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
AustraliaSite Not Available
Calvary Mater Newcastle
Waratah, New South Wales 2298
AustraliaSite Not Available
Icon Cancer Centre
Auchenflower, Queensland 4066
AustraliaActive - Recruiting
Icon Cancer Centre - Wesley
Auchenflower, Queensland 4066
AustraliaSite Not Available
Pindara Private Hospital
Benowa, Queensland 4217
AustraliaSite Not Available
Epworth Freemasons
East Melbourne, Victoria 3121
AustraliaSite Not Available
Landeskrankenhaus Hochsteiermark
Leoben, Styria 8700
AustriaSite Not Available
Kepler University Hospital
Linz, Upper Austria 4020
AustriaSite Not Available
Medical University Graz
Graz, 8036
AustriaSite Not Available
Hanusch Krankenhaus
Vienna, 1140
AustriaSite Not Available
Medical University of Vienna
Vienna, 1090
AustriaSite Not Available
Klinikum Wels Grieskirchen
Wels, 4600
AustriaActive - Recruiting
Klinikum Wels-Grieskirchen
Wels, 4600
AustriaSite Not Available
Klinikum Wels-Grieskirchen GmbH
Wels, 4600
AustriaActive - Recruiting
AZ St.-Elisabeth Herentals vzw
Herentals, Antwerp 2200
BelgiumSite Not Available
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
AZ Delta
Roeselare, West Flanders 8800
BelgiumActive - Recruiting
Az Delta
Roeselare, West Vlaanderen 8800
BelgiumSite Not Available
Institut Jules Bordet
Brussels, 1000
BelgiumSite Not Available
Az st Elizabeth
Herentals, 2200
BelgiumActive - Recruiting
CHR de Verviers
Verviers, 4800
BelgiumActive - Recruiting
Centre Hospitalier Regional de Verviers
Verviers, 4800
BelgiumSite Not Available
Hospital Clinico Universidad de Los Andes
Santiago, Las Condes 7620157
ChileSite Not Available
Inmunocel
Santiago, Region Metropolitana 7580206
ChileSite Not Available
Clinica Alemana de Santiago
Santiago, 7650568
ChileSite Not Available
University Hospital Hradec Kralove
Hradec Kralove, East Bohemia 50005
CzechiaSite Not Available
University Hospital Hradec Kralove
Hradec Kralove 5, 50005
CzechiaSite Not Available
University Hospital Kralovske Vinohrady
Prague, 10034
CzechiaSite Not Available
Vseobecna Fakultni Nemocnice V Praze
Praha, 12808
CzechiaSite Not Available
Centre Hospitalier Universitaire (CHU) Rennes
Rennes, Bretagne 35033
FranceSite Not Available
CHRU de Tours
Tours, Centre Val De Loire 37044
FranceSite Not Available
Polyclinique Bordeaux Nord Aquitaine
Bordeaux Cedex, Gironde 33077
FranceSite Not Available
Hopital Victor Dupouy Argenteuil
Argenteuil, Ile De France 95100
FranceSite Not Available
Avicenne Hospital
Bobigny, Ile De France 93000
FranceSite Not Available
Hopital Saint Vincent de Paul
Lille, Nord 5900
FranceActive - Recruiting
Hopital Saint Vincent-de-Paul
Lille, Nord 5900
FranceSite Not Available
Hôpital Saint Vincent-de-Paul
Lille cedex, Nord 5900
FranceSite Not Available
CHU de Poitiers
Poitiers, Nouvelle Aquitaine 86000
FranceSite Not Available
Centre Hospitalier Universitaire (CHU) de Bordeaux
Pessac, Nouvelle-Aquitaine F33600
FranceSite Not Available
Nantes University Hospital
Nantes, Pays De La Loire 44093
FranceSite Not Available
Centre Hospitalier Metropole Savoie
Chambery, Savoie 73000
FranceSite Not Available
Gustave Roussy
Villejuif, Val De Marne / Ile De France 94805
FranceSite Not Available
Centre Hospitalier Universitaire Angers
Angers, 49933
FranceSite Not Available
Centre Hospitalier Universitaire Angers (CHU Angers)
Angers, 49933
FranceActive - Recruiting
Change Annecy
Metz Tessy, 74374
FranceSite Not Available
CHU Nimes Institut de Cancerologie
Nimes, 30029
FranceSite Not Available
Assistance Publique-Hopitaux de Paris (AP-HP)
Paris, 75571
FranceSite Not Available
Saint Antoine Hospital
Paris, 75571
FranceActive - Recruiting
CHU de Saint-Etienne
Saint-Etienne, 42055
FranceSite Not Available
Robert-Bosch-Krankenhaus
Stuttgart, Baden-Wurttemberg 70376
GermanySite Not Available
Kliniken Ostalb Stauferklinikum Schwab Gmund
Mutlangen, Gmund D-73557
GermanySite Not Available
Clinic Frankfurt (Oder)
Frankfurt, Hesse 15236
GermanySite Not Available
University Hospital Essen
Essen, Nordrhein Westfalen 45122
GermanySite Not Available
Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR
Mainz, Rheinland-Pfalz 55131
GermanySite Not Available
Hematological Praxis Dresden
Dresden, Sachsen 01307
GermanySite Not Available
University Hospital Carl Gustav Carus
Dresden, 01307
GermanySite Not Available
University Hospital, Medical Dept. I
Dresden, 01307
GermanyActive - Recruiting
Stadtisches Krankenhaus Kiel
Kiel, 24116
GermanySite Not Available
University Medical Center of Mainz
Mainz, 55131
GermanyActive - Recruiting
Clinic Frankfurt (Oder)
Oder, 15236
GermanySite Not Available
Beaumont Hospital
Dublin, Leinster D09V2N0
IrelandSite Not Available
St James Hospital and Trinity College Dublin
Dublin, D08
IrelandSite Not Available
The Chaim Sheba Medical Center
Tel-Hashomer, Tel Aviv 5265601
IsraelSite Not Available
Samson Assuta Ashdod University Hospital
Ashdod, 7747629
IsraelSite Not Available
Bnai Zion Medical Center
Haifa, 31048
IsraelSite Not Available
Hadassah Medical Center
Jerusalem, 91200
IsraelSite Not Available
Galilee Medical Center
Nahariya, 2210001
IsraelSite Not Available
The Chaim Sheba Medical Center
Ramat Gan, 5262000
IsraelSite Not Available
The Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
IsraelSite Not Available
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola (fc), Forli Cesena 47014
ItalySite Not Available
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
ItalySite Not Available
Istituto Europeo di Oncologia
Milano, 20141
ItalySite Not Available
A.O.U. di Modena
Modena, 41124
ItalySite Not Available
Federico II University
Napoli, 80131
ItalySite Not Available
AOU Maggiore della Carita
Novara, 28100
ItalySite Not Available
Azienda Ospedaliero Universitaria Maggiore della Carita
Novara, 28100
ItalyActive - Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
ItalySite Not Available
Azienda Ospedaliera di Perugia
Perugia, 06132
ItalySite Not Available
Ospedale Santa Maria delle Croci
Ravenna, 48121
ItalySite Not Available
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
ItalySite Not Available
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
ItalySite Not Available
St. Vincent Hospital - The Catholic University of Korea
Suwon-si, Gyeonggi-do 16247
Korea, Republic ofSite Not Available
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 21565
Korea, Republic ofSite Not Available
Dong-A University Hospital
Busan, 49201
Korea, Republic ofSite Not Available
Inje University Busan Paik Hospital
Busan, 47392
Korea, Republic ofSite Not Available
Pusan National University Hospital
Busan, 49241
Korea, Republic ofSite Not Available
Keimyung University Dongsan Hospital
Daegu, 42601
Korea, Republic ofSite Not Available
Yeyungnam University Medical Center
Daegu, 42415
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul St Marys Hospital
Seoul, 137-701
Korea, Republic ofSite Not Available
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 ofSite Not Available
Hospital Ampang
Ampang, Pahang 68000
MalaysiaSite Not Available
Hospital Tg Ampuan Afzan
Kuantan, Pahang 25100
MalaysiaSite Not Available
Hospital Queen Elizabeth
Kota Kinabalu, Sabah 88200
MalaysiaSite Not Available
Subang Jaya Medical Center
Subang Jaya, Selangor 47500
MalaysiaSite Not Available
University Malaya Medical Centre
Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur 59100
MalaysiaSite Not Available
Uniwersytecki Szpital Kliniczny
Wroclaw, Dolnoslaskie 50-367
PolandSite Not Available
Malopolskie Centrum Medyczne
Krakow, Malopolskie 30-510
PolandActive - Recruiting
Matopolskie Centrum Medyczne S.C.
Krakow, Malopolskie 30-510
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomerania 80-214
PolandActive - Recruiting
Pratia Poznan Medical Center
Poznan, Wielkopolska 60185
PolandSite Not Available
Szpital Uniwersytecki Nr2 Bydgoszcz
Bydgoszcz, 85-168
PolandSite Not Available
Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center
Gdansk, 80-952
PolandSite Not Available
Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-954
PolandSite Not Available
Szpital Szpecjalistyczny w Walbrzychu
Walbrzych, 58-300
PolandSite Not Available
National Cancer Centre of Singapore
Singapore, 168583
SingaporeSite Not Available
National University Hospital Singapore
Singapore, 119074
SingaporeSite Not Available
Tan Tock Seng Hospital
Singapore, 308433
SingaporeSite Not Available
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna 15706
SpainSite Not Available
Hospital Universitario Central De Asturias
Oviedo, Asturias 33011
SpainSite Not Available
Son Espases University Hospital
Palma, Balearic Islands 07120
SpainSite Not Available
Hospital Universitari Parc Tauli
Sabadell, Barcelona 08208
SpainSite Not Available
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona 08221
SpainSite Not Available
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
SpainSite Not Available
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcon, Madrid 28223
SpainSite Not Available
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid 28223
SpainSite Not Available
Hospital Universitario de Navarra
Pamplona, Navarra 31008
SpainSite Not Available
Hospital Sant Pau
Barcelona, 08041
SpainSite Not Available
Hospital Virgen De Las Nieves De Granada
Granada, 18014
SpainSite Not Available
Fundacion Jimenez Diaz University Hospital
Madrid, 28040
SpainSite Not Available
Hospital Universitario HM Sanchinarro
Madrid, 28050
SpainActive - Recruiting
Hospital Universitario HM Sanchinarro, Servicio de Hematologia
Madrid, 28050
SpainSite Not Available
Hospital Universitario Infanta Leonor
Madrid, 28031
SpainSite Not Available
Hospital Universitario Ramon y Cajal
Madrid, 28034
SpainSite Not Available
Hospital Universitario Virgen Macarena
Sevilla, 41009
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Sevilla, 41013
SpainSite Not Available
Hospital General Universitario de Toledo
Toledo, 45007
SpainSite Not Available
Instituto Valenciano de Oncologia
Valencia, 46009
SpainSite Not Available
University Hospital Doctor Peset
Valencia, 46017
SpainSite Not Available
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
TaiwanSite Not Available
Taipei Medical University - Shuang Ho Hospital
New Taipei City, 23561
TaiwanSite Not Available
Chang Gung Medical Foundation Chia Yi Branch
Puzi City, 613
TaiwanSite Not Available
Wanfang Hospital
Taipei, 00116
TaiwanSite Not Available
National Taiwan University Hospital
Taipei City, 10002
TaiwanSite Not Available
Chang Gung Memorial Hospital- Linkou Branch
Taoyuan, 333
TaiwanSite Not Available
Chulalongkorn University
Bangkok, Krung Thep Maha Nakhon [Bangko] 10330
ThailandSite Not Available
Sriraj Hospital
Bangkok, 10700
ThailandSite Not Available
Chaing Mai University
Chiang Mai, 50200
ThailandSite Not Available
Chiang Mai University
Chiang Mai, 50200
ThailandActive - Recruiting
Faculty of Medicine
Khon Kaen, 40002
ThailandSite Not Available
Khon Kaen University
Khon Kaen, 40002
ThailandActive - Recruiting
Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Yenimahalle, Ankara 06200
TurkeySite Not Available
VM Medical Park Mersin Hospital
Mezitli, Mersin 33200
TurkeySite Not Available
Tekirdag Namik Kemal University Hospital
Tekirdag, Suleymanpasa 59100
TurkeySite Not Available
Gazi Universitesi
Besevler, 6500
TurkeySite Not Available
Istanbul University Istanbul Faculty of Medicine
Istanbul, 34418
TurkeySite Not Available
Istanbul University, Istanbul Faculty of Medicine
Istanbul, 34418
TurkeyActive - Recruiting
Dokuz Eylul University
Izmir, 35340
TurkeySite Not Available
Ege University
Izmir, 35100
TurkeySite Not Available
Sakarya University Medical Faculty Hematology Department
Sakarya, 54290
TurkeyActive - Recruiting
Sakarya Universty Medical Faculty
Sakarya, 54290
TurkeySite Not Available
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55239
TurkeySite Not Available
NHS Grampian: Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
United KingdomSite Not Available
The Hillingdon Hospitals NHS Foundation Trust
Uxbridge, UB8 3NN
United KingdomSite Not Available
David Geffen School of Medicine at UCLA
Los Angeles, California 90095
United StatesSite Not Available
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 StatesSite Not Available
University of California (UC) Davis
Sacramento, California 95817-2229
United StatesSite Not Available
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana 46202
United StatesSite Not Available
St Vincent Ascension at Peyton Manning Childrens Hospital
Indianapolis, Indiana 46260
United StatesSite Not Available
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 StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40536
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Henry Ford Health System
Detroit, Michigan 48202
United StatesSite Not Available
Henry Ford Hospital
Detroit, Michigan 48202
United StatesActive - Recruiting
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan 49503
United StatesSite Not Available
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United StatesSite Not Available
Stony Brook University Hospital
Stony Brook, New York 11794
United StatesSite Not Available
Clinical Research Alliance Inc
Westbury, New York 11590
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
Center for Oncology and Blood Disorders
Houston, Texas 77030
United StatesSite Not Available
Community Cancer Trials of Utah
Ogden, Utah 84405
United StatesSite Not Available
The Community Cancer Trials
Ogden, Utah 84405
United StatesActive - Recruiting
Prohealth Care Inc
Waukesha, Wisconsin 53188
United StatesSite Not Available

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