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 Follicular Lymphoma
NCT ID: NCT06091254
Last Updated: 2025-10-01
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
462 participants
INTERVENTIONAL
2023-12-12
2031-11-06
Brief Summary
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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.
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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
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.
Odronextamab
Administered by intravenous infusion (IV)
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.
Rituximab
Rituximab will be administered by IV, or subcutaneously (SC)
Cyclophosphamide
Administered by IV as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy
Doxorubicin
Administered by IV as part of CHOP chemotherapy
Vincristine
Administered by IV as part of CHOP, and CVP chemotherapy
Prednisone/prednisolone
Administered orally (PO) as part of CVP chemotherapy
Bendamustine
Administered by IV as part of chemotherapy (Rituximab-Bendamustine)
Interventions
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Odronextamab
Administered by intravenous infusion (IV)
Rituximab
Rituximab will be administered by IV, or subcutaneously (SC)
Cyclophosphamide
Administered by IV as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy
Doxorubicin
Administered by IV as part of CHOP chemotherapy
Vincristine
Administered by IV as part of CHOP, and CVP chemotherapy
Prednisone/prednisolone
Administered orally (PO) as part of CVP chemotherapy
Bendamustine
Administered by IV as part of chemotherapy (Rituximab-Bendamustine)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
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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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
St Vincent's Hospital - Melbourne
Fitzroy, Victoria, Australia
Alfred Hospital and Monash University
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
Haine-Saint-Paul, 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
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
Inmunocel
Santiago, Santiago Metropolitan, Chile
Clinica Alemana de Santiago
Santiago, Santiago Metropolitan, Chile
Centro Oncologia de Precision Universidad Mayor
Santiago, , 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 Angers
Angers, , France
Institut Paoli Calmettes
Marseille, , France
Hopital Saint Louis
Paris, , France
Hopital Saint-Antoine
Paris, , France
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, , 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
Irccs Aou Di Bologna- Policlinico Di Sant'Orsola Malpighi
Bologna, Italia, 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
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Federico II University
Napoli, , Italy
AOU Maggiore della Carita-SCDU Ematologia
Novara, , Italy
UO Ematologia Ravenna
Ravenna, , Italy
Santa Maria della Misericordia
Udine, , Italy
Ospedale dell'Angelo - Varese
Varese, , Italy
Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu
Wałbrzych, Lower Silesian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny
Wroclaw, Lower Silesian Voivodeship, Poland
Pratia MCM Krakow
Krakow, Malopolska, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Aidport
Skorzewo, Wielkopolska, Poland
Cm Pratia Poznan
Skorzewo, Wielkopolska, Poland
Pratia Onkologia Katowice
Katowice, , Poland
Copernicus Memorial Hospital
Lodz, , Poland
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, , Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa
Warsaw, , Poland
Center for Hematologic Malignancy
Goyang-si, Gyeonggi-do, South Korea
St. Vincents Hospital - The Catholic University of Korea
Suwon, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Dong-A University Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Jeonbuk National University Hospital
Jeonju, , South Korea
Seoul St. Mary's Hospital
Seoul, , South Korea
University Hospital of Santiago de Compostela
Santiago de Compostela, A Coruna, Spain
Hospital Universitario Virgen De La Victoria Malaga
Málaga, Andalusia, Spain
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain
Son Espases University Hospital
Palma, Balearic Islands, Spain
Cruces University Hospital (Hospital Universitario Cruces)
Barakaldo, Bizkaia, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Complejo Hospitalario Universitario de a Coruna
A Coruña, Galicia, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Clinico Universitario Virgen De La Arrixaca
El Palmar, Murcia, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Central De Asturias
Oviedo, Principality of Asturias, Spain
University Hospital Vall d'Hebron
Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Virgen De Las Nieves De Granada
Granada, , Spain
Gregorio Maranon
Madrid, , Spain
Clinica Universidad de Navarra
Madrid, , Spain
Fundacion Jimenez Diaz University Hospital
Madrid, , Spain
University Hospital & Research Institute
Madrid, , Spain
Hospital Universitario HM Sanchinarro, Servicio de Hematologia
Madrid, , Spain
Morales Meseguer Hospital
Murcia, , Spain
Complexo Hospitalario Universitario de Ourense
Ourense, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
University Hospital Virgen del Rocio
Seville, , Spain
Hospital Universitario Virgen de Valme
Seville, , Spain
Hospital Clinico Universitario Valencia
Valencia, , Spain
Hospital Universitari and Politecnic La Fe
Valencia, , Spain
Hospital Clinico Lozano Blesa
Zaragoza, , Spain
Kantonsspital Baden
Baden, Canton of Aargau, Switzerland
Cantonal Hospital St Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Kantonsspital Winterthur Medical Oncology
Winterthur, Schweiz, Switzerland
University Hospital Basel
Basel, , Switzerland
Inselspital Bern University Hospital
Bern, , Switzerland
Chang Gung Medical Foundation Chia Yi Branch
Buzi, Chiayi County, Taiwan
Chang Gung Memorial Hospital Linkou
Taoyuan, Guishan District, Taiwan
Changhua Christian Hospital
Changhua, , Taiwan
Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City, , Taiwan
Taichung General Veterans Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Taipei Municipal Wan Fang Hospital
Taipei, , Taiwan
Ankara University Faculty of Medicine
Mamak, Ankara, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Yenimahalle, Ankara, Turkey (Türkiye)
Gazi University
Ankara, Central Anatolia, Turkey (Türkiye)
VM Medical Park Mersin Hospital
Mezitli, Mersin, Turkey (Türkiye)
Tekirdag Namik Kemal University Hospital
Tekirdağ, Suleymanpasa, Turkey (Türkiye)
Liv Hospital Ankara
Ankara, , Turkey (Türkiye)
VKV American Hopital
Istanbul, , Turkey (Türkiye)
Istanbul University Istanbul Faculty of Medicine
Istanbul, , Turkey (Türkiye)
Ege University
Izmir, , Turkey (Türkiye)
Erci̇yes Uni̇versi̇ty
Kayseri, , Turkey (Türkiye)
Sakarya University Medical Faculty
Sakarya, , Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, , Turkey (Türkiye)
Zonguldak Bulent Ecevit University
Zonguldak, , Turkey (Türkiye)
Royal Cornwall Hospital NHS Trust
Truro, Cornwall, United Kingdom
Derriford Hospital and the Royal Eye Infirmary
Plymouth, Devon, United Kingdom
University Hospitals Dorset
Bournemouth, Dorset, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Lanarkshire, United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
Romford, , United Kingdom
Countries
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Related Links
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OLYMPIA
Other Identifiers
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2022-502660-20-00
Identifier Type: CTIS
Identifier Source: secondary_id
R1979-HM-2298
Identifier Type: -
Identifier Source: org_study_id
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