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

Description

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.

Interventions

• Odronextamab (Drug)
  Administered per the protocol
• Rituximab (Drug)
  Administered per the protocol
• Cyclophosphamide (Drug)
  Administered per the protocol as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy
• Doxorubicin (Drug)
  Administered per the protocol as part of CHOP chemotherapy
• Vincristine (Drug)
  Administered per the protocol as part of CHOP, and CVP chemotherapy
• Prednisone/prednisolone (Drug)
  Administered per the protocol as part of CVP chemotherapy
• Bendamustine (Drug)
  Administered per the protocol as part of chemotherapy (Rituximab-Bendamustine)

Eligibility criteria

Conditions

Locations

• 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
• Azienda Ospedaliera Spedali Civili di Brescia — Brescia, Italy
• Istituto Europeo di Oncologia — Milan, Italy
• Federico II University — Naples, 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 Sp. z o.o. — 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
• Jeonbuk National University Hospital — Jeonju, Jeollabuk-do, South Korea
• Dong-A University Hospital — Busan, South Korea
• Pusan National University Hospital — Busan, South Korea
• Kyungpook National University Chilgok Hospital — Daegu, 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
• 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 General Universitario de Toledo — Toledo, 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 City, 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, 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 Hospitals NHS Trust, Royal Cornwall Hospital — 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