Clinical trial
Phase 3
Interventional
Ages 18 and up
Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma
Run by Kite, A Gilead Company · NCT05371093 · Data updated 2026-11-12
Fully enrolled, still running. This study is not taking new participants. Its registered completion date is 2030-10.
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 231 (actual) |
| Sponsor | Kite, A Gilead Company Industry-sponsored |
| Drugs / interventions | Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Lenalidomide, Rituximab, Doxorubicin, Vincristine, Prednisone, Bendamustine |
| Locations | 52 sites (France, Germany, Italy, Japan, Spain, United Kingdom, United States) |
| Trial ID | NCT05371093 on ClinicalTrials.gov |
What this trial studies
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.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria:
* Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)
* Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r disease after ≥ 2 prior systemic lines of therapy
* Clinical indication for treatment.
* At least 1 measurable lesion per the Lugano Classification {Cheson 2014}
* Adequate renal, hepatic, pulmonary, and cardiac function
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 C virus
* 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/pericardial catheter, or Ommaya reservoirs). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheter are permitted.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Where it's running
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City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States -
Stanford Health Care
Stanford, California, United States -
Moffitt Cancer Center
Tampa, Florida, United States -
The University of Kansas Hospital
Westwood, Kansas, United States -
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States -
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Show 44 more locations
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Novant Health Cancer Institute Hematology - Charlotte
Charlotte, North Carolina, United States -
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States -
TriStar Centennial Medical Center - Cell Processing
Nashville, Tennessee, United States -
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States -
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States -
Virginia Commonwealth University
Richmond, Virginia, United States -
Hopital Henri Mondor
Créteil, France -
CHU de Dijon
Dijon, France -
Hôpital Claude Huriez-CHU de Lille
Lille, France -
Institut Paoli-Calmettes
Marseille, France -
Hopital Saint Eloi
Montpellier, France -
Hopital Pitie-Salpetriere
Paris, France -
CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie
Pessac, France -
Centre Hospitalier Lyon Sud
Pierre-Bénite, France -
CHU de Poitiers
Poitiers, France -
Hopital Pontchaillou - CHU Rennes
Rennes, France -
Centre Henri Becquerel
Rouen, France -
Universitatsmedizin Gottingen
Göttingen, Germany -
Universitatsklinikum Koln Klinik I fur Innere Medizin
Würzburg, Germany -
ASST Papa Giovanni XXIII
Bergamo, Italy -
Azienda Ospedallero-Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
Bologna, Italy -
Fondazione IRCCS - Istituto Nazionale Tumori
Milan, Italy -
Ospedale San Raffaele
Milan, Italy -
Arcispedale Santa Maria Nuova
Reggio Emilia, Italy -
Istituto Clinico Humanitas-IRCCS
Rozzano, Italy -
Hyogo Medical University Hospital
Hyōgo, Japan -
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Japan -
Tohoku University Hospital
Miyagi, Japan -
Okayama University Hospital
Okayama, Japan -
Osaka University Hospital
Osaka, Japan -
Hospital Universitari Vall d'Hebrón
Barcelona, Spain -
Hospital Clinic de Barcelona
Barcelona, Spain -
Instituto Catalan de Oncologia - Hospital Duran i Reynolds (ICO L'Hospitalet)
Barcelona, Spain -
Hospital General Universitario Gregorio Maranon
Madrid, Spain -
Hospital 12 de Octubre
Madrid, Spain -
Hospital Universitario de Salamanca
Salamanca, Spain -
Hospital Universitario Virgen del Rocio
Seville, Spain -
Hospital Clínico Universitario de Valencia
Valencia, Spain -
University Hospital Birmingham NHS Foundation Trust
Birmingham, United Kingdom -
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom -
University College London Hospitals NHS Foundation Trust
London, United Kingdom -
King's College Hospital NHS Foundation Trust
London, United Kingdom -
The Christie NHS Foundation Trust
Manchester, United Kingdom -
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
+2 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Kite Study Director — Kite, A Gilead Company
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-15 by the Find a Trial editorial team.
Information on this page is for educational purposes and is not medical advice.
Always consult qualified healthcare professionals about clinical trial participation.