Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma
NCT ID: NCT05371093
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
231 participants
INTERVENTIONAL
2022-09-22
2030-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Axicabtagene Ciloleucel
Participants 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.
Axicabtagene Ciloleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Cyclophosphamide
Administered intravenously
Fludarabine
Administered intravenously
Standard of Care Therapy
Participants 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
Cyclophosphamide
Administered intravenously
Lenalidomide
Administered orally
Rituximab
Administered intravenously
Doxorubicin
Administered intravenously
Vincristine
Administered intravenously
Prednisone
Administered orally
Bendamustine
Administered intravenously
Interventions
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Axicabtagene Ciloleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Cyclophosphamide
Administered intravenously
Fludarabine
Administered intravenously
Lenalidomide
Administered orally
Rituximab
Administered intravenously
Doxorubicin
Administered intravenously
Vincristine
Administered intravenously
Prednisone
Administered orally
Bendamustine
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Kite, A Gilead Company
INDUSTRY
Responsible Party
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Principal Investigators
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Kite Study Director
Role: STUDY_DIRECTOR
Kite, A Gilead Company
Locations
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City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
Stanford Health Care
Stanford, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
The University of Kansas Hospital
Westwood, Kansas, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Novant Health Cancer Institute Hematology - Charlotte
Charlotte, North Carolina, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
TriStar Centennial Medical Center - Cell Processing
Nashville, Tennessee, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Hopital Henri Mondor
Créteil, , France
CHU de Dijon
Dijon, , France
Hôpital Claude Huriez-CHU de Lille
Lille, , France
Institut Paoli-Calmettes
Marseille, , France
Hopital Saint Eloi
Montpellier, , France
Hopital Pitie-Salpetriere
Paris, , France
CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie
Pessac, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU de Poitiers
Poitiers, , France
Hopital Pontchaillou - CHU Rennes
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Universitatsmedizin Gottingen
Göttingen, , Germany
Universitatsklinikum Koln Klinik I fur Innere Medizin
Würzburg, , Germany
ASST Papa Giovanni XXIII
Bergamo, , Italy
Azienda Ospedallero-Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
Bologna, , Italy
Fondazione IRCCS - Istituto Nazionale Tumori
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, , Italy
Istituto Clinico Humanitas-IRCCS
Rozzano, , Italy
Hyogo Medical University Hospital
Hyōgo, , Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, , Japan
Tohoku University Hospital
Miyagi, , Japan
Okayama University Hospital
Okayama, , Japan
Osaka University Hospital
Osaka, , Japan
Hospital Universitari Vall d'Hebrón
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynolds (ICO L'Hospitalet)
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
University Hospital Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
The University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Countries
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Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2021-003260-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-511594-30
Identifier Type: OTHER
Identifier Source: secondary_id
KT-US-473-0133
Identifier Type: -
Identifier Source: org_study_id
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