Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

231

Participants

Timeline

Start Date

September 22, 2022

Primary Completion Date

October 31, 2030

Study Completion Date

October 31, 2030

Conditions
Relapsed/Refractory Follicular Lymphoma
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

Lenalidomide

Administered orally

DRUG

Rituximab

Administered intravenously

DRUG

Doxorubicin

Administered intravenously

DRUG

Vincristine

Administered intravenously

DRUG

Prednisone

Administered orally

DRUG

Bendamustine

Administered intravenously

Trial Locations (52)

13273

Institut Paoli-Calmettes, Marseille

17033

Penn State Milton S. Hershey Medical Center, Hershey

20089

Istituto Clinico Humanitas-IRCCS, Rozzano

20100

Fondazione IRCCS - Istituto Nazionale Tumori, Milan

20132

Ospedale San Raffaele, Milan

21079

CHU de Dijon, Dijon

21201

University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore

23298

Virginia Commonwealth University, Richmond

24128

ASST Papa Giovanni XXIII, Bergamo

28009

Hospital General Universitario Gregorio Maranon, Madrid

28041

Hospital 12 de Octubre, Madrid

28204

Novant Health Cancer Institute Hematology - Charlotte, Charlotte

33604

CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie, Pessac

33612

Moffitt Cancer Center, Tampa

34295

Hopital Saint Eloi, Montpellier

35033

Hopital Pontchaillou - CHU Rennes, Rennes

37007

Hospital Universitario de Salamanca, Salamanca

37075

Universitatsmedizin Gottingen, Göttingen

37203

TriStar Centennial Medical Center - Cell Processing, Nashville

37232

Henry-Joyce Cancer Clinic, Nashville

40138

Azienda Ospedallero-Universitaria di Bologna Policlinico Sant'Orsola-Malpighi, Bologna

41013

Hospital Universitario Virgen del Rocio, Seville

42123

Arcispedale Santa Maria Nuova, Reggio Emilia

46010

Hospital Clínico Universitario de Valencia, Valencia

59037

Hôpital Claude Huriez-CHU de Lille, Lille

66205

The University of Kansas Hospital, Westwood

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

75013

Hopital Pitie-Salpetriere, Paris

76038

Centre Henri Becquerel, Rouen

77030

The University of Texas MD Anderson Cancer Center, Houston

86021

CHU de Poitiers, Poitiers

91010

City of Hope (City of Hope National Medical Center, City of Hope Medical Center), Duarte

94010

Hopital Henri Mondor, Créteil

94305

Stanford Health Care, Stanford

97080

Universitatsklinikum Koln Klinik I fur Innere Medizin, Würzburg

02215

Dana-Farber Cancer Institute, Boston

663-8501

Hyogo Medical University Hospital, Hyōgo

602-8566,

University Hospital Kyoto Prefectural University of Medicine, Kyoto

980-8574

Tohoku University Hospital, Miyagi

700-8558

Okayama University Hospital, Okayama

565-0871

Osaka University Hospital, Osaka

08035

Hospital Universitari Vall d'Hebrón, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

08908

Instituto Catalan de Oncologia - Hospital Duran i Reynolds (ICO L'Hospitalet), Barcelona

B15 2GW

University Hospital Birmingham NHS Foundation Trust, Birmingham

CB2 2QQ

Cambridge University Hospitals NHS Foundation Trust, Cambridge

NW2 2QG

University College London Hospitals NHS Foundation Trust, London

SE5 9RS

King's College Hospital NHS Foundation Trust, London

M20 4BX

The Christie NHS Foundation Trust, Manchester

OX3 7LE

Oxford University Hospitals NHS Foundation Trust, Oxford

SO16 6YD

The University Hospital Southampton NHS Foundation Trust, Southampton

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

All Listed Sponsors
lead

Kite, A Gilead Company

INDUSTRY