Follicular Lymphoma Clinical Trials

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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)

Status: Recruiting
Location: See all (187) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of Cluster of Differentiation 20\^+ (CD20\^+) FL Grade 1-3a, stage II bulky or stage III / IV

• Need for treatment as described in the protocol

• Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

• Adequate bone marrow function and hepatic function, as described in the protocol

Locations
United States
Arizona
University of Arizona Cancer Center
RECRUITING
Tucson
California
David Geffen School of Medicine at UCLA
RECRUITING
Los Angeles
UC Irvine Health
WITHDRAWN
Orange
Indiana
Investigative Clinical Research of Indiana
RECRUITING
Noblesville
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Mississippi
Hattiesburg Clinic
COMPLETED
Hattiesburg
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
Levine Cancer Institute
RECRUITING
Charlotte
New York
Icahn School of Medicine at Mt Sinai
RECRUITING
New York
Stony Brook University Hospital
RECRUITING
Stony Brook
Clinical Research Alliance Inc
WITHDRAWN
Westbury
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Center for Oncology and Blood Disorders
RECRUITING
Houston
HOPE Cancer Center of East Texas
WITHDRAWN
Tyler
Utah
Huntsman Cancer Institute - Oncology Division
RECRUITING
Salt Lake City
Virginia
University of Virginia
RECRUITING
Charlottesville
Virginia Commonwealth University
WITHDRAWN
Richmond
Wisconsin
Prohealth Care Inc
WITHDRAWN
Waukesha
Other Locations
Australia
Icon Cancer Centre - Wesley
RECRUITING
Auchenflower
Flinders Medical Centre
RECRUITING
Bedford Park
Monash Health
RECRUITING
Clayton
Epworth Freemasons
RECRUITING
East Melbourne
St Vincent's Hospital - Melbourne
RECRUITING
Fitzroy
Ingham Institute
RECRUITING
Liverpool
Alfred Hospital and Monash University
RECRUITING
Melbourne
Austria
Ordensklinikum Linz
RECRUITING
Linz
Ordensklinikum Linz Gmbh, Elisabethinen
RECRUITING
Linz
Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III
RECRUITING
Salzburg
Hanusch Krankenhaus
RECRUITING
Vienna
Medical University of Vienna
RECRUITING
Vienna
Belgium
Ziekenhuis Netwerk Antwerpen Stuivenberg
WITHDRAWN
Antwerp
Institut Jules Bordet
WITHDRAWN
Brussels
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
WITHDRAWN
Ghent
AZ St.-Elisabeth Herentals vzw
RECRUITING
Herentals
Hopital De Jolimont
WITHDRAWN
La Louvière
Brazil
Fundacao Pio XII Hospital de Amor
RECRUITING
Barretos
Instituto Mario Pena de Ensino Pesquisa e Inovacao
RECRUITING
Belo Horizonte
Instituto DOr de Pesquisa e Ensino Df Star
RECRUITING
Brasília
Amaral Carvalho Hospital
RECRUITING
Jaú
Centro de Hematologia e Oncologia
RECRUITING
Joinville
Animi Unidade de Tratamento Oncologico Ltda
RECRUITING
Lages
Liga Norte Riograndense Contra o Cancer
RECRUITING
Natal
Instituto do Cancer em Hospital Sao Vicente de Paulo
RECRUITING
Passo Fundo
Hospital de Clinicas de Porto Alegre
RECRUITING
Porto Alegre
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
RECRUITING
Ribeirão Preto
Instituto Americas
RECRUITING
Rio De Janeiro
Instituto Nacional de Cancer Jose Alencar Gomes da Silva
RECRUITING
Rio De Janeiro
Ensino e Terapia de Inovacao Clinica Amo (Etica)
RECRUITING
Salvador
AC Camargo Cancer Center
RECRUITING
São Paulo
Casa de Saude Santa Marcelina
RECRUITING
São Paulo
Clinical Hospital of Medicine School at Sao Paulo University
RECRUITING
São Paulo
Hospital Alemao Oswaldo Cruz
RECRUITING
São Paulo
Canada
Tom Baker Cancer Center
RECRUITING
Calgary
Centre Integre de Sante et de Services Sociaux (CISSS) de la Monteregie-Centre
RECRUITING
Greenfield Park
CHU de Quebec - Universite Laval
RECRUITING
Québec
Saint John Regional Hospital
RECRUITING
Saint John
Ciusss de Lestrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)
RECRUITING
Sherbrooke
Chile
Centro Oncologia de Precision Universidad Mayor
WITHDRAWN
Santiago
Clinica Alemana de Santiago
RECRUITING
Santiago
Fundacion Arturo Lopez Perez
RECRUITING
Santiago
Inmunocel
RECRUITING
Santiago
France
Centre Hospitalier Universitaire Angers
RECRUITING
Angers
Hopital Victor Dupouy Argenteuil
RECRUITING
Argenteuil
Hopital de la Conception
RECRUITING
Marseille
Institut Paoli Calmettes
RECRUITING
Marseille
Nantes University Hospital
RECRUITING
Nantes
Hopital Saint Louis
RECRUITING
Paris
Hopital Saint-Antoine
RECRUITING
Paris
Centre Hospitalier Universitaire (CHU) de Poitiers
RECRUITING
Poitiers
Centre Hospitalier Universitaire (CHU) Rennes
RECRUITING
Rennes
Institut de Cancerologie Strasbourg Europe (ICANS)
RECRUITING
Strasbourg
Centre Hospitalier Regional Universitaire de Tours
RECRUITING
Tours
Gustave Roussy
RECRUITING
Villejuif
Germany
Charite Universitatsmedizin Berlin Campus Benjamin Franklin
RECRUITING
Berlin
Hematological Praxis Dresden
RECRUITING
Dresden
University Hospital Carl Gustav Carus
RECRUITING
Dresden
Clinic Frankfurt (Oder)
RECRUITING
Frankfurt Am Main
Stadtisches Krankenhaus Kiel
RECRUITING
Kiel
Universitatsmedizin der Johannes-Gutenberg Universitat Mainz
RECRUITING
Mainz
Kliniken Ostalb Stauferklinikum Schwab Gmund
RECRUITING
Mutlangen
Robert-Bosch-Krankenhaus
WITHDRAWN
Stuttgart
University Hospital Wurzburg
RECRUITING
Würzburg
Israel
Samson Assuta Ashdod University Hospital
RECRUITING
Ashdod
Bnai Zion Medical Center
RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
Galilee Medical Center
RECRUITING
Nahariya
Rabin Medical Center
RECRUITING
Petah Tikva
Chaim Sheba Medical Center
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Italy
UOC Ematologia e Terapia Cellulare - PO Mazzoni AST Ascoli Piceno
RECRUITING
Ascoli Piceno
Irccs Aou Di Bologna- Policlinico Di Sant'Orsola Malpighi
RECRUITING
Bologna
Azienda Ospedaliera Spedali Civili di Brescia
RECRUITING
Brescia
Candiolo Cancer Institute, FPO, IRCCS
RECRUITING
Candiolo
IRCCS Ospedale Policlinico San Martino
RECRUITING
Genoa
Istituto Romagnolo Per Lo Studio Dei Tumori
RECRUITING
Meldola
Istituto Europeo di Oncologia
RECRUITING
Milan
Federico II University
RECRUITING
Naples
AOU Maggiore della Carita-SCDU Ematologia
RECRUITING
Novara
UO Ematologia Ravenna
RECRUITING
Ravenna
Pia Fondazione Panico
RECRUITING
Tricase
Santa Maria della Misericordia
RECRUITING
Udine
Ospedale dell'Angelo - Varese
RECRUITING
Varese
Poland
Uniwersyteckie Centrum Kliniczne
RECRUITING
Gdansk
Pratia Onkologia Katowice
RECRUITING
Katowice
Pratia MCM Krakow
RECRUITING
Krakow
Copernicus Memorial Hospital
WITHDRAWN
Lodz
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
RECRUITING
Lublin
Aidport
RECRUITING
Skorzewo
Cm Pratia Poznan
COMPLETED
Skorzewo
Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu
RECRUITING
Wałbrzych
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa
WITHDRAWN
Warsaw
Uniwersytecki Szpital Kliniczny
RECRUITING
Wroclaw
Republic of Korea
Dong-A University Hospital
COMPLETED
Busan
Pusan National University Hospital
RECRUITING
Busan
Kyungpook National University Chilgok Hospital
WITHDRAWN
Daegu
Center for Hematologic Malignancy
WITHDRAWN
Goyang-si
Jeonbuk National University Hospital
WITHDRAWN
Jeonju
Seoul St. Mary's Hospital
WITHDRAWN
Seoul
Ajou University Hospital
RECRUITING
Suwon
St. Vincents Hospital - The Catholic University of Korea
RECRUITING
Suwon
Spain
Complejo Hospitalario Universitario de a Coruna
WITHDRAWN
A Coruña
Cruces University Hospital (Hospital Universitario Cruces)
RECRUITING
Barakaldo
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
University Hospital Vall d'Hebron
RECRUITING
Barcelona
Hospital Clinico Universitario Virgen De La Arrixaca
WITHDRAWN
El Palmar
Hospital Virgen De Las Nieves De Granada
RECRUITING
Granada
Clinica Universidad de Navarra
RECRUITING
Madrid
Clinica Universidad de Navarra
WITHDRAWN
Madrid
Fundacion Jimenez Diaz University Hospital
RECRUITING
Madrid
Gregorio Maranon
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro, Servicio de Hematologia
RECRUITING
Madrid
University Hospital & Research Institute
RECRUITING
Madrid
Hospital Universitario Virgen De La Victoria Malaga
RECRUITING
Málaga
Morales Meseguer Hospital
RECRUITING
Murcia
Complexo Hospitalario Universitario de Ourense
RECRUITING
Ourense
Hospital Universitario Central de Asturias
WITHDRAWN
Oviedo
Son Espases University Hospital
WITHDRAWN
Palma
Hospital Universitario de Navarra
RECRUITING
Pamplona
Hospital Universitario Quironsalud Madrid
RECRUITING
Pozuelo De Alarcón
Hospital Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Marques de Valdecilla
RECRUITING
Santander
University Hospital of Santiago de Compostela
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen de Valme
RECRUITING
Seville
Hospital Universitario Virgen Macarena
RECRUITING
Seville
University Hospital Virgen del Rocio
RECRUITING
Seville
Hospital General Universitario de Toledo
WITHDRAWN
Toledo
Hospital Clinico Universitario Valencia
RECRUITING
Valencia
Hospital Universitari and Politecnic La Fe
RECRUITING
Valencia
Hospital Clinico Lozano Blesa
RECRUITING
Zaragoza
Switzerland
Kantonsspital Baden
RECRUITING
Baden
University Hospital Basel
RECRUITING
Basel
Inselspital Bern University Hospital
RECRUITING
Bern
Cantonal Hospital St Gallen
RECRUITING
Sankt Gallen
Kantonsspital Winterthur Medical Oncology
RECRUITING
Winterthur
Taiwan
Chang Gung Medical Foundation Chia Yi Branch
WITHDRAWN
Buzi
Changhua Christian Hospital
RECRUITING
Changhua
Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Kaohsiung City
Taipei Medical University-Shuang Ho Hospital
RECRUITING
New Taipei City
Taichung General Veterans Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Municipal Wan Fang Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Tri-Service General Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital Linkou
RECRUITING
Taoyuan
Turkey
Gazi University
RECRUITING
Ankara
Liv Hospital Ankara
RECRUITING
Ankara
Istanbul University Istanbul Faculty of Medicine
RECRUITING
Istanbul
VKV American Hopital
RECRUITING
Istanbul
Ege University
RECRUITING
Izmir
Erci̇yes Uni̇versi̇ty
RECRUITING
Kayseri
Ankara University Faculty of Medicine
RECRUITING
Mamak
VM Medical Park Mersin Hospital
RECRUITING
Mezitli
Sakarya University Medical Faculty
RECRUITING
Sakarya
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
RECRUITING
Samsun
Tekirdag Namik Kemal University Hospital
RECRUITING
Tekirdağ
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
RECRUITING
Yenimahalle
Zonguldak Bulent Ecevit University
RECRUITING
Zonguldak
United Kingdom
University Hospitals Dorset
RECRUITING
Bournemouth
Beatson West of Scotland Cancer Centre
RECRUITING
Glasgow
Norfolk and Norwich University Hospital
RECRUITING
Norwich
Derriford Hospital and the Royal Eye Infirmary
WITHDRAWN
Plymouth
Barking, Havering and Redbridge University Hospitals NHS Trust
RECRUITING
Romford
Royal Cornwall Hospitals NHS Trust
RECRUITING
Truro
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2023-12-12
Estimated Completion Date: 2029-11-03
Participants
Target number of participants: 822
Treatments
Experimental: Odronextamab
Part 1 is a safety run-in. All participants will receive odronextamab.~In part 2 participants will be randomly assigned in a 1:1 ratio to receive odronextamab followed by odronextamab maintenance.
Active_comparator: Rituximab + Investigator's Choice Chemotherapy
Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance.
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov

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