A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma
Start Date
12/28/2023
Completion Date
1/23/2029
Summary
This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (called "relapsed"), or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's lymphoma (NHL). This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before. The aim of Part 2, of the study is to assess how well the combination of the study drug and lenalidomide works compared to the combination of rituximab (called "the comparator drug") and lenalidomide. The combination of comparator drug and lenalidomide is the current standard-of-care treatment for relapsed/refractory FL and/or MZL. 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 in combination with lenalidomide * 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) * The impact from the study drug on quality-of-life and ability to complete routine daily activities
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Odronextamab
Lenalidomide
Rituximab
Conditions
Locations
David Geffen School of Medicine at UCLA
Los Angeles, California 90095
United States
Boca Raton Clinical Research (BRCR) Global
Plantation, Florida 33322
United States
Indiana University and Comprehensive Cancer Center
Indianapolis, Indiana 46202
United States
Hattiesburg Clinic
Hattiesburg, Mississippi 39401
United States
Dartmouth Cancer Center
Lebanon, New Hampshire 03756
United States
Stony Brook University Hospital
Stony Brook, New York 11794
United States
Clinical Research Alliance Inc
Westbury, New York 11590
United States
Prohealth Care Inc
Waukesha, Wisconsin 53188
United States
Liverpool Hospital
Liverpool, New South Wales 2170
Australia
Calvary Mater Newcastle
Waratah, New South Wales 2298
Australia
Pindara Private Hospital
Benowa, Queensland 4217
Australia
Royal Hobart Hospital
Hobart, Tasmania 7000
Australia
Epworth Freemasons
East Melbourne, Victoria 3121
Australia
Ordensklinikum Linz
Linz, Osterreich 4020
Austria
Kepler University Hospital
Linz, Upper Austria 4020
Austria
Medical University Vienna
Vienna, 1090
Austria
Klinikum Wels-Grieskirchen
Wels, 4600
Austria
Centre Hospitalier Universitaire at Universite Catholique de Louvain Namur
Yvoir, Namur 5530
Belgium
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent, Oost-Vlaanderen 9000
Belgium
Algemeen Ziekenhuis AZ Delta
Roeselare, West-Vlaanderen 8800
Belgium
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, 2060
Belgium
Institut Jules Bordet
Brussels, 1000
Belgium
Hospital Sao Rafael
Salvador, Estado de Bahia 40285-000
Brazil
Hospital Sirio Libanes Brasilia
Brasília, Federal District 70200-730
Brazil
Uopeccan Hospital do Cancer de Cascavel
Cascavel, Paraná 85806-300
Brazil
Hospital Erasto Gaertner
Curitiba, Paraná 81520-060
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul 90035-903
Brazil
Centro Gaucho Integrado
Porto Alegre, Rio Grande do Sul 90110-270
Brazil
Amaral Carvalho Hospital
Jaú, São Paulo 17210-080
Brazil
Instituto Nacional de Cancer Jose Alencar Gomes da Silva
Rio de Janeiro, 20231050
Brazil
Hospital Sirio Libanes
São Paulo, 01308-050
Brazil
A Beneficencia Portuguesa de Sao Paulo, Oncology House
São Paulo, 01321000
Brazil
University Hospital Hradec Kralove
Hradec Králové, East Bohemia 50005
Czechia
Fakultni Nemocnice Brno
Brno, 62500
Czechia
University Hospital Kralovske Vinohrady
Prague, 10034
Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, 12808
Czechia
Institut Paoli-Calmettes
Marseille, Bouches Du Rhone 13009
France
CHU de Rennes
Rennes, Brittany Region 35033
France
Centre Hospitalier Regional Universitaire de Tours
Tours, Centre-Val de Loire 37044
France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, Gironde 33077
France
Centre Francois Magendie
Pessac, Gironde 33600
France
Hopital Saint Vincent-de-Paul
Lille, Nord 5900
France
Centre Henri Becquerel
Rouen, Normandy 76038
France
Nantes University Hospital
Nantes, Pays de la Loire Region 44093
France
Centre Hospitalier Metropole Savoie
Chambéry, Savoie 73000
France
Centre Hospitalier d'Avignon
Avignon, 84000
France
Centre Hospitalier Universitaire (CHU) Montpellier
Montpellier, 34290
France
Hopital Saint Louis
Paris, 75010
France
Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, 75571
France
Institut Curie
Saint-Cloud, 92210
France
Hopital Victor Dupouy Argenteuil
Argenteuil, Île-de-France Region 95100
France
Avicenne Hospital
Bobigny, Île-de-France Region 93000
France
Gustave Roussy
Villejuif, Île-de-France Region 94800
France
Stauferklinikum
Mutlangen, Baden-Wurttemberg 73557
Germany
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg 70376
Germany
LMU Klinikum
Munich, Bavaria 80337
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TUM Fakultat fur Medizin - Klinikum Rechts der Isar
Munich, Bavaria 81675
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Clinic Frankfurt (Oder)
Frankfurt am Main, Hesse 15236
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Universitatsmedizin der Johannes-Gutenberg Universitat Mainz
Mainz, Rhineland-Palatinate 55131
Germany
University Hospital Halle Saale
Halle, 6120
Germany
Stadtisches Krankenhaus Kiel
Kiel, 24116
Germany
MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
Neuss, 41462
Germany
Assuta Ashdod Medical Center
Ashdod, 7747629
Israel
Hadassah Medical Center
Jerusalem, 91200
Israel
Galilee Medical Center
Nahariya, 2210001
Israel
Rabin Medical Center
Petah Tikva, 49100
Israel
Chaim Sheba Medical Center
Ramat Gan, 5265601
Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Israel
Assuta Medical Centers
Tel Aviv, 6971028
Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Forli-Cesena 47014
Italy
Ospedale Policlinico San Martino IRCCS
Genoa, Genova 16132
Italy
S Gerardo Hospital
Monza, Monza E Brianza 20900
Italy
A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont 10126
Italy
Centro Di Riferimento Oncologico (CRO), Aviano, National Cancer Institute
Aviano, Pordenone 33081
Italy
Candiolo Cancer Institute, FPO, IRCCS
Candiolo, Torino 10060
Italy
University of Bologna Dipartimento di Medicina Specialistica Diagnostica e Sperimentale
Bologna, 40138
Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
Italy
ASST Grande Ospedale Metropolitano Niguarda - Main Address
Milan, 20162
Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
Italy
Istituto Europeo di Oncologia
Milan, 20141
Italy
A.O.U. di Modena
Modena, 41124
Italy
Federico II University
Naples, 80131
Italy
AOU Maggiore della Carita
Novara, 28100
Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Italy
Azienda Ospedaliera di Perugia
Perugia, 06132
Italy
Ospedale Santa Maria delle Croci
Ravenna, 48121
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Santa Maria della Misericordia
Udine, 33100
Italy
Hospital Sultanah Aminah Jhor Bahru
Johor Bahru, Johor 80100
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University of Malaya Medical Centre
Kuala Lumpur, Negeri / Wilayah Persekutuan 50603
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Hospital Queen Elizabeth
Kota Kinabalu, Sabah 88586
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Hospital Ampang
Ampang, Selangor 68000
Malaysia
Subang Jaya Medical Center
Subang Jaya, Selangor 47500
Malaysia
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Lublin, Lublin Voivodeship 20-090
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Pratia MCM Krakow
Krakow, Malopolska 30-510
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Pratia Poznan Medical Center
Poznan, Wielkopolska 60185
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Aidport
Skorzewo, Wielkopolska 60185
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Szpital Uniwersytecki Nr2 Bydgoszcz
Bydgoszcz, 85-168
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Pratia Onkologia Katowice
Katowice, 40-519
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Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)
Lodz, 93-513
Poland
Narodowy Instytut Onkologii
Warsaw, 02-781
Poland
St. Vincents Hospital - The Catholic University of Korea
Suwon, Gyeonggi-do 16247
South Korea
Jeonbuk National University Hospital
Jeonju, Jeollabuk 54907
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Gachon University Gil Medical Center
Incheon, Namdong-Gu 21565
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Inje University Busan Paik Hospital
Busan, 47392
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Pusan National University Hospital
Busan, 49241
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Yeyungnam University Medical Center
Daegu, 42415
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Seoul, 06351
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Yeouido St. Marys Hospital
Seoul, 07345
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Seoul St Marys Hospital
Seoul, 137-701
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Seoul, 3080
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Ulsan University Hospital
Ulsan, 44033
South Korea
University Hospital of Santiago de Compostela
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Son Espases University Hospital
Palma, Balearic Islands 07120
Spain
Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Barcelona 08908
Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
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Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid 28223
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Hospital Universitario Central de Asturias
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University Hospital Vall d'Hebron
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Hospital Clinic de Barcelona
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Hospital de la Santa Creu i Sant Pau
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Hospital Virgen De Las Nieves De Granada
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Hospital Universitario Ramon y Cajal
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Fundacion Jimenez Diaz University Hospital
Madrid, 28040
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Hospital Universitario12 de Octubre
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Hospital Universitario HM Sanchinarro
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Spain
Hospital Universitario de Salamanca
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Spain
University Hospital Virgen del Rocio
Seville, 41013
Spain
Instituto Valenciano de Oncologia
Valencia, 46009
Spain
University Hospital Doctor Peset
Valencia, 46017
Spain
Chang Gung Medical Foundation Chia Yi Branch
Buzi, Chiayi County 613
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Changhua Christian Hospital
Changhua, 500-06
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Show Chwan Memorial Hospital
Changhua, 50008
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Kaohsiung Medical University Hospital
Kaohsiung City, 80756
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Chang Gung Memorial Hospital Kaohsiung
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Taipei Medical University - Shuang Ho Hospital
New Taipei City, 23561
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National Cheng Kung University Hospital
Tainan, 701
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National Taiwan University Hospital
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Taipei Veterans General Hospital
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Tri-Service General Hospital
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Chang Gung Memorial Hospital
Taoyuan City, 333
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Chulalongkorn University
Bangkok, Krung Thep Maha Nakhon [Bangko] 10330
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Sriraj Hospital
Bangkok, 10700
Thailand
Chiang Mai University
Chiang Mai, 50200
Thailand
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)
Istanbul University, Istanbul Medical Faculty
Istanbul, 34093
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Ege University
Izmir, 35100
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Dokuz Eylul University
Izmir, 35340
Turkey (Türkiye)
Sakarya University Medical Faculty
Sakarya, 54290
Turkey (Türkiye)
Ondokuz Mayıs University
Samsun, 55270
Turkey (Türkiye)
Zonguldak Bulent Ecevit University
Zonguldak, 67600
Turkey (Türkiye)
Royal Cornwall Hospitals NHS Trust
Truro, Cornwall TR1 3LJ
United Kingdom
Derriford Hospital and the Royal Eye Infirmary
Plymouth, Devon PL6 8DH
United Kingdom
University Hospitals Dorset
Bournemouth, Dorset BH7 7DW
United Kingdom
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Salisbury, Hampshire SP6 2ND
United Kingdom
The Hillingdon Hospital
Uxbridge, Middlesex UB8 3NN
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Sutton, Surrey SM2 5PT
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James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, NR31 6LA
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Barking, Havering and Redbridge University Hospitals NHS Trust
Romford, RM7 0AG
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South Warwickshire NHS Foundation Trust
Warwick, CV34 5BW
United Kingdom