Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma

PHASE3RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

February 10, 2023

Primary Completion Date

March 31, 2031

Study Completion Date

March 31, 2031

Conditions
High-risk Large B-cell Lymphoma (LBCL)
Interventions
BIOLOGICAL

Axicabtagene Ciloleucel

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells

DRUG

Cyclophosphamide

Administered intravenously

DRUG

Fludarabine

Administered intravenously

DRUG

Etoposide

Administered intravenously

DRUG

Rituximab

Administered intravenously

DRUG

Doxorubicin

Administered intravenously

DRUG

Vincristine

Administered intravenously

DRUG

Prednisone

Administered orally

Trial Locations (90)

2050

RECRUITING

Royal Prince Alfred Hospital, Camperdown

3000

RECRUITING

Peter MacCallum Cancer Center, Melbourne

3100

RECRUITING

Universitätsklinikum St. Pölten, Sankt Pölten

4101

RECRUITING

Royal Brisbane and Women's Hospital, South Brisbane

5020

RECRUITING

Zuniklinikum Salzburg, Landeskrankenhaus, Universitatsklinik fur Innere Medizin III der PMU, Salzburg

6020

RECRUITING

Medizinische Universität Innsbruck, Innsbruck

8035

RECRUITING

Hospital Universitari Vall D'Hebron, Barcelona

10021

RECRUITING

Weill Cornell Medical College - NewYork Presbyterian Hospital, New York

10032

RECRUITING

Columbia University Medical Center, New York

10467

RECRUITING

Montefiore Medical Center, The Bronx

13125

RECRUITING

Helios Klinikum Berlin-Buch, Berlin

14203

RECRUITING

Roswell Park Cancer Institute, Buffalo

14642

RECRUITING

University of Rochester Medical Center, Rochester

15232

WITHDRAWN

UPMC Hillman Cancer Center, Pittsburgh

20089

RECRUITING

IRCCS Istituto Clinico Humanitas, Rozzano

20132

RECRUITING

Ospedale San Raffaele, Milan

21079

RECRUITING

CHU Dijon, Dijon

21201

RECRUITING

University of MD Greenebaum Comprehensive Cancer Center, Baltimore

23298

RECRUITING

Virginia Commonwealth University, Richmond

25123

RECRUITING

ASST Degli Spedali Civili di Brescia, Brescia

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

28204

RECRUITING

Novant Health Cancer Institute- Hematology, Charlotte

29615

RECRUITING

Prisma Health Cancer Institute, Greenville

30912

RECRUITING

Georgia Cancer Center at Augusta University, Augusta

31100

RECRUITING

Centre Hospitalier Universitaire(CHU) de Toulouse, Toulouse

33612

RECRUITING

Moffitt Cancer Center, Tampa

34295

RECRUITING

Hopital Saint Eloi, Montpellier

35033

RECRUITING

CHU Pontchaillou, Rennes

35233

RECRUITING

University of Alabama Hospital, Birmingham

37007

RECRUITING

Hospital Universitario de Salamanca, Salamanca

37203

RECRUITING

Tennessee Oncology, PLLC, Nashville

37232

RECRUITING

Henry-Joyce Cancer Center, Nashville

39008

RECRUITING

Hospital Universitario Marqués de Valdecilla, Santander

40065

RECRUITING

Norton Cancer Institute, St. Matthews Campus, Shelbyville

40138

RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna

40225

RECRUITING

Uniklinikum Duesseldorf, Klinik fuer Haematologie, Onkologie und klinische Immunologie, Düsseldorf

41013

RECRUITING

Hospital Universitario Virgen del Rocio, Seville

45242

RECRUITING

Oncology Hematology Care Clinical Trials, LLC, Cincinnati

46010

RECRUITING

Hospital Clínico Universitario de Valencia, Valencia

48109

RECRUITING

University of Michigan, Ann Arbor

52242

RECRUITING

University of Iowa, Iowa City

53127

RECRUITING

Universitätsklinikum bonn, medizinische klinik III, Bonn

55902

RECRUITING

Mayo Clinic Cancer Center Outpatient Pharmacy, Rochester

57105

WITHDRAWN

Avera Cancer Institute, Sioux Falls

59037

RECRUITING

Hopital Claude Huriez CHU Lille, Service Maladies du sang, Lille

60612

RECRUITING

Northwestern Memorial Hospital, Chicago

60637

RECRUITING

University of Chicago Medical Center, Chicago

62002

RECRUITING

Maastricht Universitair Medisch Centrum, Maastricht

66205

RECRUITING

The University of Kansas Hospital, Westwood

69008

RECRUITING

Centre Leon Berard, Cedex Lyon 08

70121

RECRUITING

Ochsner Clinic Foundation, New Orleans

75235

RECRUITING

University of Texas Southwestern Medical Center, Dallas

77030

RECRUITING

The University of Texas, MD Anderson Cancer Center, Houston

80218

RECRUITING

Colorado Blood Cancer Institute, Denver

84143

RECRUITING

Intermountain LDS Hospital/Blood and Marrow Transplant/ Acute Leukemia Program, Salt Lake City

85054

RECRUITING

Mayo Clinic, Phoenix

85234

RECRUITING

Banner MD Anderson Cancer Center, Gilbert

89133

RECRUITING

Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Reggio Calabria

90095

RECRUITING

University of California Los Angeles (UCLA), Los Angeles

92093

RECRUITING

UC San Diego Moores Cancer Center, La Jolla

94000

RECRUITING

Hopital Henri MONDOR, APHP, Paris

94305

RECRUITING

Stanford Cancer Institute, Palo Alto

98109

WITHDRAWN

Fred Hutchinson Cancer Center, Seattle

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

07601

RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

01090

RECRUITING

Medizinische Universität Wien (AKH Wien, Medical University Vienna and General Hospital Vienna), Vienna

H3T1E2

RECRUITING

Jewish General Hospital, Montreal

K1H 8L6

RECRUITING

The Ottowa Hospital- General Campus, Ottawa

M5G 2M9

RECRUITING

Princess Margaret Cancer Centre, Toronto

Unknown

RECRUITING

CHU Bordeaux-Hopital Haut-Leveque, Bordeaux

RECRUITING

Charite Universitaetsmedizin Berlin, Berlin

RECRUITING

Universitätsklinik Erlangen, Erlangen

RECRUITING

Universita Cattolica del Sacro Cuore, Rome

RECRUITING

Centro Hospitalar Universitario Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisbon

RECRUITING

Instituto Portugues de Oncologia de Lisboa Francisco Gentil - E.P.E., Lisbon

CS 23079

RECRUITING

Centre Hospitalier Universitaire de Nice, Nice

06132

RECRUITING

Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia, Perugia

602-8566,

RECRUITING

University Hospital, Kyoto Prefectural University of Medicine, Kyoto

980-8574

RECRUITING

Tohoku University Hospital, Miyagi

565-0871

RECRUITING

Osaka University Hospital, Osaka

113-8431

RECRUITING

Juntendo University Hospital, Tokyo

113-8677

RECRUITING

Tokyo Metropolitan Komagome Hospital, Tokyo

1081HV

RECRUITING

Academisch Medisch Centrum, Amsterdam

9700 RB

RECRUITING

University Medical Center Groningen, Groningen

2333 ZA

RECRUITING

Leiden University Medical Center, Leiden

3508 GA

RECRUITING

Universitair Medisch Centrum Utrecht, Utrecht

4200-072

RECRUITING

Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E., Porto

08908

RECRUITING

Institut Catala d'Oncologia, Barcelona

B15 2TH

RECRUITING

Addenbrookes Hospital (Cambridge University Hospitals NHS Foundation Trust), Birmingham

SO16 6YD

RECRUITING

University Hospitals Southampton, Southampton

All Listed Sponsors
lead

Kite, A Gilead Company

INDUSTRY