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STATUS Recruiting

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

LAST UPDATED

April 30, 2024

Clinicaltrials.gov ID

NCT05371093

CTIS ID

2021-003260-28

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

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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

Phase 3

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
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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.
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Locations

Locations (69)
Recruiting

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

Recruiting

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

Duarte, California, United States, 91010

Recruiting

UC Irvine Health

Orange, California, United States, 92868

Recruiting

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

Recruiting

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Recruiting

The University of Kansas Hospital

Westwood, Kansas, United States, 66205

Recruiting

University of Kentucky Medical Center

Lexington, Kentucky, United States, 40536

Recruiting

University of Maryland Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, United States, 21201

Recruiting

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

Recruiting

Columbia University Irving Medical Center

New York, New York, United States, 10032

Recruiting

Novant Health Cancer Institute Hematology - Charlotte

Charlotte, North Carolina, United States, 28204

Recruiting

Oncology_Hematology Care Clinical Trials, LLC

Cincinnati, Ohio, United States, 45242

Recruiting

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Withdrawn

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

Recruiting

Prisma Health - Upstate

Greenville, South Carolina, United States, 29615

Withdrawn

Avera Cancer Institute

Sioux Falls, South Dakota, United States, 57105

Recruiting

TriStar Centennial Medical Center - Cell Processing

Nashville, Tennessee, United States, 37203

Will Be Recruiting

Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States, 37232

Recruiting

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Recruiting

Virginia Oncology Associates

Norfolk, Virginia, United States, 23502

Will Be Recruiting

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Recruiting

Hopital Henri Mondor

Créteil, France, 94010

Recruiting

CHU de Dijon

Dijon, France, 21079

Recruiting

Hôpital Claude Huriez-CHU de Lille

Lille cedex, France, 59037

Recruiting

Institut Paoli-Calmettes

Marseille, France, 13273

Recruiting

Hopital Saint Eloi

Montpellier, France, 34295

Recruiting

Hopital Pitie-Salpetriere

Paris, France, 75013

Recruiting

CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie

Pessac, France, 33604

Recruiting

Centre Hospitalier Lyon Sud

Pierre Benite, France, 69495

Recruiting

CHU de Poitiers

Poitiers, France, 86021

Recruiting

Hopital Pontchaillou - CHU Rennes

Rennes, France, 35033

Recruiting

Centre Henri Becquerel

Rouen, France, 76038

Recruiting

Helios Klinikum Berlin-Buch

Berlin, Germany, 13125

Recruiting

Universitatsklinikum Koln Klinik I fur Innere Medizin

Cologne, Germany, 50937

Recruiting

Universitatsmedizin Gottingen

Göttingen, Germany, 37075

Recruiting

Universitat Leipzig Herzzentrum GmbH

Leipzig, Germany, 4103

Recruiting

Universitatsklinikum Ulm

Ulm, Germany, 89081

Recruiting

Universitatsklinikum Koln Klinik I fur Innere Medizin

Wuerzburg, Germany, 97080

Recruiting

ASST Papa Giovanni XXIII

Bergamo, Italy, 24128

Recruiting

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

Bologna, Italy, 40138

Recruiting

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

Genova, Italy, 16132

Recruiting

Fondazione IRCCS - Istituto Nazionale Tumori

Milano, Italy, 20100

Recruiting

Ospedale San Raffaele

Milano, Italy, 20132

Recruiting

Arcispedale Santa Maria Nuova

Reggio Emilia, Italy, 42123

Recruiting

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

Recruiting

Hospital Universitari Vall d'Hebrón

Barcelona, Spain, 08035

Recruiting

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Recruiting

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

Barcelona, Spain, 08908

Recruiting

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28009

Recruiting

Hospital 12 de Octubre

Madrid, Spain, 28041

Recruiting

Hospital Universitario de Salamanca

Salamanca, Spain, 37007

Recruiting

Hospital Universitario Virgen del Rocio

Sevilla, Spain, 41013

Recruiting

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Recruiting

University Hospital Birmingham NHS Foundation Trust

Birmingham, United Kingdom, B15 2GW

Recruiting

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom, CB2 2QQ

Recruiting

University College London Hospitals NHS Foundation Trust

London, United Kingdom, NW3 2QG

Recruiting

King's College Hospital NHS Foundation Trust

London, United Kingdom, SE5 9RS

Recruiting

The Christie NHS Foundation Trust

Manchester, United Kingdom, M20 4BX

Recruiting

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom, OX3 7LE

Recruiting

The University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom, SO16 6YD

Recruiting

The Royal Marsden NHS Foundation Trust

Sutton, United Kingdom, SM2 5PT