Actively Recruiting
A Phase 3, Open Label, Randomized Study Comparing Odronextamab Plus Lenalidomide Versus Rituximab Plus Lenalidomide in Adults With Relapsed or Refractory Follicular and Marginal Zone Lymphoma
Led by Regeneron Pharmaceuticals · Updated on 2026-05-06
470
Participants Needed
169
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an experimental drug called odronextamab combined with lenalidomide in adults who have relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL), which are subtypes of Non-Hodgkin's lymphoma. The study aims to assess the safety, tolerability, and proper dosing of this new combination and compare its effectiveness to the current standard treatment of rituximab combined with lenalidomide. The research also explores side effects, drug levels in the blood, immune responses to the drug, and impacts on quality of life and daily functioning. The study has two parts: Part 1 is a safety phase where all participants receive odronextamab plus lenalidomide to determine the appropriate dose. Part 2 is randomized and compares two groups—one receiving odronextamab with lenalidomide, and the other receiving rituximab with lenalidomide followed by lenalidomide alone. Participants receive these treatments according to the study protocol during these phases. Throughout the study, participants will undergo various assessments including safety monitoring for side effects, measurement of drug concentrations and immune responses, imaging scans to evaluate disease status, and quality-of-life questionnaires. The primary outcomes include tracking dose-limiting toxicities up to 35 days and treatment-emergent adverse events up to 2 years. Longer-term outcomes such as progression-free survival and overall survival will be followed for up to 5 years, with ongoing evaluations to understand the treatment's impact over time.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Confirmed diagnosis of follicular lymphoma grade 1-3a or marginal zone lymphoma (nodal, splenic, or extra nodal)
- Relapsed or refractory disease after at least one prior systemic treatment including an anti-CD20 monoclonal antibody
- Measurable disease on CT or MRI imaging
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate blood counts and organ function as defined by the study
- Understanding of lenalidomide's potential teratogenic risks and agreement to pregnancy precautions
- Agreement to abstain from blood donation during treatment and for 28 days after stopping lenalidomide
- Agreement not to share study medication with others
You will not qualify if you...
- Primary central nervous system lymphoma or CNS involvement by non-primary CNS lymphoma
- History or current diagnosis of high-grade or diffuse large B-cell lymphoma or other lymphoma histologies besides follicular lymphoma grade 1-3a or marginal zone lymphoma
- Current or past significant CNS conditions
- Other active cancers unless treated and cancer free for at least 3 years (with some exceptions like localized prostate cancer or certain skin cancers)
- Any other serious medical condition that could interfere with study participation or increase risk
- Allergy or hypersensitivity to study drugs or their ingredients
- Active infections as defined by the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive either odronextamab plus lenalidomide or rituximab plus lenalidomide as part of their treatment for relapsed or refractory follicular lymphoma or marginal zone lymphoma.
Regular visits as per treatment protocol
Duration - Up to 5 years
Participants are monitored for safety, treatment response, and long-term outcomes after treatment ends.
Periodic visits for assessments
Trial Site Locations
Total: 169 locations
1
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
2
Boca Raton Clinical Research (BRCR) Global
Plantation, Florida, United States, 33322
Actively Recruiting
3
Indiana University and Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
Actively Recruiting
5
Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
6
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Actively Recruiting
7
Clinical Research Alliance Inc
Westbury, New York, United States, 11590
Withdrawn
8
Prohealth Care Inc
Waukesha, Wisconsin, United States, 53188
Actively Recruiting
9
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
10
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Actively Recruiting
11
Pindara Private Hospital
Benowa, Queensland, Australia, 4217
Actively Recruiting
12
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Actively Recruiting
13
Epworth Freemasons
East Melbourne, Victoria, Australia, 3121
Actively Recruiting
14
Ordensklinikum Linz
Linz, Osterreich, Austria, 4020
Actively Recruiting
15
Kepler University Hospital
Linz, Upper Austria, Austria, 4020
Actively Recruiting
16
Medical University Vienna
Vienna, Austria, 1090
Actively Recruiting
17
Klinikum Wels-Grieskirchen
Wels, Austria, 4600
Actively Recruiting
18
Centre Hospitalier Universitaire at Universite Catholique de Louvain Namur
Yvoir, Namur, Belgium, 5530
Actively Recruiting
19
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
20
Algemeen Ziekenhuis AZ Delta
Roeselare, West-Vlaanderen, Belgium, 8800
Actively Recruiting
21
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, Belgium, 2060
Actively Recruiting
22
Institut Jules Bordet
Brussels, Belgium, 1000
Actively Recruiting
23
Hospital Sao Rafael
Salvador, Estado de Bahia, Brazil, 40285-000
Actively Recruiting
24
Hospital Sirio Libanes Brasilia
Brasília, Federal District, Brazil, 70200-730
Actively Recruiting
25
Uopeccan Hospital do Cancer de Cascavel
Cascavel, Paraná, Brazil, 85806-300
Actively Recruiting
26
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil, 81520-060
Actively Recruiting
27
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Actively Recruiting
28
Centro Gaucho Integrado
Porto Alegre, Rio Grande do Sul, Brazil, 90110-270
Actively Recruiting
29
Amaral Carvalho Hospital
Jaú, São Paulo, Brazil, 17210-080
Actively Recruiting
30
Instituto Nacional de Cancer Jose Alencar Gomes da Silva
Rio de Janeiro, Brazil, 20231050
Actively Recruiting
31
Hospital Sirio Libanes
São Paulo, Brazil, 01308-050
Actively Recruiting
32
A Beneficencia Portuguesa de Sao Paulo, Oncology House
São Paulo, Brazil, 01321000
Actively Recruiting
33
University Hospital Hradec Kralove
Hradec Králové, East Bohemia, Czechia, 50005
Actively Recruiting
34
Fakultni Nemocnice Brno
Brno, Czechia, 62500
Actively Recruiting
35
University Hospital Kralovske Vinohrady
Prague, Czechia, 10034
Actively Recruiting
36
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia, 12808
Actively Recruiting
37
Institut Paoli-Calmettes
Marseille, Bouches Du Rhone, France, 13009
Actively Recruiting
38
CHU de Rennes
Rennes, Brittany Region, France, 35033
Actively Recruiting
39
Centre Hospitalier Regional Universitaire de Tours
Tours, Centre-Val de Loire, France, 37044
Actively Recruiting
40
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, Gironde, France, 33077
Actively Recruiting
41
Centre Francois Magendie
Pessac, Gironde, France, 33600
Actively Recruiting
42
Hopital Saint Vincent-de-Paul
Lille, Nord, France, 5900
Actively Recruiting
43
Centre Henri Becquerel
Rouen, Normandy, France, 76038
Actively Recruiting
44
Nantes University Hospital
Nantes, Pays de la Loire Region, France, 44093
Actively Recruiting
45
Centre Hospitalier Metropole Savoie
Chambéry, Savoie, France, 73000
Actively Recruiting
46
Centre Hospitalier d'Avignon
Avignon, France, 84000
Actively Recruiting
47
Centre Hospitalier Universitaire (CHU) Montpellier
Montpellier, France, 34290
Actively Recruiting
48
Hopital Saint Louis
Paris, France, 75010
Actively Recruiting
49
Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, France, 75571
Actively Recruiting
50
Institut Curie
Saint-Cloud, France, 92210
Actively Recruiting
51
Hopital Victor Dupouy Argenteuil
Argenteuil, Île-de-France Region, France, 95100
Actively Recruiting
52
Avicenne Hospital
Bobigny, Île-de-France Region, France, 93000
Actively Recruiting
53
Gustave Roussy
Villejuif, Île-de-France Region, France, 94800
Actively Recruiting
54
Stauferklinikum
Mutlangen, Baden-Wurttemberg, Germany, 73557
Actively Recruiting
55
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany, 70376
Actively Recruiting
56
LMU Klinikum
Munich, Bavaria, Germany, 80337
Actively Recruiting
57
TUM Fakultat fur Medizin - Klinikum Rechts der Isar
Munich, Bavaria, Germany, 81675
Actively Recruiting
58
Clinic Frankfurt (Oder)
Frankfurt am Main, Hesse, Germany, 15236
Actively Recruiting
59
Universitatsmedizin der Johannes-Gutenberg Universitat Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
60
University Hospital Halle Saale
Halle, Germany, 6120
Actively Recruiting
61
Stadtisches Krankenhaus Kiel
Kiel, Germany, 24116
Actively Recruiting
62
MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
Neuss, Germany, 41462
Actively Recruiting
63
Assuta Ashdod Medical Center
Ashdod, Israel, 7747629
Actively Recruiting
64
Hadassah Medical Center
Jerusalem, Israel, 91200
Actively Recruiting
65
Galilee Medical Center
Nahariya, Israel, 2210001
Actively Recruiting
66
Rabin Medical Center
Petah Tikva, Israel, 49100
Actively Recruiting
67
Chaim Sheba Medical Center
Ramat Gan, Israel, 5265601
Actively Recruiting
68
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Actively Recruiting
69
Assuta Medical Centers
Tel Aviv, Israel, 6971028
Actively Recruiting
70
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Forli-Cesena, Italy, 47014
Actively Recruiting
71
Ospedale Policlinico San Martino IRCCS
Genoa, Genova, Italy, 16132
Actively Recruiting
72
S Gerardo Hospital
Monza, Monza E Brianza, Italy, 20900
Actively Recruiting
73
A.O.U. Citta della Salute e della Scienza di Torino
Turin, Piedmont, Italy, 10126
Actively Recruiting
74
Centro Di Riferimento Oncologico (CRO), Aviano, National Cancer Institute
Aviano, Pordenone, Italy, 33081
Actively Recruiting
75
Candiolo Cancer Institute, FPO, IRCCS
Candiolo, Torino, Italy, 10060
Actively Recruiting
76
University of Bologna Dipartimento di Medicina Specialistica Diagnostica e Sperimentale
Bologna, Italy, 40138
Actively Recruiting
77
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
78
ASST Grande Ospedale Metropolitano Niguarda - Main Address
Milan, Italy, 20162
Actively Recruiting
79
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
80
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
81
A.O.U. di Modena
Modena, Italy, 41124
Actively Recruiting
82
Federico II University
Naples, Italy, 80131
Actively Recruiting
83
AOU Maggiore della Carita
Novara, Italy, 28100
Actively Recruiting
84
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Actively Recruiting
85
Azienda Ospedaliera di Perugia
Perugia, Italy, 06132
Actively Recruiting
86
Ospedale Santa Maria delle Croci
Ravenna, Italy, 48121
Actively Recruiting
87
Santa Maria della Misericordia
Udine, Italy, 33100
Actively Recruiting
88
Hospital Sultanah Aminah Jhor Bahru
Johor Bahru, Johor, Malaysia, 80100
Actively Recruiting
89
University of Malaya Medical Centre
Kuala Lumpur, Negeri / Wilayah Persekutuan, Malaysia, 50603
Actively Recruiting
90
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, Malaysia, 88586
Actively Recruiting
91
Hospital Ampang
Ampang, Selangor, Malaysia, 68000
Actively Recruiting
92
Subang Jaya Medical Center
Subang Jaya, Selangor, Malaysia, 47500
Actively Recruiting
93
Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu
Wałbrzych, Lower Silesian Voivodeship, Poland, 58-309
Actively Recruiting
94
Uniwersytecki Szpital Kliniczny
Wroclaw, Lower Silesian Voivodeship, Poland, 50-367
Actively Recruiting
95
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie, Centrum Innowacyjnych Terapii
Lublin, Lublin Voivodeship, Poland, 20-090
Actively Recruiting
96
Pratia MCM Krakow
Krakow, Malopolska, Poland, 30-510
Actively Recruiting
97
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland, 80-952
Actively Recruiting
98
Pratia Poznan Medical Center
Poznan, Wielkopolska, Poland, 60185
Completed
99
Aidport
Skorzewo, Wielkopolska, Poland, 60185
Actively Recruiting
100
Szpital Uniwersytecki Nr2 Bydgoszcz
Bydgoszcz, Poland, 85-168
Withdrawn
101
Pratia Onkologia Katowice
Katowice, Poland, 40-519
Actively Recruiting
102
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)
Lodz, Poland, 93-513
Actively Recruiting
103
Narodowy Instytut Onkologii
Warsaw, Poland, 02-781
Actively Recruiting
104
St. Vincents Hospital - The Catholic University of Korea
Suwon, Gyeonggi-do, South Korea, 16247
Actively Recruiting
105
Jeonbuk National University Hospital
Jeonju, Jeollabuk, South Korea, 54907
Actively Recruiting
106
Gachon University Gil Medical Center
Incheon, Namdong-Gu, South Korea, 21565
Actively Recruiting
107
Inje University Busan Paik Hospital
Busan, South Korea, 47392
Actively Recruiting
108
Pusan National University Hospital
Busan, South Korea, 49241
Actively Recruiting
109
Yeyungnam University Medical Center
Daegu, South Korea, 42415
Withdrawn
110
Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
111
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
112
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
113
Yeouido St. Marys Hospital
Seoul, South Korea, 07345
Actively Recruiting
114
Seoul St Marys Hospital
Seoul, South Korea, 137-701
Actively Recruiting
115
Seoul National University Hospital
Seoul, South Korea, 3080
Actively Recruiting
116
Ulsan University Hospital
Ulsan, South Korea, 44033
Actively Recruiting
117
University Hospital of Santiago de Compostela
Santiago de Compostela, A Coruna, Spain, 15706
Actively Recruiting
118
Son Espases University Hospital
Palma, Balearic Islands, Spain, 07120
Actively Recruiting
119
Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
120
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
121
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain, 28223
Actively Recruiting
122
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
123
University Hospital Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
124
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Actively Recruiting
125
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
126
Hospital Virgen De Las Nieves De Granada
Granada, Spain, 18014
Actively Recruiting
127
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
128
Fundacion Jimenez Diaz University Hospital
Madrid, Spain, 28040
Actively Recruiting
129
Hospital Universitario12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
130
Hospital Universitario HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
131
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
132
University Hospital Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
133
Instituto Valenciano de Oncologia
Valencia, Spain, 46009
Actively Recruiting
134
University Hospital Doctor Peset
Valencia, Spain, 46017
Actively Recruiting
135
Chang Gung Medical Foundation Chia Yi Branch
Buzi, Chiayi County, Taiwan, 613
Actively Recruiting
136
Changhua Christian Hospital
Changhua, Taiwan, 500-06
Actively Recruiting
137
Show Chwan Memorial Hospital
Changhua, Taiwan, 50008
Actively Recruiting
138
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan, 80756
Actively Recruiting
139
Chang Gung Memorial Hospital Kaohsiung
Kaohsiung City, Taiwan, 83301
Actively Recruiting
140
Taipei Medical University - Shuang Ho Hospital
New Taipei City, Taiwan, 23561
Actively Recruiting
141
National Cheng Kung University Hospital
Tainan, Taiwan, 701
Actively Recruiting
142
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
143
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
144
Tri-Service General Hospital
Taipei, Taiwan, 11490
Actively Recruiting
145
Taipei Municipal Wan Fang Hospital
Taipei, Taiwan, 116
Actively Recruiting
146
Chang Gung Memorial Hospital
Taoyuan City, Taiwan, 333
Actively Recruiting
147
Chulalongkorn University
Bangkok, Krung Thep Maha Nakhon [Bangko], Thailand, 10330
Actively Recruiting
148
Sriraj Hospital
Bangkok, Thailand, 10700
Actively Recruiting
149
Chiang Mai University
Chiang Mai, Thailand, 50200
Actively Recruiting
150
Ankara University Faculty of Medicine
Mamak, Ankara, Turkey (Türkiye), 06620
Actively Recruiting
151
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Yenimahalle, Ankara, Turkey (Türkiye), 06200
Actively Recruiting
152
Gazi University
Ankara, Central Anatolia, Turkey (Türkiye), 06100
Actively Recruiting
153
VM Medical Park Mersin Hospital
Mezitli, Mersin, Turkey (Türkiye), 33200
Actively Recruiting
154
Tekirdag Namik Kemal University Hospital
Tekirdağ, Suleymanpasa, Turkey (Türkiye), 59100
Actively Recruiting
155
Istanbul University, Istanbul Medical Faculty
Istanbul, Turkey (Türkiye), 34093
Actively Recruiting
156
Ege University
Izmir, Turkey (Türkiye), 35100
Actively Recruiting
157
Dokuz Eylul University
Izmir, Turkey (Türkiye), 35340
Actively Recruiting
158
Sakarya University Medical Faculty
Sakarya, Turkey (Türkiye), 54290
Actively Recruiting
159
Ondokuz Mayıs University
Samsun, Turkey (Türkiye), 55270
Actively Recruiting
160
Zonguldak Bulent Ecevit University
Zonguldak, Turkey (Türkiye), 67600
Actively Recruiting
161
Royal Cornwall Hospitals NHS Trust
Truro, Cornwall, United Kingdom, TR1 3LJ
Actively Recruiting
162
Derriford Hospital and the Royal Eye Infirmary
Plymouth, Devon, United Kingdom, PL6 8DH
Actively Recruiting
163
University Hospitals Dorset
Bournemouth, Dorset, United Kingdom, BH7 7DW
Actively Recruiting
164
Salisbury Foundation Trust
Salisbury, Hampshire, United Kingdom, SP6 2ND
Actively Recruiting
165
The Hillingdon Hospital
Uxbridge, Middlesex, United Kingdom, UB8 3NN
Actively Recruiting
166
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
167
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, United Kingdom, NR31 6LA
Actively Recruiting
168
Barking, Havering and Redbridge University Hospitals NHS Trust
Romford, United Kingdom, RM7 0AG
Actively Recruiting
169
South Warwickshire NHS Foundation Trust
Warwick, United Kingdom, CV34 5BW
Actively Recruiting
Research Team
C
Clinical Trials Administrator
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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