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

Last updated: May 7, 2025
Sponsor: Kite, A Gilead Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Lymphoma

Follicular Lymphoma

Treatment

Prednisone

Bendamustine

Fludarabine

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: 230
Treatment Group(s): 9
Primary Treatment: Prednisone
Phase: 3
Study Start date:
September 12, 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

  • CHU de Dijon

    Dijon, 21079
    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

  • Hopital Saint Eloi

    Montpellier, 34295
    France

    Site Not Available

  • Hopital Pitie-Salpetriere

    Paris, 75013
    France

    Site Not Available

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

    Pessac, 33604
    France

    Site Not Available

  • Centre Hospitalier Lyon Sud

    Pierre Benite, 69495
    France

    Site Not Available

  • CHU de Poitiers

    Poitiers, 86021
    France

    Site Not Available

  • Hopital Pontchaillou - CHU Rennes

    Rennes, 35033
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen, 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

  • 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

  • ASST Papa Giovanni XXIII

    Bergamo, 24128
    Italy

    Site Not Available

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

    Bologna, 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

    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

  • Istituto Clinico Humanitas-IRCCS

    Rozzano, 20089
    Italy

    Site Not Available

  • Hyogo Medical University Hospital

    Hyogo, 663-8501
    Japan

    Site Not Available

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566,
    Japan

    Site Not Available

  • Tohoku University Hospital

    Miyagi, 980-8574
    Japan

    Site Not Available

  • Okayama University Hospital

    Okayama, 700-8558
    Japan

    Site Not Available

  • Osaka University Hospital

    Osaka, 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 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009
    Spain

    Site Not Available

  • Hospital Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • University Hospital Birmingham NHS Foundation Trust

    Birmingham, B15 2GW
    United Kingdom

    Site Not Available

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, 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

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE
    United Kingdom

    Site Not Available

  • The University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • The Royal Marsden NHS Foundation Trust

    Sutton, 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

  • 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

  • The University of Kansas Hospital

    Westwood, Kansas 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

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 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

  • 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

  • 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

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 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

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