiting
Lublin, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy WarszawaWithdrawn
Warsaw, Poland
Center for Hematologic MalignancyWithdrawn
Goyang-si, Gyeonggi-do, South Korea
St. Vincents Hospital - The Catholic University of KoreaRecruiting
Suwon, Gyeonggi-do, South Korea
Ajou University HospitalRecruiting
Suwon, Gyeonggi-do, South Korea
Jeonbuk National University HospitalWithdrawn
Jeonju, Jeollabuk-do, South Korea
Dong-A University HospitalCompleted
Busan, South Korea
Pusan National University HospitalRecruiting
Busan, South Korea
Kyungpook National University Chilgok HospitalWithdrawn
Daegu, South Korea
Seoul St. Mary's HospitalWithdrawn
Seoul, South Korea
University Hospital of Santiago de CompostelaRecruiting
Santiago de Compostela, A Coruna, Spain
Hospital Universitario Virgen De La Victoria MalagaRecruiting
Málaga, Andalusia, Spain
Hospital Universitario Virgen MacarenaRecruiting
Seville, Andalusia, Spain
Son Espases University HospitalWithdrawn
Palma, Balearic Islands, Spain
Cruces University Hospital (Hospital Universitario Cruces)Recruiting
Barakaldo, Bizkaia, Spain
Hospital Universitario Marques de ValdecillaRecruiting
Santander, Cantabria, Spain
Complejo Hospitalario Universitario de a CorunaWithdrawn
A Coruña, Galicia, Spain
Hospital Universitario Quironsalud MadridRecruiting
Pozuelo de Alarcón, Madrid, Spain
Hospital Clinico Universitario Virgen De La ArrixacaWithdrawn
El Palmar, Murcia, Spain
Hospital Universitario de NavarraRecruiting
Pamplona, Navarre, Spain
Hospital Universitario Central de AsturiasWithdrawn
Oviedo, Principality of Asturias, Spain
University Hospital Vall d'HebronRecruiting
Barcelona, Spain
Hospital de la Santa Creu i Sant PauRecruiting
Barcelona, Spain
Hospital Virgen De Las Nieves De GranadaRecruiting
Granada, Spain
Gregorio MaranonRecruiting
Madrid, Spain
Clinica Universidad de NavarraWithdrawn
Madrid, Spain
Clinica Universidad de NavarraRecruiting
Madrid, Spain
Fundacion Jimenez Diaz University HospitalRecruiting
Madrid, Spain
University Hospital & Research InstituteRecruiting
Madrid, Spain
Hospital Universitario HM Sanchinarro, Servicio de HematologiaRecruiting
Madrid, Spain
Morales Meseguer HospitalRecruiting
Murcia, Spain
Complexo Hospitalario Universitario de OurenseRecruiting
Ourense, Spain
Hospital Universitario de SalamancaRecruiting
Salamanca, Spain
University Hospital Virgen del RocioRecruiting
Seville, Spain
Hospital Universitario Virgen de ValmeRecruiting
Seville, Spain
Hospital General Universitario de ToledoWithdrawn
Toledo, Spain
Hospital Clinico Universitario ValenciaRecruiting
Valencia, Spain
Hospital Universitari and Politecnic La FeRecruiting
Valencia, Spain
Hospital Clinico Lozano BlesaRecruiting
Zaragoza, Spain
Kantonsspital BadenRecruiting
Baden, Canton of Aargau, Switzerland
Cantonal Hospital St GallenRecruiting
Sankt Gallen, Canton of St. Gallen, Switzerland
Kantonsspital Winterthur Medical OncologyRecruiting
Winterthur, Schweiz, Switzerland
University Hospital BaselRecruiting
Basel, Switzerland
Inselspital Bern University HospitalRecruiting
Bern, Switzerland
Chang Gung Medical Foundation Chia Yi BranchWithdrawn
Buzi, Chiayi County, Taiwan
Chang Gung Memorial Hospital LinkouRecruiting
Taoyuan, Guishan District, Taiwan
Changhua Christian HospitalRecruiting
Changhua, Taiwan
Chung-Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Kaohsiung Chang Gung Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Taipei Medical University-Shuang Ho HospitalRecruiting
New Taipei City, Taiwan
Taichung General Veterans HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Tri-Service General HospitalRecruiting
Taipei, Taiwan
Taipei Municipal Wan Fang HospitalRecruiting
Taipei, Taiwan
Ankara University Faculty of MedicineRecruiting
Mamak, Ankara, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Oncology Training and Research HospitalRecruiting
Yenimahalle, Ankara, Turkey (Türkiye)
Gazi UniversityRecruiting
Ankara, Central Anatolia, Turkey (Türkiye)
VM Medical Park Mersin HospitalRecruiting
Mezitli, Mersin, Turkey (Türkiye)
Tekirdag Namik Kemal University HospitalRecruiting
Tekirdağ, Suleymanpasa, Turkey (Türkiye)
Liv Hospital AnkaraRecruiting
Ankara, Turkey (Türkiye)
VKV American HopitalRecruiting
Istanbul, Turkey (Türkiye)
Istanbul University Istanbul Faculty of MedicineRecruiting
Istanbul, Turkey (Türkiye)
Ege UniversityRecruiting
Izmir, Turkey (Türkiye)
Erci̇yes Uni̇versi̇tyRecruiting
Kayseri, Turkey (Türkiye)
Sakarya University Medical FacultyRecruiting
Sakarya, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi HastanesiRecruiting
Samsun, Turkey (Türkiye)
Zonguldak Bulent Ecevit UniversityRecruiting
Zonguldak, Turkey (Türkiye)
Royal Cornwall Hospitals NHS TrustRecruiting
Truro, Cornwall, United Kingdom
Derriford Hospital and the Royal Eye InfirmaryWithdrawn
Plymouth, Devon, United Kingdom
University Hospitals DorsetRecruiting
Bournemouth, Dorset, United Kingdom
Beatson West of Scotland Cancer CentreRecruiting
Glasgow, Lanarkshire, United Kingdom
Norfolk and Norwich University HospitalRecruiting
Norwich, Norfolk, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS TrustRecruiting
Romford, United Kingdom