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

Last updated: October 14, 2025
Sponsor: Kite, A Gilead Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Follicular Lymphoma

Lymphoma

Treatment

Fludarabine

Cyclophosphamide

Doxorubicin

Clinical Study ID

NCT05371093
KT-US-473-0133
2021-003260-28
2024-511594-30
  • Ages > 18
  • All Genders

Study Summary

The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)

  • Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-riskdisease with relapse or progression within 24 months of the initial course ofchemoimmunotherapy (ie, POD24), Or r/r disease after ≥ 2 prior systemic lines oftherapy

  • Clinical indication for treatment.

  • At least 1 measurable lesion per the Lugano Classification {Cheson 2014}

  • Adequate renal, hepatic, pulmonary, and cardiac function

Exclusion

Key Exclusion Criteria:

  • Presence of large B cell lymphoma or transformed FL

  • Small lymphocytic lymphoma

  • Lymphoplasmacytic lymphoma

  • Full-thickness involvement of the gastric wall by lymphoma

  • FL Grade 3b

  • Prior CD19-targeted therapy

  • Prior CAR therapy or other genetically modified T-cell therapy

  • Uncontrolled fungal, bacterial, viral, or other infection

  • Active Infection with human immunodeficiency virus, hepatitis B virus or hepatitis Cvirus

  • History or presence of a clincially significant central nervous system (CNS)disorder.

  • History of autoimmune disease

  • Known history or CNS lymphoma involvement

  • Cardiac lymphoma involvement

  • History of clinically significant cardiac disease 6 months before randomization

  • Neuropathy greater than grade 2

  • Females who are pregnant or breastfeeding

  • Individuals of both genders who are not willing to practice birth control

  • Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube,indwelling Foley catheter, biliary drain, G/J-tube, pleural/peritoneal/pericardialcatheter, or Ommaya reservoirs). Dedicated central venous access catheters such asPort-a-Cath or Hickman catheter are permitted.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 231
Treatment Group(s): 9
Primary Treatment: Fludarabine
Phase: 3
Study Start date:
September 22, 2022
Estimated Completion Date:
October 31, 2030

Study Description

Five years after the last study participant is randomized, participants who have received axicabtagene ciloleucel will transition to a separate Long-term Follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Connect with a study center

  • Hopital Henri Mondor

    Créteil, 94010
    France

    Site Not Available

  • Hopital Henri Mondor

    Créteil 3022530, 94010
    France

    Site Not Available

  • CHU de Dijon

    Dijon, 21079
    France

    Site Not Available

  • CHU de Dijon

    Dijon 3021372, 21079
    France

    Site Not Available

  • Hôpital Claude Huriez-CHU de Lille

    Lille 2998324, 59037
    France

    Site Not Available

  • Hôpital Claude Huriez-CHU de Lille

    Lille cedex, 59037
    France

    Site Not Available

  • Institut Paoli-Calmettes

    Marseille, 13273
    France

    Site Not Available

  • Institut Paoli-Calmettes

    Marseille 2995469, 13273
    France

    Site Not Available

  • Hopital Saint Eloi

    Montpellier, 34295
    France

    Site Not Available

  • Hopital Saint Eloi

    Montpellier 2992166, 34295
    France

    Site Not Available

  • Hopital Pitie-Salpetriere

    Paris, 75013
    France

    Site Not Available

  • Hopital Pitie-Salpetriere

    Paris 2988507, 75013
    France

    Site Not Available

  • CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie

    Pessac, 33604
    France

    Site Not Available

  • CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie

    Pessac 2987805, 33604
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud

    Pierre Benite, 69495
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite 2987314, 69495
    France

    Site Not Available

  • CHU de Poitiers

    Poitiers, 86021
    France

    Site Not Available

  • CHU de Poitiers

    Poitiers 2986495, 86021
    France

    Site Not Available

  • Hopital Pontchaillou - CHU Rennes

    Rennes, 35033
    France

    Site Not Available

  • Hopital Pontchaillou - CHU Rennes

    Rennes 2983990, 35033
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen, 76038
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen 2982652, 76038
    France

    Site Not Available

  • Helios Klinikum Berlin-Buch

    Berlin, 13125
    Germany

    Site Not Available

  • Universitatsklinikum Koln Klinik I fur Innere Medizin

    Cologne, 50937
    Germany

    Site Not Available

  • Universitatsmedizin Gottingen

    Göttingen, 37075
    Germany

    Site Not Available

  • Universitatsmedizin Gottingen

    Göttingen 2918632, 37075
    Germany

    Site Not Available

  • Universitat Leipzig Herzzentrum GmbH

    Leipzig, 4103
    Germany

    Site Not Available

  • Universitatsklinikum Ulm

    Ulm, 89081
    Germany

    Site Not Available

  • Universitatsklinikum Koln Klinik I fur Innere Medizin

    Wuerzburg, 97080
    Germany

    Site Not Available

  • Universitatsklinikum Koln Klinik I fur Innere Medizin

    Würzburg 2805615, 97080
    Germany

    Site Not Available

  • ASST Papa Giovanni XXIII

    Bergamo, 24128
    Italy

    Site Not Available

  • ASST Papa Giovanni XXIII

    Bergamo 3182164, 24128
    Italy

    Site Not Available

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

    Bologna, 40138
    Italy

    Site Not Available

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

    Bologna 3181928, 40138
    Italy

    Site Not Available

  • IRCCS Ospedale Policlinico San Martino Padiglione Ex-Isolamento/IST/Padiglione

    Genova, 16132
    Italy

    Site Not Available

  • Fondazione IRCCS - Istituto Nazionale Tumori

    Milan 6951411, 20100
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milan 6951411, 20132
    Italy

    Site Not Available

  • Fondazione IRCCS - Istituto Nazionale Tumori

    Milano, 20100
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, 42123
    Italy

    Site Not Available

  • Arcispedale Santa Maria Nuova

    Reggio Emilia 3169522, 42123
    Italy

    Site Not Available

  • Istituto Clinico Humanitas-IRCCS

    Rozzano, 20089
    Italy

    Site Not Available

  • Istituto Clinico Humanitas-IRCCS

    Rozzano 3168837, 20089
    Italy

    Site Not Available

  • Hyogo Medical University Hospital

    Hyogo, 663-8501
    Japan

    Site Not Available

  • Hyogo Medical University Hospital

    Hyōgo 2129969, 663-8501
    Japan

    Site Not Available

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566,
    Japan

    Site Not Available

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto 1857910, 602-8566,
    Japan

    Site Not Available

  • Tohoku University Hospital

    Miyagi, 980-8574
    Japan

    Site Not Available

  • Tohoku University Hospital

    Miyagi 1856813, 980-8574
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama, 700-8558
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama 1854383, 700-8558
    Japan

    Site Not Available

  • Osaka University Hospital

    Osaka, 565-0871
    Japan

    Site Not Available

  • Osaka University Hospital

    Osaka 1853909, 565-0871
    Japan

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebrón

    Barcelona, 08035
    Spain

    Site Not Available

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

    Barcelona, 08908
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona

    Barcelona 3128760, 08036
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebrón

    Barcelona 3128760, 08035
    Spain

    Site Not Available

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

    Barcelona 3128760, 08908
    Spain

    Site Not Available

  • Hospital 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009
    Spain

    Site Not Available

  • Hospital 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid 3117735, 28009
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca

    Salamanca 3111108, 37007
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia 2509954, 46010
    Spain

    Site Not Available

  • University Hospital Birmingham NHS Foundation Trust

    Birmingham, B15 2GW
    United Kingdom

    Site Not Available

  • University Hospital Birmingham NHS Foundation Trust

    Birmingham 2655603, B15 2GW
    United Kingdom

    Site Not Available

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 2QQ
    United Kingdom

    Site Not Available

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge 2653941, CB2 2QQ
    United Kingdom

    Site Not Available

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • University College London Hospitals NHS Foundation Trust

    London, NW2 2QG
    United Kingdom

    Site Not Available

  • King's College Hospital NHS Foundation Trust

    London 2643743, SE5 9RS
    United Kingdom

    Site Not Available

  • University College London Hospitals NHS Foundation Trust

    London 2643743, NW2 2QG
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • The Christie NHS Foundation Trust

    Manchester 2643123, M20 4BX
    United Kingdom

    Site Not Available

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE
    United Kingdom

    Site Not Available

  • Oxford University Hospitals NHS Foundation Trust

    Oxford 2640729, OX3 7LE
    United Kingdom

    Site Not Available

  • The University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • The University Hospital Southampton NHS Foundation Trust

    Southampton 2637487, SO16 6YD
    United Kingdom

    Site Not Available

  • The Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT
    United Kingdom

    Site Not Available

  • The Royal Marsden NHS Foundation Trust

    Sutton 2636503, SM2 5PT
    United Kingdom

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

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

    Duarte, California 91010
    United States

    Site Not Available

  • UC Irvine Health

    Orange, California 92868
    United States

    Site Not Available

  • Stanford Health Care

    Stanford, California 94305
    United States

    Site Not Available

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

    Duarte 5344147, California 5332921 91010
    United States

    Site Not Available

  • Stanford Health Care

    Stanford 5398563, California 5332921 94305
    United States

    Site Not Available

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Site Not Available

  • Georgetown University Medical Center

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • The University of Kansas Hospital

    Westwood, Kansas 66205
    United States

    Site Not Available

  • The University of Kansas Hospital

    Westwood 4281639, Kansas 4273857 66205
    United States

    Site Not Available

  • University of Kentucky Medical Center

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore 4347778, Maryland 4361885 21201
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Novant Health Cancer Institute Hematology - Charlotte

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Novant Health Cancer Institute Hematology - Charlotte

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Site Not Available

  • Oncology_Hematology Care Clinical Trials, LLC

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Penn State Milton S. Hershey Medical Center

    Hershey 5193342, Pennsylvania 6254927 17033
    United States

    Site Not Available

  • Prisma Health - Upstate

    Greenville, South Carolina 29615
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • Henry-Joyce Cancer Clinic

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • TriStar Centennial Medical Center - Cell Processing

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Henry-Joyce Cancer Clinic

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • TriStar Centennial Medical Center - Cell Processing

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond 4781708, Virginia 6254928 23298
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.