Actively Recruiting
A Phase 3 Study Comparing Odronextamab Plus CHOP Versus Rituximab Plus CHOP in Adults with Previously Untreated Diffuse Large B-cell Lymphoma
Led by Regeneron Pharmaceuticals · Updated on 2026-05-15
904
Participants Needed
155
Research Sites
75 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying an experimental drug called odronextamab, combined with chemotherapy, in adults with Diffuse Large B-cell Lymphoma (DLBCL). The study includes patients who have not been treated before, as well as those whose lymphoma has returned or not responded to prior treatment. The goal is to evaluate the safety, dosing, and effectiveness of odronextamab combined with chemotherapy compared to the current standard treatment of rituximab plus chemotherapy. The study consists of three parts: Part 1A involves dose escalation to find safe levels of odronextamab; Part 1B explores two dosing schedules of odronextamab with chemotherapy; and Part 2 compares the combination of odronextamab with chemotherapy against rituximab with chemotherapy. Odronextamab and rituximab are given by intravenous infusion, while chemotherapy drugs cyclophosphamide, doxorubicin, and vincristine are given intravenously and prednisone or prednisolone is taken orally. Participants will have regular evaluations including safety monitoring, blood tests to measure drug levels and antibodies, and assessments of quality of life and physical functioning. The study will track side effects, response to treatment, survival, and disease progression over several years. The total study duration can be up to five years, with ongoing assessments to understand the long-term impact of the treatments.
CONDITIONS
Brief Title
A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of previously untreated CD20-positive Diffuse Large B-cell Lymphoma or relapsed/refractory DLBCL (Part 1A only)
- Measurable disease with at least one nodal or extranodal lesion
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Life expectancy of at least 12 months
- International Prognostic Index (IPI) of 3 to 5 (Part 1) and 2 or more (Part 2) for untreated DLBCL
- Adequate blood cell counts and organ function as defined in the protocol
You will not qualify if you...
- Primary central nervous system lymphoma or known involvement by non-primary CNS non-Hodgkin lymphoma
- Another active cancer or significant medical condition
- Peripheral neuropathy of Grade 3 or higher
- Prior systemic anti-lymphoma therapy except for relapsed/refractory DLBCL or transformed lymphoma after prior treatment
- Use of other therapies or investigational treatments within 28 days or 5 half-lives before study treatment
- Recent major surgery, prior organ transplant, or standard radiotherapy
- Allergy or hypersensitivity to study drugs
- Active infections including COVID-19, uncontrolled HIV, hepatitis B or C, or cytomegalovirus infection
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 22 weeks
Participants receive either Odronextamab combined with CHOP chemotherapy or Rituximab combined with CHOP chemotherapy. Treatment involves intravenous and oral medications administered as part of chemotherapy cycles.
Multiple visits during treatment cycles
Duration - Up to 5 years
Participants are monitored for safety, treatment outcomes, and quality of life after completing treatment. This includes assessments of progression-free survival, overall survival, and patient-reported outcomes.
Regular visits over several years for assessments
Trial Site Locations
Total: 155 locations
1
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of California Irvine Medical Center
Orange, California, United States, 92868
Actively Recruiting
3
University of California (UC) Davis
Sacramento, California, United States, 95817
Actively Recruiting
4
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
St Vincent Ascension at Peyton Manning Childrens Hospital
Indianapolis, Indiana, United States, 46260
Actively Recruiting
6
Investigative Clinical Research of Indiana
Noblesville, Indiana, United States, 46062
Actively Recruiting
7
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
8
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
9
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
11
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
12
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
13
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Actively Recruiting
14
Clinical Research Alliance Inc
Westbury, New York, United States, 11590
Withdrawn
15
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
16
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
17
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
18
Center for Oncology and Blood Disorders
Houston, Texas, United States, 77030
Withdrawn
19
Community Cancer Trials of Utah
Ogden, Utah, United States, 84405
Actively Recruiting
20
Prohealth Care Inc
Waukesha, Wisconsin, United States, 53188
Withdrawn
21
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
22
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Actively Recruiting
23
Icon Cancer Centre - Wesley
Auchenflower, Queensland, Australia, 4066
Actively Recruiting
24
Pindara Private Hospital
Benowa, Queensland, Australia, 4217
Actively Recruiting
25
Epworth Freemasons
East Melbourne, Victoria, Australia, 3121
Actively Recruiting
26
Landeskrankenhaus Hochsteiermark
Leoben, Styria, Austria, 8700
Actively Recruiting
27
Kepler University Hospital
Linz, Upper Austria, Austria, 4020
Actively Recruiting
28
Medical University Graz
Graz, Austria, 8036
Actively Recruiting
29
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
30
Hanusch Krankenhaus
Vienna, Austria, 1140
Actively Recruiting
31
Klinikum Wels-Grieskirchen
Wels, Austria, 4600
Actively Recruiting
32
AZ St.-Elisabeth Herentals vzw
Herentals, Antwerp, Belgium, 2200
Actively Recruiting
33
Centre Hospitalier Regional de Verviers
Verviers, Liege, Belgium, 4800
Actively Recruiting
34
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
35
Az Delta
Roeselare, West-Vlaanderen, Belgium, 8800
Actively Recruiting
36
Institut Jules Bordet
Brussels, Belgium, 1000
Actively Recruiting
37
Hospital Clinico Universidad de Los Andes
Santiago, Las Condes, Chile, 7620157
Actively Recruiting
38
Centro Oncologia de Precision Universidad Mayor
Santiago, Santiago Metropolitan, Chile, 7560907
Actively Recruiting
39
Inmunocel
Santiago, Santiago Metropolitan, Chile, 7580206
Actively Recruiting
40
Clinica Alemana de Santiago
Santiago, Chile, 7650568
Actively Recruiting
41
University Hospital Hradec Kralove
Hradec Králové, East Bohemia, Czechia, 50005
Actively Recruiting
42
University Hospital Kralovske Vinohrady
Prague, Czechia, 10034
Actively Recruiting
43
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia, 12808
Actively Recruiting
44
Centre Hospitalier Universitaire (CHU) Rennes
Rennes, Brittany Region, France, 35033
Actively Recruiting
45
CHRU de Tours
Tours, Centre-Val de Loire, France, 37044
Actively Recruiting
46
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, Gironde, France, 33077
Actively Recruiting
47
Centre Hospitalier Universitaire (CHU) de Bordeaux
Pessac, New Aquitaine, France, 33600
Actively Recruiting
48
Centre Hospitalier Universitaire De Poitiers
Poitiers, New Aquitaine, France, 86000
Actively Recruiting
49
Hopital Saint Vincent-de-Paul
Lille, Nord, France, 5900
Actively Recruiting
50
Nantes University Hospital
Nantes, Pays de la Loire Region, France, 44093
Actively Recruiting
51
Centre Hospitalier Metropole Savoie
Chambéry, Savoie, France, 73000
Actively Recruiting
52
Centre Hospitalier Universitaire Angers
Angers, France, 49000
Actively Recruiting
53
Change Annecy
Metz-Tessy, France, 74374
Actively Recruiting
54
CHU Nimes Institut de Cancerologie
Nîmes, France, 30029
Actively Recruiting
55
Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, France, 75571
Actively Recruiting
56
CHU de Saint-Etienne
Saint-Etienne, France, 42055
Actively Recruiting
57
Hopital Victor Dupouy Argenteuil
Argenteuil, Île-de-France Region, France, 95100
Actively Recruiting
58
Avicenne Hospital
Bobigny, Île-de-France Region, France, 93000
Actively Recruiting
59
Gustave Roussy
Villejuif, Île-de-France Region, France, 94800
Actively Recruiting
60
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg, Germany, 70376
Actively Recruiting
61
Kliniken Ostalb Stauferklinikum Schwab Gmund
Mutlangen, Gmund, Germany, D-73557
Actively Recruiting
62
Clinic Frankfurt (Oder)
Frankfurt am Main, Hesse, Germany, 15236
Actively Recruiting
63
University Hospital Essen
Essen, North Rhine-Westphalia, Germany, 45122
Actively Recruiting
64
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
65
Hematological Praxis Dresden
Dresden, Saxony, Germany, 01307
Actively Recruiting
66
University Hospital Carl Gustav Carus
Dresden, Germany, 01307
Actively Recruiting
67
Stadtisches Krankenhaus Kiel
Kiel, Germany, 24116
Actively Recruiting
68
Beaumont Hospital
Dublin, Leinster, Ireland, D09V2N0
Withdrawn
69
St James Hospital and Trinity College Dublin
Dublin, Ireland, D08
Actively Recruiting
70
The Chaim Sheba Medical Center
Tel Litwinsky, Tel Aviv, Israel, 5265601
Actively Recruiting
71
Samson Assuta Ashdod University Hospital
Ashdod, Israel, 7747629
Actively Recruiting
72
Bnai Zion Medical Center
Haifa, Israel, 31048
Actively Recruiting
73
Hadassah Medical Center
Jerusalem, Israel, 91200
Actively Recruiting
74
Galilee Medical Center
Nahariya, Israel, 2210001
Actively Recruiting
75
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Actively Recruiting
76
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Forli-Cesena, Italy, 47014
Actively Recruiting
77
ASST Monza Ospedale San Gerardo
Monza, Monza E Brianza, Italy, 20900
Actively Recruiting
78
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
79
A.O.U. di Modena
Modena, Italy, 41124
Actively Recruiting
80
Federico II University
Naples, Italy, 80131
Actively Recruiting
81
AOU Maggiore della Carita
Novara, Italy, 28100
Actively Recruiting
82
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Actively Recruiting
83
Azienda Ospedaliera di Perugia
Perugia, Italy, 06132
Actively Recruiting
84
Ospedale Santa Maria delle Croci
Ravenna, Italy, 48121
Actively Recruiting
85
Hematology - Città della Salute e della Scienza di Torino
Turin, Italy, 10126
Actively Recruiting
86
Santa Maria della Misericordia
Udine, Italy, 33100
Actively Recruiting
87
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
Actively Recruiting
88
Hospital Tg Ampuan Afzan
Kuantan, Pahang, Malaysia, 25200
Actively Recruiting
89
Hospital Queen Elizabeth
Kota Kinabalu, Sabah, Malaysia, 88200
Actively Recruiting
90
Hospital Ampang
Ampang, Selangor, Malaysia, 68000
Actively Recruiting
91
Subang Jaya Medical Center
Subang Jaya, Selangor, Malaysia, 47500
Actively Recruiting
92
Matopolskie Centrum Medyczne S.C.
Krakow, Lesser Poland Voivodeship, Poland, 30-510
Actively Recruiting
93
Uniwersytecki Szpital Kliniczny
Wroclaw, Lower Silesian Voivodeship, Poland, 50-367
Actively Recruiting
94
Pratia Poznan Medical Center
Poznan, Wielkopolska, Poland, 60185
Withdrawn
95
Aidport
Skorzewo, Wielkopolska, Poland, 60185
Actively Recruiting
96
Szpital Uniwersytecki Nr2 Bydgoszcz
Bydgoszcz, Poland, 85-168
Withdrawn
97
Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center
Gdansk, Poland, 80-952
Actively Recruiting
98
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, Poland, 20-954
Actively Recruiting
99
Szpital Szpecjalistyczny w Walbrzychu
Wałbrzych, Poland, 58-300
Actively Recruiting
100
Wielospecjalistyczne Centrum Onkologii i Traumatologii
Lodz, Łódź Voivodeship, Poland, 93-510
Actively Recruiting
101
National University Hospital Singapore
Singapore, Singapore, 119074
Actively Recruiting
102
National Cancer Centre of Singapore
Singapore, Singapore, 168583
Actively Recruiting
103
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Actively Recruiting
104
St. Vincent Hospital - The Catholic University of Korea
Suwon, Gyeonggi-do, South Korea, 16247
Actively Recruiting
105
Gachon University Gil Medical Center
Incheon, Namdong-Gu, South Korea, 21565
Actively Recruiting
106
Inje University Busan Paik Hospital
Busan, South Korea, 47392
Actively Recruiting
107
Dong-A University Hospital
Busan, South Korea, 49201
Actively Recruiting
108
Pusan National University Hospital
Busan, South Korea, 49241
Actively Recruiting
109
Yeyungnam University Medical Center
Daegu, South Korea, 42415
Actively Recruiting
110
Keimyung University Dongsan Hospital
Daegu, South Korea, 42601
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
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna, Spain, 15706
Actively Recruiting
116
Hospital Universitario Virgen del Rocio
Seville, Andalusia, Spain, 41013
Actively Recruiting
117
Son Espases University Hospital
Palma, Balearic Islands, Spain, 07120
Actively Recruiting
118
Hospital Universitari Parc Tauli
Sabadell, Barcelona, Spain, 08208
Actively Recruiting
119
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona, Spain, 08221
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 de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
123
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
124
Hospital Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
125
Hospital Virgen De Las Nieves De Granada
Granada, Spain, 18014
Actively Recruiting
126
Hospital Universitario Infanta Leonor
Madrid, Spain, 28031
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 Universitario HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
130
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
131
Hospital General Universitario de Toledo
Toledo, Spain, 45007
Withdrawn
132
Instituto Valenciano de Oncologia
Valencia, Spain, 46009
Actively Recruiting
133
University Hospital Doctor Peset
Valencia, Spain, 46017
Actively Recruiting
134
Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, Spain, 46026
Actively Recruiting
135
Chang Gung Medical Foundation Chia Yi Branch
Buzi, Chiayi County, Taiwan, 613
Actively Recruiting
136
Chang Gung Memorial Hospital - Linkou Branch
Taoyuan, Hunan Province, Taiwan, 33305
Actively Recruiting
137
Changhua Christian Hospital
Changhua, Taiwan, 50006
Actively Recruiting
138
Taipei Medical University - Shuang Ho Hospital
New Taipei City, Taiwan, 23561
Actively Recruiting
139
Wanfang Hospital
Taipei, Taiwan, 00116
Actively Recruiting
140
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
141
Chulalongkorn University
Bangkok, Krung Thep Maha Nakhon [Bangko], Thailand, 10330
Actively Recruiting
142
Sriraj Hospital
Bangkok, Thailand, 10700
Actively Recruiting
143
Chaing Mai University
Chiang Mai, Thailand, 50200
Actively Recruiting
144
Faculty of Medicine
Khon Kaen, Thailand, 40002
Actively Recruiting
145
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Yenimahalle, Ankara, Turkey (Türkiye), 06200
Actively Recruiting
146
VM Medical Park Mersin Hospital
Mezitli, Mersin, Turkey (Türkiye), 33200
Actively Recruiting
147
Tekirdag Namik Kemal University Hospital
Tekirdağ, Suleymanpasa, Turkey (Türkiye), 59100
Actively Recruiting
148
Gazi Universitesi
Beşevler, Turkey (Türkiye), 6500
Actively Recruiting
149
Istanbul University Istanbul Faculty of Medicine
Istanbul, Turkey (Türkiye), 34418
Actively Recruiting
150
Ege University
Izmir, Turkey (Türkiye), 35100
Actively Recruiting
151
Dokuz Eylul University
Izmir, Turkey (Türkiye), 35340
Actively Recruiting
152
Sakarya University Medical Faculty
Sakarya, Turkey (Türkiye), 54290
Actively Recruiting
153
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, Turkey (Türkiye), 55239
Actively Recruiting
154
NHS Grampian: Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Actively Recruiting
155
The Hillingdon Hospitals NHS Foundation Trust
Uxbridge, United Kingdom, UB8 3NN
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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