A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Patients With Previously Untreated Diffuse Large B-cell Lymphoma

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

904

Participants

Timeline

Start Date

December 13, 2023

Primary Completion Date

March 30, 2028

Study Completion Date

April 30, 2029

Conditions
Diffuse Large B-cell Lymphoma (DLBCL)
Interventions
DRUG

Odronextamab

Odronextamab will be administered by intravenous (IV) infusion

DRUG

Rituximab

Rituximab will be administered IV, or subcutaneously (SC)

DRUG

Cyclophosphamide

Cyclophosphamide will be administered IV as part of chemotherapy

DRUG

Doxorubicin

Doxorubicin will be administered IV as part of chemotherapy

DRUG

Vincristine

Vincristine will be administered IV as part of chemotherapy

DRUG

Prednisone/Prednisolone

Prednisone or prednisolone will be administered orally (PO) as part of chemotherapy

Trial Locations (149)

333

Chang Gung Memorial Hospital- Linkou Branch, Taoyuan District

613

Chang Gung Medical Foundation Chia Yi Branch, Buzi

1000

Institut Jules Bordet, Brussels

1090

Medical University of Vienna, Vienna

1140

Hanusch Krankenhaus, Vienna

2170

Liverpool Hospital, Liverpool

2200

AZ St.-Elisabeth Herentals vzw, Herentals

2298

Calvary Mater Newcastle, Waratah

3121

Epworth Freemasons, East Melbourne

4020

Kepler University Hospital, Linz

4066

Icon Cancer Centre - Wesley, Auchenflower

4217

Pindara Private Hospital, Benowa

4600

Klinikum Wels-Grieskirchen, Wels

4800

Centre Hospitalier Regional de Verviers, Verviers

5900

Hopital Saint Vincent-de-Paul, Lille

6500

Gazi Universitesi, Beşevler

8036

Medical University Graz, Graz

8700

Landeskrankenhaus Hochsteiermark, Leoben

8800

Az Delta, Roeselare

9000

Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital, Ghent

10002

National Taiwan University Hospital, Taipei

10034

University Hospital Kralovske Vinohrady, Prague

10126

Hematology - Città della Salute e della Scienza di Torino, Turin

10330

Chulalongkorn University, Bangkok

10700

Sriraj Hospital, Bangkok

11590

Clinical Research Alliance Inc, Westbury

11794

Stony Brook University Hospital, Stony Brook

12808

Vseobecna Fakultni Nemocnice V Praze, Prague

15236

Clinic Frankfurt (Oder), Frankfurt am Main

15706

Hospital Clinico Universitario Santiago de Compostela, Santiago de Compostela

16247

St. Vincent Hospital - The Catholic University of Korea, Suwon

18014

Hospital Virgen De Las Nieves De Granada, Granada

20141

Istituto Europeo di Oncologia, Milan

20900

ASST Monza Ospedale San Gerardo, Monza

21565

Gachon University Gil Medical Center, Incheon

23561

Taipei Medical University - Shuang Ho Hospital, New Taipei City

24116

Stadtisches Krankenhaus Kiel, Kiel

25100

Hospital Tg Ampuan Afzan, Kuantan

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

27710

Duke University Medical Center, Durham

28031

Hospital Universitario Infanta Leonor, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28040

Fundacion Jimenez Diaz University Hospital, Madrid

28050

Hospital Universitario HM Sanchinarro, Servicio de Hematologia, Madrid

28100

AOU Maggiore della Carita, Novara

28223

Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcón

30029

CHU Nimes Institut de Cancerologie, Nîmes

31008

Hospital Universitario de Navarra, Pamplona

31048

Bnai Zion Medical Center, Haifa

33011

Hospital Universitario Central De Asturias, Oviedo

33077

Polyclinique Bordeaux Nord Aquitaine, Bordeaux

33100

Santa Maria della Misericordia, Udine

33200

VM Medical Park Mersin Hospital, Mezitli

34418

Istanbul University Istanbul Faculty of Medicine, Istanbul

35033

Centre Hospitalier Universitaire (CHU) Rennes, Rennes

35100

Ege University, Izmir

35340

Dokuz Eylul University, Izmir

37044

CHRU de Tours, Tours

39008

Hospital Universitario Marques de Valdecilla, Santander

40002

Faculty of Medicine, Khon Kaen

40536

University of Kentucky, Lexington

41009

Hospital Universitario Virgen Macarena, Seville

41013

Hospital Universitario Virgen del Rocio, Seville

41124

A.O.U. di Modena, Modena

42055

CHU de Saint-Etienne, Saint-Etienne

42415

Yeyungnam University Medical Center, Daegu

42601

Keimyung University Dongsan Hospital, Daegu

44093

Nantes University Hospital, Nantes

44106

University Hospitals Cleveland Medical Center, Cleveland

45007

Hospital General Universitario de Toledo, Toledo

45122

University Hospital Essen, Essen

46009

Instituto Valenciano de Oncologia, Valencia

46017

University Hospital Doctor Peset, Valencia

46062

Investigative Clinical Research of Indiana, Noblesville

46202

Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis

46260

St Vincent Ascension at Peyton Manning Childrens Hospital, Indianapolis

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (fc)

47392

Inje University Busan Paik Hospital, Busan

47500

Subang Jaya Medical Center, Subang Jaya

48121

Ospedale Santa Maria delle Croci, Ravenna

48202

Henry Ford Health System, Detroit

49201

Dong-A University Hospital, Busan

49241

Pusan National University Hospital, Busan

49503

Cancer and Hematology Centers of Western Michigan, Grand Rapids

49933

Centre Hospitalier Universitaire Angers, Angers

50005

University Hospital Hradec Kralove, Hradec Králové

50006

Changhua Christian Hospital, Changhua

50200

Chaing Mai University, Chiang Mai

53188

Prohealth Care Inc, Waukesha

54290

Sakarya Universty Medical Faculty, Sakarya

55131

Universitaetsmedizin der Johannes Gutenberg Universitaet Mainz KoeR, Mainz

55239

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi, Samsun

59100

University Malaya Medical Centre, Kuala Lumpur

Tekirdag Namik Kemal University Hospital, Tekirdağ

60185

Pratia Poznan Medical Center, Poznan

64239

The Tel Aviv Sourasky Medical Center, Tel Aviv

68000

Hospital Ampang, Ampang

70376

Robert-Bosch-Krankenhaus, Stuttgart

73000

Centre Hospitalier Metropole Savoie, Chambéry

74374

Change Annecy, Metz-Tessy

75571

Assistance Publique-Hopitaux de Paris (AP-HP), Paris

77030

Center for Oncology and Blood Disorders, Houston

80131

Federico II University, Napoli

84405

Community Cancer Trials of Utah, Ogden

86000

CHU de Poitiers, Poitiers

88200

Hospital Queen Elizabeth, Kota Kinabalu

90095

David Geffen School of Medicine at UCLA, Los Angeles

91200

Hadassah Medical Center, Jerusalem

92868

University of California Irvine Medical Center, Orange

93000

Avicenne Hospital, Bobigny

94805

Gustave Roussy, Villejuif

95100

Hopital Victor Dupouy Argenteuil, Argenteuil

119074

National University Hospital Singapore, Singapore

168583

National Cancer Centre of Singapore, Singapore

308433

Tan Tock Seng Hospital, Singapore

2210001

Galilee Medical Center, Nahariya

5265601

The Chaim Sheba Medical Center, Tel Litwinsky

7580206

Inmunocel, Santiago

7620157

Hospital Clinico Universidad de Los Andes, Santiago

7650568

Clinica Alemana de Santiago, Santiago

7747629

Samson Assuta Ashdod University Hospital, Ashdod

95817-2229

University of California (UC) Davis, Sacramento

02215

Beth Israel Deaconess Medical Center, Boston

08901

Rutgers Cancer Institute of New Jersey, New Brunswick

F33600

Centre Hospitalier Universitaire (CHU) de Bordeaux, Pessac

D-73557

Kliniken Ostalb Stauferklinikum Schwab Gmund, Mutlangen

01307

Hematological Praxis Dresden, Dresden

University Hospital Carl Gustav Carus, Dresden

D09V2N0

Beaumont Hospital, Dublin

D08

St James Hospital and Trinity College Dublin, Dublin

06132

Azienda Ospedaliera di Perugia, Perugia

30-510

Matopolskie Centrum Medyczne S.C., Krakow

50-367

Uniwersytecki Szpital Kliniczny, Wroclaw

85-168

Szpital Uniwersytecki Nr2 Bydgoszcz, Bydgoszcz

80-952

Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center, Gdansk

20-954

Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Lublin

58-300

Szpital Szpecjalistyczny w Walbrzychu, Wałbrzych

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

07345

Yeouido St. Marys Hospital, Seoul

137-701

Seoul St Marys Hospital, Seoul

07120

Son Espases University Hospital, Palma

08208

Hospital Universitari Parc Tauli, Sabadell

08221

Hospital Universitari Mutua Terrassa, Terrassa

08041

Hospital Sant Pau, Barcelona

00116

Wanfang Hospital, Taipei

06200

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital, Yenimahalle

AB25 2ZN

NHS Grampian: Aberdeen Royal Infirmary, Aberdeen

UB8 3NN

The Hillingdon Hospitals NHS Foundation Trust, Uxbridge

All Listed Sponsors
lead

Regeneron Pharmaceuticals

INDUSTRY

NCT06091865 - A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Patients With Previously Untreated Diffuse Large B-cell Lymphoma | Biotech Hunter | Biotech Hunter