LAST UPDATED
October 15, 2025
Clinicaltrials.gov ID
EudraCT ID
CTSID
OVERVIEW
A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Follicular Lymphoma (ZUMA-22)
PROTOCOL SUMMARY
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Relapsed/Refractory Follicular Lymphoma
Gender
N/A
Date
September 2022 - October 2030
Study Type
Interventional
Study Phase
Phase 3
Product
Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Lenalidomide, Rituximab, Doxorubicin, Vincristine, Prednisone, Bendamustine
Eligibility information
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
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.
Locations
Locations (52)
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States, 91010
The University of Kansas Hospital
Westwood, Kansas, United States, 66205
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Novant Health Cancer Institute Hematology - Charlotte
Charlotte, North Carolina, United States, 28204
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
TriStar Centennial Medical Center - Cell Processing
Nashville, Tennessee, United States, 37203
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie
Pessac, France, 33604
Universitatsklinikum Koln Klinik I fur Innere Medizin
Würzburg, Germany, 97080
Azienda Ospedallero-Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
Bologna, Italy, 40138
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566,
Instituto Catalan de Oncologia - Hospital Duran i Reynolds (ICO L'Hospitalet)
Barcelona, Spain, 08908
University Hospital Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2GW
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 2QQ
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW2 2QG
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 7LE
The University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
The Royal Marsden NHS Foundation Trust
Sutton, United Kingdom, SM2 5PT
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