Phase
Condition
Lymphoma, B-cell
Lymphoma
Treatment
Prednisone/Prednisolone
Doxorubicin
Odronextamab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
KEY Inclusion Criteria:
Previously untreated participants for lymphoma with documented cluster ofdifferentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed orrefractory DLBCL, for whom next available standard of care therapy is not availableor deemed ineligible according to the investigator (Part 1A only)
Measurable disease with at least one nodal lesion or at least one extranodal lesion,as described in the protocol
Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Life expectancy ≥ 12 months
International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) foruntreated DLBCL only;
Adequate hematologic and organ function, as defined in the protocol.
Exclusion
KEY Exclusion Criteria:
Primary central nervous system (CNS) lymphoma or known involvement by non-primaryCNS NHL and history or current relevant CNS pathology
Another active malignancy, significant active disease or medical condition, asdescribed in the protocol
Peripheral neuropathy Grade ≥3
Treatment with any systemic anti-lymphoma therapy, except for participants withrelapsed/refractory (R/R) DLBCL and participants with DLBCL transformed from anindolent follicular lymphoma after treatment with systemic anti-lymphoma therapy.
Any other therapy or investigational treatment within 28 days or 5 half-lives of thedrug, whichever is shorter, prior to the start of study treatment
Recent major surgery, prior organ transplantation, or standard radiotherapy, asdescribed in the protocol
Allergy/hypersensitivity to study drugs, as described in the protocol
Infections such as any active infection (bacterial, viral, fungal, mycobacterial,parasitic or other), active Coronavirus disease (COVID-19) infection, uncontrolledinfection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), orhepatitis C virus (HCV), Cytomegalovirus (CMV) infection, as described in theprotocol.
Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Study Design
Connect with a study center
Liverpool Hospital
Liverpool, New South Wales 2170
AustraliaActive - Recruiting
Calvary Mater Newcastle
Waratah, New South Wales 2298
AustraliaActive - Recruiting
Icon Cancer Centre
Auchenflower, Queensland 4066
AustraliaActive - Recruiting
Icon Cancer Centre - Wesley
Auchenflower, Queensland 4066
AustraliaActive - Recruiting
Pindara Private Hospital
Benowa, Queensland 4217
AustraliaActive - Recruiting
Epworth Freemasons
East Melbourne, Victoria 3121
AustraliaActive - Recruiting
Landeskrankenhaus Hochsteiermark
Leoben, Styria 8700
AustriaActive - Recruiting
Kepler University Hospital
Linz, Upper Austria 4020
AustriaActive - Recruiting
Medical University Graz
Graz, 8036
AustriaActive - Recruiting
Hanusch Krankenhaus
Vienna, 1140
AustriaActive - Recruiting
Medical University of Vienna
Vienna, 1090
AustriaActive - Recruiting
Klinikum Wels Grieskirchen
Wels, 4600
AustriaActive - Recruiting
Klinikum Wels-Grieskirchen
Wels, 4600
AustriaActive - Recruiting
Klinikum Wels-Grieskirchen GmbH
Wels, 4600
AustriaActive - Recruiting
AZ St.-Elisabeth Herentals vzw
Herentals, Antwerp 2200
BelgiumActive - Recruiting
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Gent, Oost-Vlaanderen 9000
BelgiumActive - Recruiting
AZ Delta
Roeselare, West Flanders 8800
BelgiumActive - Recruiting
Az Delta
Roeselare, West Vlaanderen 8800
BelgiumActive - Recruiting
Institut Jules Bordet
Brussels, 1000
BelgiumActive - Recruiting
Az st Elizabeth
Herentals, 2200
BelgiumActive - Recruiting
CHR de Verviers
Verviers, 4800
BelgiumActive - Recruiting
Centre Hospitalier Regional de Verviers
Verviers, 4800
BelgiumActive - Recruiting
Hospital Clinico Universidad de Los Andes
Santiago, Las Condes 7620157
ChileActive - Recruiting
Inmunocel
Santiago, Region Metropolitana 7580206
ChileActive - Recruiting
Clinica Alemana de Santiago
Santiago, 7650568
ChileActive - Recruiting
University Hospital Hradec Kralove
Hradec Kralove, East Bohemia 50005
CzechiaActive - Recruiting
University Hospital Hradec Kralove
Hradec Kralove 5, 50005
CzechiaSite Not Available
University Hospital Kralovske Vinohrady
Prague, 10034
CzechiaActive - Recruiting
Vseobecna Fakultni Nemocnice V Praze
Praha, 12808
CzechiaActive - Recruiting
Centre Hospitalier Universitaire (CHU) Rennes
Rennes, Bretagne 35033
FranceActive - Recruiting
CHRU de Tours
Tours, Centre Val De Loire 37044
FranceActive - Recruiting
Polyclinique Bordeaux Nord Aquitaine
Bordeaux Cedex, Gironde 33077
FranceActive - Recruiting
Hopital Victor Dupouy Argenteuil
Argenteuil, Ile De France 95100
FranceActive - Recruiting
Avicenne Hospital
Bobigny, Ile De France 93000
FranceActive - Recruiting
Hopital Saint Vincent de Paul
Lille, Nord 5900
FranceActive - Recruiting
Hopital Saint Vincent-de-Paul
Lille, Nord 5900
FranceActive - Recruiting
Hôpital Saint Vincent-de-Paul
Lille cedex, Nord 5900
FranceSite Not Available
CHU de Poitiers
Poitiers, Nouvelle Aquitaine 86000
FranceActive - Recruiting
Centre Hospitalier Universitaire (CHU) de Bordeaux
Pessac, Nouvelle-Aquitaine F33600
FranceActive - Recruiting
Nantes University Hospital
Nantes, Pays De La Loire 44093
FranceActive - Recruiting
Centre Hospitalier Metropole Savoie
Chambery, Savoie 73000
FranceActive - Recruiting
Gustave Roussy
Villejuif, Val De Marne / Ile De France 94805
FranceActive - Recruiting
Centre Hospitalier Universitaire Angers
Angers, 49933
FranceActive - Recruiting
Centre Hospitalier Universitaire Angers (CHU Angers)
Angers, 49933
FranceActive - Recruiting
Change Annecy
Metz Tessy, 74374
FranceActive - Recruiting
CHU Nimes Institut de Cancerologie
Nimes, 30029
FranceActive - Recruiting
Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, 75571
FranceActive - Recruiting
Saint Antoine Hospital
Paris, 75571
FranceActive - Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42055
FranceActive - Recruiting
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg 70376
GermanyActive - Recruiting
Kliniken Ostalb Stauferklinikum Schwab Gmund
Mutlangen, Gmund D-73557
GermanyActive - Recruiting
Clinic Frankfurt (Oder)
Frankfurt, Hesse 15236
GermanyActive - Recruiting
University Hospital Essen
Essen, Nordrhein Westfalen 45122
GermanyActive - Recruiting
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, Rheinland-Pfalz 55131
GermanyActive - Recruiting
Hematological Praxis Dresden
Dresden, Sachsen 01307
GermanyActive - Recruiting
University Hospital Carl Gustav Carus
Dresden, 01307
GermanyActive - Recruiting
University Hospital, Medical Dept. I
Dresden, 01307
GermanyActive - Recruiting
Stadtisches Krankenhaus Kiel
Kiel, 24116
GermanyActive - Recruiting
University Medical Center of Mainz
Mainz, 55131
GermanyActive - Recruiting
Clinic Frankfurt (Oder)
Oder, 15236
GermanySite Not Available
Beaumont Hospital
Dublin, Leinster D09V2N0
IrelandActive - Recruiting
St James Hospital and Trinity College Dublin
Dublin, D08
IrelandActive - Recruiting
The Chaim Sheba Medical Center
Tel-Hashomer, Tel Aviv 5265601
IsraelActive - Recruiting
Samson Assuta Ashdod University Hospital
Ashdod, 7747629
IsraelActive - Recruiting
Bnai Zion Medical Center
Haifa, 31048
IsraelActive - Recruiting
Hadassah Medical Center
Jerusalem, 91200
IsraelActive - Recruiting
Galilee Medical Center
Nahariya, 2210001
IsraelActive - Recruiting
The Chaim Sheba Medical Center
Ramat Gan, 5262000
IsraelSite Not Available
The Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
IsraelActive - Recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola (fc), Forli Cesena 47014
ItalyActive - Recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei tumori
Meldola (fc), Forli-Cesena 47014
ItalyActive - Recruiting
ASST Monza Ospedale San Gerardo
Monza, Lombardy 20900
ItalyActive - Recruiting
Istituto Europeo di Oncologia
Milano, 20141
ItalyActive - Recruiting
A.O.U. di Modena
Modena, 41124
ItalyActive - Recruiting
Federico II University
Napoli, 80131
ItalyActive - Recruiting
AOU Maggiore della Carita
Novara, 28100
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Maggiore della Carita
Novara, 28100
ItalyActive - Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
ItalyActive - Recruiting
Azienda Ospedaliera di Perugia
Perugia, 06132
ItalyActive - Recruiting
Ospedale Santa Maria delle Croci
Ravenna, 48121
ItalyActive - Recruiting
Azienda Ospedaliero-Universitaria (AOU) Città della Salute e della Scienza di Torino
Torino, 10126
ItalySite Not Available
Hematology - Città della Salute e della Scienza di Torino
Turin, 10126
ItalyActive - Recruiting
Azienda Sanitaria Universitaria Friuli Centrale
Udine, 33100
ItalyActive - Recruiting
Hematology Clinic, Azienda Sanitaria Universitaria Friuli Centrale (ASUFC)
Udine, 33100
ItalyActive - Recruiting
Santa Maria della Misericordia
Udine, 33100
ItalyActive - Recruiting
St. Vincent Hospital - The Catholic University of Korea
Suwon-si, Gyeonggi-do 16247
Korea, Republic ofActive - Recruiting
St. Vincent Hospital, The Catholic University of Korea
Suwon-si, Gyeonggi-do 16247
Korea, Republic ofActive - Recruiting
Gachon University Gil Medical Center
Incheon, Namdong-Gu 405-760
Korea, Republic ofActive - Recruiting
Dong-A University Hospital
Busan, 49201
Korea, Republic ofActive - Recruiting
Inje University Busan Paik Hospital
Busan, 47392
Korea, Republic ofActive - Recruiting
Pusan National University Hospital
Busan, 49241
Korea, Republic ofActive - Recruiting
Keimyung University Dongsan Hospital
Daegu, 42601
Korea, Republic ofActive - Recruiting
Yeyungnam University Medical Center
Daegu, 42415
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul St Marys Hospital
Seoul, 137-701
Korea, Republic ofActive - Recruiting
Seoul st mary's hospital
Seoul, 06591
Korea, Republic ofActive - Recruiting
The Catholic University of Korea
Seoul, 137-701
Korea, Republic ofActive - Recruiting
Yeouido St Marys Hospital
Seoul, 07345
Korea, Republic ofActive - Recruiting
Yeouido St. Marys Hospital
Seoul, 07345
Korea, Republic ofActive - Recruiting
Hospital Ampang
Ampang, Pahang 68000
MalaysiaActive - Recruiting
Hospital Tg Ampuan Afzan
Kuantan, Pahang 25100
MalaysiaActive - Recruiting
Hospital Queen Elizabeth
Kota Kinabalu, Sabah 88200
MalaysiaActive - Recruiting
Subang Jaya Medical Center
Subang Jaya, Selangor 47500
MalaysiaActive - Recruiting
University Malaya Medical Centre
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur 59100
MalaysiaActive - Recruiting
Uniwersytecki Szpital Kliniczny
Wroclaw, Dolnoslaskie 50-367
PolandActive - Recruiting
Malopolskie Centrum Medyczne
Krakow, Malopolskie 30-510
PolandActive - Recruiting
Matopolskie Centrum Medyczne S.C.
Krakow, Malopolskie 30-510
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomerania 80-214
PolandActive - Recruiting
Pratia Poznan Medical Center
Poznan, Wielkopolska 60185
PolandActive - Recruiting
Szpital Uniwersytecki Nr2 Bydgoszcz
Bydgoszcz, 85-168
PolandActive - Recruiting
Szpital Szpecjalistyczny w Walbrzychu
Walbrzych, 58-300
PolandActive - Recruiting
National Cancer Centre of Singapore
Singapore, 168583
SingaporeActive - Recruiting
National University Hospital Singapore
Singapore, 119074
SingaporeActive - Recruiting
Tan Tock Seng Hospital
Singapore, 308433
SingaporeActive - Recruiting
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna 15706
SpainActive - Recruiting
Hospital Universitario Central De Asturias
Oviedo, Asturias 33011
SpainActive - Recruiting
Son Espases University Hospital
Palma, Balearic Islands 07120
SpainSuspended
Hospital Universitari Parc Tauli
Sabadell, Barcelona 08208
SpainActive - Recruiting
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona 08221
SpainActive - Recruiting
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
SpainActive - Recruiting
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcon, Madrid 28223
SpainActive - Recruiting
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid 28223
SpainSite Not Available
Hospital Sant Pau
Barcelona, 08041
SpainActive - Recruiting
Hospital Virgen De Las Nieves De Granada
Granada, 18014
SpainActive - Recruiting
Fundacion Jimenez Diaz University Hospital
Madrid, 28040
SpainActive - Recruiting
Hospital Universitario HM Sanchinarro
Madrid, 28050
SpainActive - Recruiting
Hospital Universitario HM Sanchinarro, Servicio de Hematologia
Madrid, 28050
SpainActive - Recruiting
Hospital Universitario Infanta Leonor
Madrid, 28031
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainActive - Recruiting
Hospital Universitario Virgen Macarena
Sevilla, 41009
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio
Sevilla, 41013
SpainActive - Recruiting
Hospital General Universitario de Toledo
Toledo, 45007
SpainActive - Recruiting
Instituto Valenciano de Oncologia
Valencia, 46009
SpainActive - Recruiting
University Hospital Doctor Peset
Valencia, 46017
SpainActive - Recruiting
Chiayi Chang Gung Memorial Hospital
Puzhi City, Chiayi 613
TaiwanSite Not Available
Chiayi Chang Gung Memorial Hospital
Puzi, Chiayi 613
TaiwanSite Not Available
Chiayi Chang Gung Memorial Hospital
Puzi City, Chiayi 613
TaiwanSite Not Available
Changhua Christian Hospital
Changhua City, 50006
TaiwanActive - Recruiting
Taipei Medical University - Shuang Ho Hospital
New Taipei City, 23561
TaiwanActive - Recruiting
Chang Gung Medical Foundation Chia Yi Branch
Puzi City, 613
TaiwanActive - Recruiting
Wanfang Hospital
Taipei, 00116
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei City, 10002
TaiwanActive - Recruiting
Chang Gung Memorial Hospital- Linkou Branch
Taoyuan, 333
TaiwanActive - Recruiting
Chulalongkorn University
Bangkok, Krung Thep Maha Nakhon [Bangko] 10330
ThailandActive - Recruiting
Sriraj Hospital
Bangkok, 10700
ThailandActive - Recruiting
Chaing Mai University
Chiang Mai, 50200
ThailandActive - Recruiting
Chiang Mai University
Chiang Mai, 50200
ThailandActive - Recruiting
Faculty of Medicine
Khon Kaen, 40002
ThailandActive - Recruiting
Khon Kaen University
Khon Kaen, 40002
ThailandActive - Recruiting
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Yenimahalle, Ankara 06200
TurkeyActive - Recruiting
VM Medical Park Mersin Hospital
Mezitli, Mersin 33200
TurkeyActive - Recruiting
Tekirdag Namik Kemal University Hospital
Tekirdag, Suleymanpasa 59100
TurkeyActive - Recruiting
Gazi Universitesi
Besevler, 6500
TurkeyActive - Recruiting
Istanbul University Istanbul Faculty of Medicine
Istanbul, 34418
TurkeyActive - Recruiting
Istanbul University, Istanbul Faculty of Medicine
Istanbul, 34418
TurkeyActive - Recruiting
Dokuz Eylul University
Izmir, 35340
TurkeyActive - Recruiting
Ege University
Izmir, 35100
TurkeyActive - Recruiting
Sakarya University Medical Faculty Hematology Department
Sakarya, 54290
TurkeyActive - Recruiting
Sakarya Universty Medical Faculty
Sakarya, 54290
TurkeyActive - Recruiting
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55239
TurkeyActive - Recruiting
NHS Grampian: Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
United KingdomActive - Recruiting
The Hillingdon Hospitals NHS Foundation Trust
Uxbridge, UB8 3NN
United KingdomActive - Recruiting
David Geffen School of Medicine at UCLA
Los Angeles, California 90095
United StatesActive - Recruiting
UC Irvine Health Chao Family Comprehensive Cancer Cente
Orange, California 92868
United StatesActive - Recruiting
UC Irvine Health Chao Family Comprehensive Cancer Center
Orange, California 92868
United StatesActive - Recruiting
University of California Irvine Medical Center
Orange, California 92868
United StatesActive - Recruiting
University of California (UC) Davis
Sacramento, California 95817-2229
United StatesActive - Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana 46202
United StatesActive - Recruiting
St Vincent Ascension at Peyton Manning Childrens Hospital
Indianapolis, Indiana 46260
United StatesActive - Recruiting
St. Vincent Ascension - Peyton Manning Children's Hospital
Indianapolis, Indiana 46260
United StatesActive - Recruiting
Clinical Research of Indiana
Noblesville, Indiana 46062
United StatesActive - Recruiting
Investigative Clinical Research of Indiana
Noblesville, Indiana 46062
United StatesActive - Recruiting
University of Kentucky
Lexington, Kentucky 40536
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesActive - Recruiting
Henry Ford Health System
Detroit, Michigan 48202
United StatesActive - Recruiting
Henry Ford Hospital
Detroit, Michigan 48202
United StatesActive - Recruiting
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United StatesActive - Recruiting
Stony Brook University Hospital
Stony Brook, New York 11794
United StatesActive - Recruiting
Clinical Research Alliance Inc
Westbury, New York 11590
United StatesActive - Recruiting
Duke University Medical Center
Durham, North Carolina 27710
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
Center for Oncology and Blood Disorders
Houston, Texas 77030
United StatesActive - Recruiting
Community Cancer Trials of Utah
Ogden, Utah 84405
United StatesActive - Recruiting
The Community Cancer Trials
Ogden, Utah 84405
United StatesActive - Recruiting
Prohealth Care Inc
Waukesha, Wisconsin 53188
United StatesActive - Recruiting
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