Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma

PHASE3CompletedINTERVENTIONAL
Enrollment

359

Participants

Timeline

Start Date

January 25, 2018

Primary Completion Date

March 18, 2021

Study Completion Date

November 25, 2024

Conditions
Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Interventions
BIOLOGICAL

Axicabtagene Ciloleucel

A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide

DRUG

Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.

Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.

DRUG

Cyclophosphamide

Administered intravenously

DRUG

Fludarabine

Administered intravenously

Trial Locations (72)

3000

Peter MacCallum Cancer Center, Melbourne

6020

Universitatsklinikum Graz, Division of Hematology, Graz

Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie und Onkologie, Innsbruck

6500

IOSI, OSpedale Regionale Bellinzona e Valli, Bellinzona

8091

University Hospital Zurich, Zurich

10021

Memorial Sloan Kettering Cancer Center, New York

10029

Icahn School of Medicine at Mount Sinai, New York

12902

Moffitt Cancer Center, Tampa

14642

University of Rochester Medical Center, Rochester

15213

UPMC Hillman Cancer Center, Pittsburgh

19107

Thomas Jefferson University, Philadelphia

20132

IRCCS Ospedale San Raffaele di Milano, Milan

20246

Universitatsklinikum Hamburg-Eppendorf, Hamburg

21201

University of Maryland, Greenbaum Comprehensive Cancer Center, Baltimore

22908

University of Virginia Health System, Charlottesville

28046

Hospital Universitario La Paz, Madrid

31008

Clinica Universidad de Navarra, Pamplona

33136

University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center, Miami

35033

Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou, Rennes

37007

Hospital Universitario de Salamanca, Salamanca

37075

Universitatsmedizin Gottingen, Göttingen

37203

Sarah Cannon Research Institute, Nashville

37232

Henry-Joyce Cancer Center, Nashville

40138

"Instituto di Ematologia L. e A. Seragnoli - Dipartimento di Medicina Specialistica Diagnostica e Sperimentale", Bologna

43210

James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center, Columbus

44195

Cleveland Clinic, Cleveland

48201

Barbara Ann Karmanos Cancer Institute, Detroit

52242

University of Iowa Hospitals and Clinincs, Iowa City

55905

Mayo Clinic, Patient Location, Rochester

59037

CHRU de Lille - Hopital Claude Huriez, Lille

60612

Northwestern University, Chicago

60637

University of Chicago Medical Center, Chicago

63130

Washington University School of Medicine, St Louis

66160

The University of Kansas Cancer Center, Kansas City

69120

Universitätsklinikum Heidelberg, Heidelberg

69495

Centre Hospitalier Lyon-Sud - Service d'Hematologie clinique, Pierre-Bénite

75010

Hopital Saint-Louis, Paris

75185

Uppsala Akademiska Sjukhus, Uppsala

77030

The University of Texas, MD Anderson Cancer Center, Houston

84112

University of Utah, Huntsman Cancer Institute, Salt Lake City

85054

Mayo Clinic Hospital, Phoenix

85234

Banner MD Anderson Cancer Center, Gilbert

90404

UCLA, Santa Monica

92093

UC San Diego Moores Cancer Center, La Jolla

94305

Stanford Cancer Institute, Stanford

97080

Universitäts-klinikum Würzburg, Würzburg

98104

Swedish Cancer Institute, Seattle

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

02215

Dana-Farber Cancer Institute, Boston

07601

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

Unknown

Cliniques Universiaires Saint-Luc, Brussels

UZ Gasthuisberg, Leuven

Vancouver General Hospital, Vancouver

University Medical Center Utrecht, Utrecht

R3E 0V9

CancerCare Manitoba, Winnipeg

M5G 2M9

Uninversity Health Network - Princess Margaret Cancer Center, Toronto

H4A 3J1

McGill University Health Center, Montreal

B3H 2Y9

QEII Health Sciences Centre, Halifax

H1T 2M4

Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont, Montreal

K1H 8L6

The Ottawa Hospital - General Campus, Ottawa

G1J 1Z4

CHU de Quebec-Universite Laval, Hopital de L'Enfante-Jesus, Québec

01307

Universitäts-klinikum Dresden, Dresden

1105 AZ

Academic Medical Center, Amsterdam

9700 RB

University Medical Center Groningen, Groningen

3011PL

Erasmus Medical Center, Rotterdam

08036

Hospital Clinic de Barcelona, Barcelona

08908

Institut Catala d'Oncologia, Barcelona

B15 2GW

University Hospitals Birmingham NHS Foundation Trust, Birmingham

EC1A 7BE

Barts Health NHS Trust, London

NW3 2QG

University College London Hospitals NHS Foundation Trust, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

All Listed Sponsors
lead

Kite, A Gilead Company

INDUSTRY

NCT03391466 - Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma | Biotech Hunter | Biotech Hunter