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
Start Date
12/12/2023
Completion Date
11/3/2029
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 Criteria
Age Range: 18 years to No maximum
Interventions
Odronextamab
Rituximab
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone/prednisolone
Bendamustine
Conditions
Locations
University of Arizona Cancer Center
Tucson, Arizona 85724
United States
David Geffen School of Medicine at UCLA
Los Angeles, California 90095
United States
UC Irvine Health
Orange, California 92868
United States
Investigative Clinical Research of Indiana
Noblesville, Indiana 46062
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Hattiesburg Clinic
Hattiesburg, Mississippi 39401
United States
Icahn School of Medicine at Mt Sinai
New York, New York 10029
United States
Stony Brook University Hospital
Stony Brook, New York 11794
United States
Clinical Research Alliance Inc
Westbury, New York 11590
United States
University of North Carolina
Chapel Hill, North Carolina 27514
United States
Levine Cancer Institute
Charlotte, North Carolina 28207
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Center for Oncology and Blood Disorders
Houston, Texas 77030
United States
HOPE Cancer Center of East Texas
Tyler, Texas 75701
United States
Huntsman Cancer Institute - Oncology Division
Salt Lake City, Utah 84112
United States
University of Virginia
Charlottesville, Virginia 22908
United States
Virginia Commonwealth University
Richmond, Virginia 23219
United States
Prohealth Care Inc
Waukesha, Wisconsin 53188
United States
Ingham Institute
Liverpool, New South Wales 2170
Australia
Icon Cancer Centre - Wesley
Auchenflower, Queensland 4066
Australia
Flinders Medical Centre
Bedford Park, South Australia 5042
Australia
Monash Health
Clayton, Victoria 3168
Australia
Epworth Freemasons
East Melbourne, Victoria 3121
Australia
St Vincent's Hospital - Melbourne
Fitzroy, Victoria 3065
Australia
Alfred Hospital and Monash University
Melbourne, Victoria 3004
Australia
Ordensklinikum Linz
Linz, Osterreich 4010
Austria
Ordensklinikum Linz Gmbh, Elisabethinen
Linz, 4020
Austria
Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III
Salzburg, 5020
Austria
Medical University of Vienna
Vienna, 1090
Austria
Hanusch Krankenhaus
Vienna, 1140
Austria
AZ St.-Elisabeth Herentals vzw
Herentals, Antwerp 2200
Belgium
Hopital De Jolimont
La Louvière, Hainaut 7100
Belgium
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent, Oost-Vlaanderen 9000
Belgium
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, 2060
Belgium
Institut Jules Bordet
Brussels, 1000
Belgium
Ensino e Terapia de Inovacao Clinica Amo (Etica)
Salvador, Estado de Bahia 41950640
Brazil
Instituto Mario Pena de Ensino Pesquisa e Inovacao
Belo Horizonte, Minas Gerais 30380-420
Brazil
Liga Norte Riograndense Contra o Cancer
Natal, Rio Grande do Norte 59062-000
Brazil
Instituto do Cancer em Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul 99010-080
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul 90035-903
Brazil
Centro de Hematologia e Oncologia
Joinville, Santa Catarina 89201260
Brazil
Animi Unidade de Tratamento Oncologico Ltda
Lages, Santa Catarina 88501-001
Brazil
Fundacao Pio XII Hospital de Amor
Barretos, São Paulo 14784-400
Brazil
Amaral Carvalho Hospital
Jaú, São Paulo 17210080
Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirão Preto, São Paulo 14048-900
Brazil
Instituto DOr de Pesquisa e Ensino Df Star
Brasília, 70390-140
Brazil
Instituto Nacional de Cancer Jose Alencar Gomes da Silva
Rio de Janeiro, 20231050
Brazil
Instituto Americas
Rio de Janeiro, 22793-334
Brazil
Hospital Alemao Oswaldo Cruz
São Paulo, 01323-903
Brazil
AC Camargo Cancer Center
São Paulo, 01509010
Brazil
Clinical Hospital of Medicine School at Sao Paulo University
São Paulo, 05403-000
Brazil
Casa de Saude Santa Marcelina
São Paulo, 08270-070
Brazil
Tom Baker Cancer Center
Calgary, Alberta T2N 4J8
Canada
Saint John Regional Hospital
Saint John, New Brunswick E2L 4L2
Canada
Centre Integre de Sante et de Services Sociaux (CISSS) de la Monteregie-Centre
Greenfield Park, Quebec J4V 2H1
Canada
CHU de Quebec - Universite Laval
Québec, Quebec G1J1Z4
Canada
Ciusss de Lestrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec J1H 5N4
Canada
Fundacion Arturo Lopez Perez
Santiago, Santiago Metropolitan 7500921
Chile
Centro Oncologia de Precision Universidad Mayor
Santiago, Santiago Metropolitan 7560907
Chile
Inmunocel
Santiago, Santiago Metropolitan 7580206
Chile
Clinica Alemana de Santiago
Santiago, Santiago Metropolitan 7650620
Chile
University Hospital Hradec Kralove
Hradec Králové, 50005
Czechia
University Hospital Kralovske Vinohrady
Prague, 10034
Czechia
Vseobecna Fakultni Nemocnice
Prague, 12808
Czechia
Centre Hospitalier Universitaire (CHU) Rennes
Rennes, Brittany Region 35033
France
Centre Hospitalier Regional Universitaire de Tours
Tours, Centre-Val de Loire 37044
France
Nantes University Hospital
Nantes, Pays de la Loire Region 44093
France
Hopital de la Conception
Marseille, Provence-Alpes-Côte d'Azur Region 13005
France
Centre Hospitalier Universitaire Angers
Angers, 49933
France
Institut Paoli Calmettes
Marseille, 13009
France
Hopital Saint Louis
Paris, 75010
France
Hopital Saint-Antoine
Paris, 755710
France
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, 86021
France
Institut de Cancerologie Strasbourg Europe (ICANS)
Strasbourg, 67033
France
Hopital Victor Dupouy Argenteuil
Argenteuil, Île-de-France Region 95100
France
Gustave Roussy
Villejuif, Île-de-France Region 94800
France
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg 70376
Germany
University Hospital Wurzburg
Würzburg, Bavaria 97080
Germany
Kliniken Ostalb Stauferklinikum Schwab Gmund
Mutlangen, Gmund D-73557
Germany
Clinic Frankfurt (Oder)
Frankfurt am Main, Hesse 15236
Germany
Universitatsmedizin der Johannes-Gutenberg Universitat Mainz
Mainz, Rhineland-Palatinate 55131
Germany
Hematological Praxis Dresden
Dresden, Saxony 01307
Germany
Charite Universitatsmedizin Berlin Campus Benjamin Franklin
Berlin, 12203
Germany
University Hospital Carl Gustav Carus
Dresden, 01307
Germany
Stadtisches Krankenhaus Kiel
Kiel, 24116
Germany
Samson Assuta Ashdod University Hospital
Ashdod, 7747629
Israel
Bnai Zion Medical Center
Haifa, 31048
Israel
Hadassah Medical Center
Jerusalem, 91200
Israel
Galilee Medical Center
Nahariya, 2210001
Israel
Rabin Medical Center
Petah Tikva, 4941492
Israel
Chaim Sheba Medical Center
Ramat Gan, 5265601
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Israel
Istituto Romagnolo Per Lo Studio Dei Tumori
Meldola, Forli Cesena 47014
Italy
Pia Fondazione Panico
Tricase, Lecce 73039
Italy
IRCCS Ospedale Policlinico San Martino
Genoa, Liguria 16132
Italy
Candiolo Cancer Institute, FPO, IRCCS
Candiolo, Torino 10060
Italy
UOC Ematologia e Terapia Cellulare - PO Mazzoni AST Ascoli Piceno
Ascoli Piceno, 63100
Italy
Irccs Aou Di Bologna - Policlinico Di Sant'orsola Malpighi
Bologna, 40138
Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
Italy
Istituto Europeo di Oncologia
Milan, 20141
Italy
Federico II University
Naples, 80131
Italy
AOU Maggiore della Carita-SCDU Ematologia
Novara, 28100
Italy
UO Ematologia Ravenna
Ravenna, 48121
Italy
Santa Maria della Misericordia
Udine, 33100
Italy
Ospedale dell'Angelo - Varese
Varese, 21100
Italy
Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu
Wałbrzych, Lower Silesian Voivodeship 58-309
Poland
Uniwersytecki Szpital Kliniczny
Wroclaw, Lower Silesian Voivodeship 50-367
Poland
Pratia MCM Krakow
Krakow, Malopolska 30-510
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship 80-952
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Aidport
Skorzewo, Wielkopolska 60185
Poland
Cm Pratia Poznan
Skorzewo, Wielkopolska 60185
Poland
Pratia Onkologia Katowice
Katowice, 40-519
Poland
Copernicus Memorial Hospital
Lodz, 93-513
Poland
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-954
Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa
Warsaw, 02781
Poland
Center for Hematologic Malignancy
Goyang-si, Gyeonggi-do 10408
South Korea
St. Vincents Hospital - The Catholic University of Korea
Suwon, Gyeonggi-do 16247
South Korea
Ajou University Hospital
Suwon, Gyeonggi-do 16499
South Korea
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do 54907
South Korea
Dong-A University Hospital
Busan, 49201
South Korea
Pusan National University Hospital
Busan, 49241
South Korea
Kyungpook National University Chilgok Hospital
Daegu, 41404
South Korea
Seoul St. Mary's Hospital
Seoul, 06591
South Korea
University Hospital of Santiago de Compostela
Santiago de Compostela, A Coruna 15706
Spain
Hospital Universitario Virgen De La Victoria Malaga
Málaga, Andalusia 29010
Spain
Hospital Universitario Virgen Macarena
Seville, Andalusia 41009
Spain
Son Espases University Hospital
Palma, Balearic Islands 07120
Spain
Cruces University Hospital (Hospital Universitario Cruces)
Barakaldo, Bizkaia 48903
Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
Spain
Complejo Hospitalario Universitario de a Coruna
A Coruña, Galicia 15006
Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid 28223
Spain
Hospital Clinico Universitario Virgen De La Arrixaca
El Palmar, Murcia 30120
Spain
Hospital Universitario de Navarra
Pamplona, Navarre 31008
Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias 33011
Spain
University Hospital Vall d'Hebron
Barcelona, 08035
Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Spain
Hospital Virgen De Las Nieves De Granada
Granada, 18014
Spain
Gregorio Maranon
Madrid, 28007
Spain
Clinica Universidad de Navarra
Madrid, 28027
Spain
Clinica Universidad de Navarra
Madrid, 28027
Spain
Fundacion Jimenez Diaz University Hospital
Madrid, 28040
Spain
University Hospital & Research Institute
Madrid, 28041
Spain
Hospital Universitario HM Sanchinarro, Servicio de Hematologia
Madrid, 28050
Spain
Morales Meseguer Hospital
Murcia, 30008
Spain
Complexo Hospitalario Universitario de Ourense
Ourense, 32005
Spain
Hospital Universitario de Salamanca
Salamanca, 37007
Spain
University Hospital Virgen del Rocio
Seville, 41013
Spain
Hospital Universitario Virgen de Valme
Seville, 41014
Spain
Hospital General Universitario de Toledo
Toledo, 45007
Spain
Hospital Clinico Universitario Valencia
Valencia, 46010
Spain
Hospital Universitari and Politecnic La Fe
Valencia, 46026
Spain
Hospital Clinico Lozano Blesa
Zaragoza, 50009
Spain
Kantonsspital Baden
Baden, Canton of Aargau 5404
Switzerland
Cantonal Hospital St Gallen
Sankt Gallen, Canton of St. Gallen 9007
Switzerland
Kantonsspital Winterthur Medical Oncology
Winterthur, Schweiz 8401
Switzerland
University Hospital Basel
Basel, 4031
Switzerland
Inselspital Bern University Hospital
Bern, 3010
Switzerland
Chang Gung Medical Foundation Chia Yi Branch
Buzi, Chiayi County 613
Taiwan
Chang Gung Memorial Hospital Linkou
Taoyuan City, Guishan District 333
Taiwan
Changhua Christian Hospital
Changhua, 500-06
Taiwan
Chung-Ho Memorial Hospital
Kaohsiung City, 80756
Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Taiwan
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 235
Taiwan
Taichung General Veterans Hospital
Taichung, 40705
Taiwan
National Cheng Kung University Hospital
Tainan, 704
Taiwan
National Taiwan University Hospital
Taipei, 100225
Taiwan
Taipei Veterans General Hospital
Taipei, 11217
Taiwan
Tri-Service General Hospital
Taipei, 114
Taiwan
Taipei Municipal Wan Fang Hospital
Taipei, 116
Taiwan
Ankara University Faculty of Medicine
Mamak, Ankara 06620
Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Yenimahalle, Ankara 06200
Turkey (Türkiye)
Gazi University
Ankara, Central Anatolia 06100
Turkey (Türkiye)
VM Medical Park Mersin Hospital
Mezitli, Mersin 33200
Turkey (Türkiye)
Tekirdag Namik Kemal University Hospital
Tekirdağ, Suleymanpasa 59100
Turkey (Türkiye)
Liv Hospital Ankara
Ankara, 06100
Turkey (Türkiye)
VKV American Hopital
Istanbul, 34365
Turkey (Türkiye)
Istanbul University Istanbul Faculty of Medicine
Istanbul, 34418
Turkey (Türkiye)
Ege University
Izmir, 35100
Turkey (Türkiye)
Erci̇yes Uni̇versi̇ty
Kayseri, 38039
Turkey (Türkiye)
Sakarya University Medical Faculty
Sakarya, 54290
Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55239
Turkey (Türkiye)
Zonguldak Bulent Ecevit University
Zonguldak, 67100
Turkey (Türkiye)
Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital
Truro, Cornwall TR1 3LJ
United Kingdom
Derriford Hospital and the Royal Eye Infirmary
Plymouth, Devon PL6 8DH
United Kingdom
University Hospitals Dorset
Bournemouth, Dorset BH77DW
United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, Lanarkshire G12 0YN
United Kingdom
Norfolk and Norwich University Hospital
Norwich, Norfolk NR4 7UY
United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
Romford, RM7 0AG
United Kingdom