Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
Sponsor: Regeneron Pharmaceuticals
Summary
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
822
Start Date
2023-12-12
Completion Date
2029-11-03
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
Odronextamab
Administered per the protocol
Rituximab
Administered per the protocol
Cyclophosphamide
Administered per the protocol as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy
Doxorubicin
Administered per the protocol as part of CHOP chemotherapy
Vincristine
Administered per the protocol as part of CHOP, and CVP chemotherapy
Prednisone/prednisolone
Administered per the protocol as part of CVP chemotherapy
Bendamustine
Administered per the protocol as part of chemotherapy (Rituximab-Bendamustine)
Locations (190)
University of Arizona Cancer Center
Tucson, Arizona, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
UC Irvine Health
Orange, California, United States
Investigative Clinical Research of Indiana
Noblesville, Indiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Icahn School of Medicine at Mt Sinai
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Clinical Research Alliance Inc
Westbury, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Center for Oncology and Blood Disorders
Houston, Texas, United States
HOPE Cancer Center of East Texas
Tyler, Texas, United States
Huntsman Cancer Institute - Oncology Division
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Prohealth Care Inc
Waukesha, Wisconsin, United States
Ingham Institute
Liverpool, New South Wales, Australia
Icon Cancer Centre - Wesley
Auchenflower, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Epworth Freemasons
East Melbourne, Victoria, Australia
Alfred Hospital and Monash University
Melbourne, Victoria, Australia
St Vincents Hospital Melbourne
Melbourne, Victoria, Australia
Ordensklinikum Linz
Linz, Osterreich, Austria
Ordensklinikum Linz Gmbh, Elisabethinen
Linz, Austria
Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III
Salzburg, Austria
Medical University of Vienna
Vienna, Austria
Hanusch Krankenhaus
Vienna, Austria
AZ St.-Elisabeth Herentals vzw
Herentals, Antwerp, Belgium
Hopital De Jolimont
La Louvière, Hainaut, Belgium
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent, Oost-Vlaanderen, Belgium
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, Belgium
Institut Jules Bordet
Brussels, Belgium
Ensino e Terapia de Inovacao Clinica Amo (Etica)
Salvador, Estado de Bahia, Brazil
Instituto Mario Pena de Ensino Pesquisa e Inovacao
Belo Horizonte, Minas Gerais, Brazil
Liga Norte Riograndense Contra o Cancer
Natal, Rio Grande do Norte, Brazil
Instituto do Cancer em Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Hematologia e Oncologia
Joinville, Santa Catarina, Brazil
Animi Unidade de Tratamento Oncologico Ltda
Lages, Santa Catarina, Brazil
Fundacao Pio XII Hospital de Amor
Barretos, São Paulo, Brazil
Amaral Carvalho Hospital
Jaú, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirão Preto, São Paulo, Brazil
Instituto DOr de Pesquisa e Ensino Df Star
Brasília, Brazil
Instituto Nacional de Cancer Jose Alencar Gomes da Silva
Rio de Janeiro, Brazil
Instituto Americas
Rio de Janeiro, Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, Brazil
AC Camargo Cancer Center
São Paulo, Brazil
Clinical Hospital of Medicine School at Sao Paulo University
São Paulo, Brazil
Casa de Saude Santa Marcelina
São Paulo, Brazil
Tom Baker Cancer Center
Calgary, Alberta, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Centre Integre de Sante et de Services Sociaux (CISSS) de la Monteregie-Centre
Greenfield Park, Quebec, Canada
CHU de Quebec - Universite Laval
Québec, Quebec, Canada
Ciusss de Lestrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, Canada
Fundacion Arturo Lopez Perez
Santiago, Santiago Metropolitan, Chile
Centro Oncologia de Precision Universidad Mayor
Santiago, Santiago Metropolitan, Chile
Inmunocel
Santiago, Santiago Metropolitan, Chile
Clinica Alemana de Santiago
Santiago, Santiago Metropolitan, Chile
University Hospital Hradec Kralove
Hradec Králové, Czechia
University Hospital Kralovske Vinohrady
Prague, Czechia
Vseobecna Fakultni Nemocnice
Prague, Czechia
Centre Hospitalier Universitaire (CHU) Rennes
Rennes, Brittany Region, France
Centre Hospitalier Regional Universitaire de Tours
Tours, Centre-Val de Loire, France
Nantes University Hospital
Nantes, Pays de la Loire Region, France
Hopital de la Conception
Marseille, Provence-Alpes-Côte d'Azur Region, France
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, Vienne, France
Centre Hospitalier Universitaire Angers
Angers, France
Institut Paoli Calmettes
Marseille, France
Hopital Saint Louis
Paris, France
Hopital Saint-Antoine
Paris, France
Institut de Cancerologie Strasbourg Europe (ICANS)
Strasbourg, France
Hopital Victor Dupouy Argenteuil
Argenteuil, Île-de-France Region, France
Gustave Roussy
Villejuif, Île-de-France Region, France
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany
University Hospital Wurzburg
Würzburg, Bavaria, Germany
Kliniken Ostalb Stauferklinikum Schwab Gmund
Mutlangen, Gmund, Germany
Clinic Frankfurt (Oder)
Frankfurt am Main, Hesse, Germany
Universitatsmedizin der Johannes-Gutenberg Universitat Mainz
Mainz, Rhineland-Palatinate, Germany
Hematological Praxis Dresden
Dresden, Saxony, Germany
Charite Universitatsmedizin Berlin Campus Benjamin Franklin
Berlin, Germany
University Hospital Carl Gustav Carus
Dresden, Germany
Stadtisches Krankenhaus Kiel
Kiel, Germany
Samson Assuta Ashdod University Hospital
Ashdod, Israel
Bnai Zion Medical Center
Haifa, Israel
Hadassah Medical Center
Jerusalem, Israel
Galilee Medical Center
Nahariya, Israel
Rabin Medical Center
Petah Tikva, Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Istituto Romagnolo Per Lo Studio Dei Tumori
Meldola, Forli Cesena, Italy
Pia Fondazione Panico
Tricase, Lecce, Italy
IRCCS Ospedale Policlinico San Martino
Genoa, Liguria, Italy
Candiolo Cancer Institute, FPO, IRCCS
Candiolo, Torino, Italy
UOC Ematologia e Terapia Cellulare - PO Mazzoni AST Ascoli Piceno
Ascoli Piceno, Italy
Irccs Aou Di Bologna - Policlinico Di Sant'orsola Malpighi
Bologna, Italy