Actively Recruiting
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
Led by Regeneron Pharmaceuticals · Updated on 2026-03-11
822
Participants Needed
190
Research Sites
307 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of CD20-positive follicular lymphoma Grade 1-3a, stage II bulky or stage III/IV
- Need for treatment as described in the protocol
- Measurable disease seen on CT or MRI imaging
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Adequate bone marrow and liver function as described in the protocol
You will not qualify if you...
- Central nervous system lymphoma or leptomeningeal lymphoma
- Evidence of transformation to high-grade or diffuse large B-cell lymphoma
- Waldenström Macroglobulinemia, Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
- Prior treatment with any systemic anti-lymphoma therapy
- Infections or allergies/hypersensitivity to the study drug or its components as described in the protocol
- Other protocol-defined exclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 190 locations
1
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
Actively Recruiting
2
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
3
UC Irvine Health
Orange, California, United States, 92868
Withdrawn
4
Investigative Clinical Research of Indiana
Noblesville, Indiana, United States, 46062
Actively Recruiting
5
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
7
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
Completed
8
Icahn School of Medicine at Mt Sinai
New York, New York, United States, 10029
Actively Recruiting
9
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Actively Recruiting
10
Clinical Research Alliance Inc
Westbury, New York, United States, 11590
Withdrawn
11
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
12
Levine Cancer Institute
Charlotte, North Carolina, United States, 28207
Actively Recruiting
13
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
14
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
15
Center for Oncology and Blood Disorders
Houston, Texas, United States, 77030
Actively Recruiting
16
HOPE Cancer Center of East Texas
Tyler, Texas, United States, 75701
Withdrawn
17
Huntsman Cancer Institute - Oncology Division
Salt Lake City, Utah, United States, 84112
Actively Recruiting
18
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
19
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Withdrawn
20
Prohealth Care Inc
Waukesha, Wisconsin, United States, 53188
Withdrawn
21
Ingham Institute
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
22
Icon Cancer Centre - Wesley
Auchenflower, Queensland, Australia, 4066
Actively Recruiting
23
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Actively Recruiting
24
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
25
Epworth Freemasons
East Melbourne, Victoria, Australia, 3121
Actively Recruiting
26
St Vincent's Hospital - Melbourne
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
27
Alfred Hospital and Monash University
Melbourne, Victoria, Australia, 3004
Actively Recruiting
28
Ordensklinikum Linz
Linz, Osterreich, Austria, 4010
Actively Recruiting
29
Ordensklinikum Linz Gmbh, Elisabethinen
Linz, Austria, 4020
Actively Recruiting
30
Uniklinikum Salzburg (LKH) Universitatsklinik fur Innere Medizin III
Salzburg, Austria, 5020
Actively Recruiting
31
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
32
Hanusch Krankenhaus
Vienna, Austria, 1140
Actively Recruiting
33
AZ St.-Elisabeth Herentals vzw
Herentals, Antwerp, Belgium, 2200
Actively Recruiting
34
Hopital De Jolimont
La Louvière, Hainaut, Belgium, 7100
Withdrawn
35
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent, Oost-Vlaanderen, Belgium, 9000
Withdrawn
36
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, Belgium, 2060
Withdrawn
37
Institut Jules Bordet
Brussels, Belgium, 1000
Withdrawn
38
Ensino e Terapia de Inovacao Clinica Amo (Etica)
Salvador, Estado de Bahia, Brazil, 41950640
Actively Recruiting
39
Instituto Mario Pena de Ensino Pesquisa e Inovacao
Belo Horizonte, Minas Gerais, Brazil, 30380-420
Actively Recruiting
40
Liga Norte Riograndense Contra o Cancer
Natal, Rio Grande do Norte, Brazil, 59062-000
Actively Recruiting
41
Instituto do Cancer em Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil, 99010-080
Actively Recruiting
42
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035903
Actively Recruiting
43
Centro de Hematologia e Oncologia
Joinville, Santa Catarina, Brazil, 89201260
Actively Recruiting
44
Animi Unidade de Tratamento Oncologico Ltda
Lages, Santa Catarina, Brazil, 88501-001
Actively Recruiting
45
Fundacao Pio XII Hospital de Amor
Barretos, São Paulo, Brazil, 14784-400
Actively Recruiting
46
Amaral Carvalho Hospital
Jaú, São Paulo, Brazil, 17210080
Actively Recruiting
47
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirão Preto, São Paulo, Brazil, 14048-900
Actively Recruiting
48
Instituto DOr de Pesquisa e Ensino Df Star
Brasília, Brazil, 70390-140
Actively Recruiting
49
Instituto Nacional de Cancer Jose Alencar Gomes da Silva
Rio de Janeiro, Brazil, 20231050
Actively Recruiting
50
Instituto Americas
Rio de Janeiro, Brazil, 22793-334
Actively Recruiting
51
Hospital Alemao Oswaldo Cruz
São Paulo, Brazil, 01323-903
Actively Recruiting
52
AC Camargo Cancer Center
São Paulo, Brazil, 01509010
Actively Recruiting
53
Clinical Hospital of Medicine School at Sao Paulo University
São Paulo, Brazil, 05403-000
Actively Recruiting
54
Casa de Saude Santa Marcelina
São Paulo, Brazil, 08270-070
Actively Recruiting
55
Tom Baker Cancer Center
Calgary, Alberta, Canada, T2N 4J8
Actively Recruiting
56
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Actively Recruiting
57
Centre Integre de Sante et de Services Sociaux (CISSS) de la Monteregie-Centre
Greenfield Park, Quebec, Canada, J4V 2H1
Actively Recruiting
58
CHU de Quebec - Universite Laval
Québec, Quebec, Canada, G1J1Z4
Actively Recruiting
59
Ciusss de Lestrie - Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
60
Fundacion Arturo Lopez Perez
Santiago, Santiago Metropolitan, Chile, 7500921
Actively Recruiting
61
Centro Oncologia de Precision Universidad Mayor
Santiago, Santiago Metropolitan, Chile, 7560907
Withdrawn
62
Inmunocel
Santiago, Santiago Metropolitan, Chile, 7580206
Actively Recruiting
63
Clinica Alemana de Santiago
Santiago, Santiago Metropolitan, Chile, 7650620
Actively Recruiting
64
University Hospital Hradec Kralove
Hradec Králové, Czechia, 50005
Actively Recruiting
65
University Hospital Kralovske Vinohrady
Prague, Czechia, 10034
Actively Recruiting
66
Vseobecna Fakultni Nemocnice
Prague, Czechia, 12808
Actively Recruiting
67
Centre Hospitalier Universitaire (CHU) Rennes
Rennes, Brittany Region, France, 35033
Actively Recruiting
68
Centre Hospitalier Regional Universitaire de Tours
Tours, Centre-Val de Loire, France, 37044
Actively Recruiting
69
Nantes University Hospital
Nantes, Pays de la Loire Region, France, 44093
Actively Recruiting
70
Hopital de la Conception
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
Actively Recruiting
71
Centre Hospitalier Universitaire Angers
Angers, France, 49933
Actively Recruiting
72
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
73
Hopital Saint Louis
Paris, France, 75010
Actively Recruiting
74
Hopital Saint-Antoine
Paris, France, 755710
Actively Recruiting
75
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, France, 86021
Actively Recruiting
76
Institut de Cancerologie Strasbourg Europe (ICANS)
Strasbourg, France, 67033
Actively Recruiting
77
Hopital Victor Dupouy Argenteuil
Argenteuil, Île-de-France Region, France, 95100
Actively Recruiting
78
Gustave Roussy
Villejuif, Île-de-France Region, France, 94800
Actively Recruiting
79
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany, 70376
Withdrawn
80
University Hospital Wurzburg
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
81
Kliniken Ostalb Stauferklinikum Schwab Gmund
Mutlangen, Gmund, Germany, D-73557
Actively Recruiting
82
Clinic Frankfurt (Oder)
Frankfurt am Main, Hesse, Germany, 15236
Actively Recruiting
83
Universitatsmedizin der Johannes-Gutenberg Universitat Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
84
Hematological Praxis Dresden
Dresden, Saxony, Germany, 01307
Actively Recruiting
85
Charite Universitatsmedizin Berlin Campus Benjamin Franklin
Berlin, Germany, 12203
Actively Recruiting
86
University Hospital Carl Gustav Carus
Dresden, Germany, 01307
Actively Recruiting
87
Stadtisches Krankenhaus Kiel
Kiel, Germany, 24116
Actively Recruiting
88
Samson Assuta Ashdod University Hospital
Ashdod, Israel, 7747629
Actively Recruiting
89
Bnai Zion Medical Center
Haifa, Israel, 31048
Actively Recruiting
90
Hadassah Medical Center
Jerusalem, Israel, 91200
Actively Recruiting
91
Galilee Medical Center
Nahariya, Israel, 2210001
Actively Recruiting
92
Rabin Medical Center
Petah Tikva, Israel, 4941492
Actively Recruiting
93
Chaim Sheba Medical Center
Ramat Gan, Israel, 5265601
Actively Recruiting
94
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Actively Recruiting
95
Istituto Romagnolo Per Lo Studio Dei Tumori
Meldola, Forli Cesena, Italy, 47014
Actively Recruiting
96
Irccs Aou Di Bologna- Policlinico Di Sant'Orsola Malpighi
Bologna, Italia, Italy, 40138
Actively Recruiting
97
Pia Fondazione Panico
Tricase, Lecce, Italy, 73039
Actively Recruiting
98
IRCCS Ospedale Policlinico San Martino
Genoa, Liguria, Italy, 16132
Actively Recruiting
99
Candiolo Cancer Institute, FPO, IRCCS
Candiolo, Torino, Italy, 10060
Actively Recruiting
100
UOC Ematologia e Terapia Cellulare - PO Mazzoni AST Ascoli Piceno
Ascoli Piceno, Italy, 63100
Actively Recruiting
101
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
102
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
103
Federico II University
Naples, Italy, 80131
Actively Recruiting
104
AOU Maggiore della Carita-SCDU Ematologia
Novara, Italy, 28100
Actively Recruiting
105
UO Ematologia Ravenna
Ravenna, Italy, 48121
Actively Recruiting
106
Santa Maria della Misericordia
Udine, Italy, 33100
Actively Recruiting
107
Ospedale dell'Angelo - Varese
Varese, Italy, 21100
Actively Recruiting
108
Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu
Wałbrzych, Lower Silesian Voivodeship, Poland, 58-309
Actively Recruiting
109
Uniwersytecki Szpital Kliniczny
Wroclaw, Lower Silesian Voivodeship, Poland, 50-367
Actively Recruiting
110
Pratia MCM Krakow
Krakow, Malopolska, Poland, 30-510
Actively Recruiting
111
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland, 80-952
Actively Recruiting
112
Aidport
Skorzewo, Wielkopolska, Poland, 60185
Actively Recruiting
113
Cm Pratia Poznan
Skorzewo, Wielkopolska, Poland, 60185
Completed
114
Pratia Onkologia Katowice
Katowice, Poland, 40-519
Actively Recruiting
115
Copernicus Memorial Hospital
Lodz, Poland, 93-513
Withdrawn
116
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, Poland, 20-954
Actively Recruiting
117
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa
Warsaw, Poland, 02781
Withdrawn
118
Center for Hematologic Malignancy
Goyang-si, Gyeonggi-do, South Korea, 10408
Withdrawn
119
St. Vincents Hospital - The Catholic University of Korea
Suwon, Gyeonggi-do, South Korea, 16247
Actively Recruiting
120
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea, 16499
Actively Recruiting
121
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea, 54907
Withdrawn
122
Dong-A University Hospital
Busan, South Korea, 49201
Completed
123
Pusan National University Hospital
Busan, South Korea, 49241
Actively Recruiting
124
Kyungpook National University Chilgok Hospital
Daegu, South Korea, 41404
Withdrawn
125
Seoul St. Mary's Hospital
Seoul, South Korea, 06591
Withdrawn
126
University Hospital of Santiago de Compostela
Santiago de Compostela, A Coruna, Spain, 15706
Actively Recruiting
127
Hospital Universitario Virgen De La Victoria Malaga
Málaga, Andalusia, Spain, 29010
Actively Recruiting
128
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain, 41009
Actively Recruiting
129
Son Espases University Hospital
Palma, Balearic Islands, Spain, 07120
Withdrawn
130
Cruces University Hospital (Hospital Universitario Cruces)
Barakaldo, Bizkaia, Spain, 48903
Actively Recruiting
131
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
132
Complejo Hospitalario Universitario de a Coruna
A Coruña, Galicia, Spain, 15006
Withdrawn
133
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain, 28223
Actively Recruiting
134
Hospital Clinico Universitario Virgen De La Arrixaca
El Palmar, Murcia, Spain, 30120
Withdrawn
135
Hospital Universitario de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
136
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Withdrawn
137
University Hospital Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
138
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
139
Hospital Virgen De Las Nieves De Granada
Granada, Spain, 18014
Actively Recruiting
140
Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
141
Clinica Universidad de Navarra
Madrid, Spain, 28027
Withdrawn
142
Clinica Universidad de Navarra
Madrid, Spain, 28027
Actively Recruiting
143
Fundacion Jimenez Diaz University Hospital
Madrid, Spain, 28040
Actively Recruiting
144
University Hospital & Research Institute
Madrid, Spain, 28041
Actively Recruiting
145
Hospital Universitario HM Sanchinarro, Servicio de Hematologia
Madrid, Spain, 28050
Actively Recruiting
146
Morales Meseguer Hospital
Murcia, Spain, 30008
Actively Recruiting
147
Complexo Hospitalario Universitario de Ourense
Ourense, Spain, 32005
Actively Recruiting
148
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
149
University Hospital Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
150
Hospital Universitario Virgen de Valme
Seville, Spain, 41014
Actively Recruiting
151
Hospital General Universitario de Toledo
Toledo, Spain, 45007
Withdrawn
152
Hospital Clinico Universitario Valencia
Valencia, Spain, 46010
Actively Recruiting
153
Hospital Universitari and Politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
154
Hospital Clinico Lozano Blesa
Zaragoza, Spain, 50009
Actively Recruiting
155
Kantonsspital Baden
Baden, Canton of Aargau, Switzerland, 5404
Actively Recruiting
156
Cantonal Hospital St Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
Actively Recruiting
157
Kantonsspital Winterthur Medical Oncology
Winterthur, Schweiz, Switzerland, 8401
Actively Recruiting
158
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
159
Inselspital Bern University Hospital
Bern, Switzerland, 3010
Actively Recruiting
160
Chang Gung Medical Foundation Chia Yi Branch
Buzi, Chiayi County, Taiwan, 613
Withdrawn
161
Chang Gung Memorial Hospital Linkou
Taoyuan City, Guishan District, Taiwan, 333
Actively Recruiting
162
Changhua Christian Hospital
Changhua, Taiwan, 500-06
Actively Recruiting
163
Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
Actively Recruiting
164
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
Actively Recruiting
165
Taipei Medical University-Shuang Ho Hospital
New Taipei City, Taiwan, 235
Actively Recruiting
166
Taichung General Veterans Hospital
Taichung, Taiwan, 40705
Actively Recruiting
167
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
168
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
169
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
170
Tri-Service General Hospital
Taipei, Taiwan, 114
Actively Recruiting
171
Taipei Municipal Wan Fang Hospital
Taipei, Taiwan, 116
Actively Recruiting
172
Ankara University Faculty of Medicine
Mamak, Ankara, Turkey (Türkiye), 06620
Actively Recruiting
173
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Yenimahalle, Ankara, Turkey (Türkiye), 06200
Actively Recruiting
174
Gazi University
Ankara, Central Anatolia, Turkey (Türkiye), 06100
Actively Recruiting
175
VM Medical Park Mersin Hospital
Mezitli, Mersin, Turkey (Türkiye), 33200
Actively Recruiting
176
Tekirdag Namik Kemal University Hospital
Tekirdağ, Suleymanpasa, Turkey (Türkiye), 59100
Actively Recruiting
177
Liv Hospital Ankara
Ankara, Turkey (Türkiye), 06100
Actively Recruiting
178
VKV American Hopital
Istanbul, Turkey (Türkiye), 34365
Actively Recruiting
179
Istanbul University Istanbul Faculty of Medicine
Istanbul, Turkey (Türkiye), 34418
Actively Recruiting
180
Ege University
Izmir, Turkey (Türkiye), 35100
Actively Recruiting
181
Erci̇yes Uni̇versi̇ty
Kayseri, Turkey (Türkiye), 38039
Actively Recruiting
182
Sakarya University Medical Faculty
Sakarya, Turkey (Türkiye), 54290
Actively Recruiting
183
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, Turkey (Türkiye), 55239
Actively Recruiting
184
Zonguldak Bulent Ecevit University
Zonguldak, Turkey (Türkiye), 67100
Actively Recruiting
185
Royal Cornwall Hospitals NHS Trust
Truro, Cornwall, United Kingdom, TR1 3LJ
Actively Recruiting
186
Derriford Hospital and the Royal Eye Infirmary
Plymouth, Devon, United Kingdom, PL6 8DH
Withdrawn
187
University Hospitals Dorset
Bournemouth, Dorset, United Kingdom, BH77DW
Actively Recruiting
188
Beatson West of Scotland Cancer Centre
Glasgow, Lanarkshire, United Kingdom, G12 0YN
Actively Recruiting
189
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
Actively Recruiting
190
Barking, Havering and Redbridge University Hospitals NHS Trust
Romford, United Kingdom, RM7 0AG
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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