Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma
ZUMA-22
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
3 other identifiers
interventional
231
7 countries
52
Brief Summary
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2022
Longer than P75 for phase_3
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2022
CompletedFirst Posted
Study publicly available on registry
May 12, 2022
CompletedStudy Start
First participant enrolled
September 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2030
October 15, 2025
October 1, 2025
8 years
May 9, 2022
October 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification
PFS is defined as the time from randomization to disease progression or death due to any cause.
Up to 5 years
Secondary Outcomes (16)
Overall Survival (OS)
Up to 5 years
Complete Response (CR) Rate as Assessed by Blinded Central Assessment per Lugano Classification
Up to 5 years
Objective Response Rate (ORR) as Assessed by Blinded Central Assessment per Lugano Classification
Up to 5 years
Duration of Response (DOR) as Assessed by Blinded Central Assessment per Lugano Classification
Up to 5 years
Duration of CR as Assessed by Blinded Central Assessment per Lugano Classification
Up to 5 years
- +11 more secondary outcomes
Study Arms (2)
Axicabtagene Ciloleucel
EXPERIMENTALParticipants will receive cyclophosphamide 500 mg/m\^2/day intravenously (IV) and fludarabine 30 mg/m\^2/day IV lymphodepleting chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10\^8 anti-CD19 CAR T cells will be administered.
Standard of Care Therapy
ACTIVE COMPARATORParticipants will receive the investigator's choice of one of the following therapies/dosing schedules: * Rituximab plus lenalidomide (R\^2) for 12 cycles (28-day cycle) * Cycle 1: lenalidomide 20 mg/day on Day 1 through Day 21; rituximab 375 mg/m\^2 on Day 1, Day 8, Day 15, and Day 22 * Cycle 2 through Cycle 5: lenalidomide 20 mg/day on Day 1 through Day 21; Rituximab 375 mg/m2 on Day 1 * Cycle 6 through Cycle 12: lenalidomide 20 mg/day on Day 1 through Day 21 * Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 6 cycles (21-day cycle) * rituximab 375 mg/m\^2 on Day 1 * cyclophosphamide 750 mg/m\^2 on Day 1 * doxorubicin 50 mg/m\^2 on Day 1 * vincristine 1.4 mg/m\^2 (maximum 2 mg) on Day 1 * prednisone 40 mg/m\^2 on Day 1 through Day 5 * Rituximab plus bendamustine (BR) for 6 cycles (28-day cycle) * rituximab 375 mg/m\^2 on Day 1 * bendamustine 90 mg/m\^2 on Day 1 and Day 2
Interventions
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, 91010, United States
Stanford Health Care
Stanford, California, 94305, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
The University of Kansas Hospital
Westwood, Kansas, 66205, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Novant Health Cancer Institute Hematology - Charlotte
Charlotte, North Carolina, 28204, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
TriStar Centennial Medical Center - Cell Processing
Nashville, Tennessee, 37203, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Hopital Henri Mondor
Créteil, 94010, France
CHU de Dijon
Dijon, 21079, France
Hôpital Claude Huriez-CHU de Lille
Lille, 59037, France
Institut Paoli-Calmettes
Marseille, 13273, France
Hopital Saint Eloi
Montpellier, 34295, France
Hopital Pitie-Salpetriere
Paris, 75013, France
CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie
Pessac, 33604, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU de Poitiers
Poitiers, 86021, France
Hopital Pontchaillou - CHU Rennes
Rennes, 35033, France
Centre Henri Becquerel
Rouen, 76038, France
Universitatsmedizin Gottingen
Göttingen, 37075, Germany
Universitatsklinikum Koln Klinik I fur Innere Medizin
Würzburg, 97080, Germany
ASST Papa Giovanni XXIII
Bergamo, 24128, Italy
Azienda Ospedallero-Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
Bologna, 40138, Italy
Fondazione IRCCS - Istituto Nazionale Tumori
Milan, 20100, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, 42123, Italy
Istituto Clinico Humanitas-IRCCS
Rozzano, 20089, Italy
Hyogo Medical University Hospital
Hyōgo, 663-8501, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566,, Japan
Tohoku University Hospital
Miyagi, 980-8574, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Osaka University Hospital
Osaka, 565-0871, Japan
Hospital Universitari Vall d'Hebrón
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynolds (ICO L'Hospitalet)
Barcelona, 08908, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28009, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
University Hospital Birmingham NHS Foundation Trust
Birmingham, B15 2GW, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 2QQ, United Kingdom
University College London Hospitals NHS Foundation Trust
London, NW2 2QG, United Kingdom
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE, United Kingdom
The University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kite Study Director
Kite, A Gilead Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2022
First Posted
May 12, 2022
Study Start
September 22, 2022
Primary Completion (Estimated)
October 1, 2030
Study Completion (Estimated)
October 1, 2030
Last Updated
October 15, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share