Study Details

Participation Requirements

Age

18 Years +

Sex

ALL

Healthy Volunteers

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 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

Stanford Health Care

Stanford, California, United States, 94305

Moffitt Cancer Center

Tampa, Florida, United States, 33612

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

Henry-Joyce Cancer Clinic

Nashville, Tennessee, United States, 37232

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Hopital Henri Mondor

Créteil, France, 94010

CHU de Dijon

Dijon, France, 21079

Hôpital Claude Huriez-CHU de Lille

Lille cedex, France, 59037

Institut Paoli-Calmettes

Marseille, France, 13273

Hopital Saint Eloi

Montpellier, France, 34295

Hopital Pitie-Salpetriere

Paris, France, 75013

CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie

Pessac, France, 33604

Centre Hospitalier Lyon Sud

Pierre Benite, France, 69495

CHU de Poitiers

Poitiers, France, 86021

Hopital Pontchaillou - CHU Rennes

Rennes, France, 35033

Centre Henri Becquerel

Rouen, France, 76038

Universitatsmedizin Gottingen

Göttingen, Germany, 37075

Universitatsklinikum Koln Klinik I fur Innere Medizin

Wuerzburg, Germany, 97080

ASST Papa Giovanni XXIII

Bergamo, Italy, 24128

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

Bologna, Italy, 40138

Fondazione IRCCS - Istituto Nazionale Tumori

Milano, Italy, 20100

Ospedale San Raffaele

Milano, Italy, 20132

Arcispedale Santa Maria Nuova

Reggio Emilia, Italy, 42123

Istituto Clinico Humanitas-IRCCS

Rozzano, Italy, 20089

Hyogo Medical University Hospital

Hyogo, Japan, 663-8501

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Japan, 602-8566,

Tohoku University Hospital

Miyagi, Japan, 980-8574

Okayama University Hospital

Okayama, Japan, 700-8558

Osaka University Hospital

Osaka, Japan, 565-0871

Hospital Universitari Vall d'Hebrón

Barcelona, Spain, 08035

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

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

Barcelona, Spain, 08908

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28009

Hospital 12 de Octubre

Madrid, Spain, 28041

Hospital Universitario de Salamanca

Salamanca, Spain, 37007

Hospital Universitario Virgen del Rocio

Sevilla, Spain, 41013

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

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

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

OVERVIEW

PROTOCOL SUMMARY