The content of this website is intended for United States audiences only.

Report an Adverse Event
/-/media/project/gileadclinicaltrial/header/arrow-right-img.svg
Back Arrow Back to search results
Global Share

STATUS Recruiting

Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma (ZUMA-22)

LAST UPDATED

March 26 2025

Clinicaltrials.gov ID

NCT05371093

CTSID

2021-003260-28

CTSID

2024-511594-30

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 More

Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

Relapsed/Refractory Follicular Lymphoma

Gender

N/A

Date

September 2022 - October 2030

Study Type

INTERVENTIONAL

Study Phase

PHASE3

Product

Axicabtagene Ciloleucel, Cyclophosphamide, Fludarabine, Lenalidomide, Rituximab, Doxorubicin, Vincristine, Prednisone, Bendamustine

Eligibility Information

Inclusion

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
VIEW MORE
Exclusion

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.
VIEW MORE

Locations

Locations (69)
Withdrawn

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

Recruitment Complete

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

Duarte, California, United States, 91010

Withdrawn

UC Irvine Health

Orange, California, United States, 92868

Recruitment Complete

Stanford Health Care

Stanford, California, United States, 94305

Withdrawn

Colorado Blood Cancer Institute

Denver, Colorado, United States, 80218

Withdrawn

Georgetown University Medical Center

Washington, District of Columbia, United States, 20007

Recruitment Complete

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Recruitment Complete

The University of Kansas Hospital

Westwood, Kansas, United States, 66205

Withdrawn

University of Kentucky Medical Center

Lexington, Kentucky, United States, 40536

Recruitment Complete

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States, 21201

Recruitment Complete

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Withdrawn

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

Withdrawn

Columbia University Irving Medical Center

New York, New York, United States, 10032

Recruitment Complete

Novant Health Cancer Institute Hematology - Charlotte

Charlotte, North Carolina, United States, 28204

Withdrawn

Oncology_Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, United States, 45242

Recruitment Complete

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Withdrawn

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

Withdrawn

Prisma Health - Upstate

Greenville, South Carolina, United States, 29615

Withdrawn

Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105

Recruitment Complete

TriStar Centennial Medical Center - Cell Processing

Nashville, Tennessee, United States, 37203

Recruitment Complete

Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States, 37232

Recruitment Complete

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Withdrawn

Virginia Oncology Associates

Norfolk, Virginia, United States, 23502

Recruitment Complete

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Recruitment Complete

Hopital Henri Mondor

Créteil, France, 94010

Recruitment Complete

CHU de Dijon

Dijon, France, 21079

Recruitment Complete

Hôpital Claude Huriez-CHU de Lille

Lille cedex, France, 59037

Recruitment Complete

Institut Paoli-Calmettes

Marseille, France, 13273

Recruitment Complete

Hopital Saint Eloi

Montpellier, France, 34295

Recruitment Complete

Hopital Pitie-Salpetriere

Paris, France, 75013

Recruitment Complete

CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie

Pessac, France, 33604

Recruitment Complete

Centre Hospitalier Lyon Sud

Pierre Benite, France, 69495

Recruitment Complete

CHU de Poitiers

Poitiers, France, 86021

Recruitment Complete

Hopital Pontchaillou - CHU Rennes

Rennes, France, 35033

Recruitment Complete

Centre Henri Becquerel

Rouen, France, 76038

Withdrawn

Helios Klinikum Berlin-Buch

Berlin, Germany, 13125

Withdrawn

Universitatsklinikum Koln Klinik I fur Innere Medizin

Cologne, Germany, 50937

Recruitment Complete

Universitatsmedizin Gottingen

Göttingen, Germany, 37075

Withdrawn

Universitat Leipzig Herzzentrum GmbH

Leipzig, Germany, 4103

Withdrawn

Universitatsklinikum Ulm

Ulm, Germany, 89081

Recruitment Complete

Universitatsklinikum Koln Klinik I fur Innere Medizin

Wuerzburg, Germany, 97080

Recruitment Complete

ASST Papa Giovanni XXIII

Bergamo, Italy, 24128

Recruitment Complete

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

Bologna, Italy, 40138

Withdrawn

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

Genova, Italy, 16132

Recruitment Complete

Fondazione IRCCS - Istituto Nazionale Tumori

Milano, Italy, 20100

Recruitment Complete

Ospedale San Raffaele

Milano, Italy, 20132

Recruitment Complete

Arcispedale Santa Maria Nuova

Reggio Emilia, Italy, 42123

Recruitment Complete

Istituto Clinico Humanitas-IRCCS

Rozzano, Italy, 20089

Recruiting

Hyogo Medical University Hospital

Hyogo, Japan, 663-8501

Recruiting

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Japan, 602-8566,

Recruiting

Tohoku University Hospital

Miyagi, Japan, 980-8574

Recruiting

Okayama University Hospital

Okayama, Japan, 700-8558

Recruiting

Osaka University Hospital

Osaka, Japan, 565-0871

Recruitment Complete

Hospital Universitari Vall d'Hebrón

Barcelona, Spain, 08035

Recruitment Complete

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Recruitment Complete

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

Barcelona, Spain, 08908

Recruitment Complete

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28009

Recruitment Complete

Hospital 12 de Octubre

Madrid, Spain, 28041

Recruitment Complete

Hospital Universitario de Salamanca

Salamanca, Spain, 37007

Recruitment Complete

Hospital Universitario Virgen del Rocio

Sevilla, Spain, 41013

Recruitment Complete

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Recruitment Complete

University Hospital Birmingham NHS Foundation Trust

Birmingham, United Kingdom, B15 2GW

Recruitment Complete

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom, CB2 2QQ

Recruitment Complete

University College London Hospitals NHS Foundation Trust

London, United Kingdom, NW2 2QG

Recruitment Complete

King's College Hospital NHS Foundation Trust

London, United Kingdom, SE5 9RS

Recruitment Complete

The Christie NHS Foundation Trust

Manchester, United Kingdom, M20 4BX

Recruitment Complete

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom, OX3 7LE

Recruitment Complete

The University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom, SO16 6YD

Recruitment Complete

The Royal Marsden NHS Foundation Trust

Sutton, United Kingdom, SM2 5PT