Non Hodgkin Lymphoma Clinical Trial

Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

Summary

The primary objective of this study is to determine if axicabtagene ciloleucel is superior to standard of care therapy (SOCT), as measured by progression-free survival (PFS) in participants with relapsed/refractory follicular lymphoma.

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Full Description

Five years after the last study participant is randomized, participants who have received axicabtagene ciloleucel will transition to a separate Long-term Follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

View Eligibility Criteria

Eligibility Criteria

Key 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

Key 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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

230

Study ID:

NCT05371093

Recruitment Status:

Recruiting

Sponsor:

Kite, A Gilead Company

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There are 69 Locations for this study

See Locations Near You

University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte California, 91010, United States
UC Irvine Health
Orange California, 92868, United States
Stanford Health Care
Stanford California, 94305, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
The University of Kansas Hospital
Westwood Kansas, 66205, United States
University of Kentucky Medical Center
Lexington Kentucky, 40536, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore Maryland, 21201, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Columbia University Irving Medical Center
New York New York, 10032, United States
Novant Health Cancer Institute Hematology - Charlotte
Charlotte North Carolina, 28204, United States
Oncology_Hematology Care Clinical Trials, LLC
Cincinnati Ohio, 45242, United States
Penn State Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Prisma Health - Upstate
Greenville South Carolina, 29615, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, 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 Oncology Associates
Norfolk Virginia, 23502, 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 cedex , 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 Benite , 69495, France
CHU de Poitiers
Poitiers , 86021, France
Hopital Pontchaillou - CHU Rennes
Rennes , 35033, France
Centre Henri Becquerel
Rouen , 76038, France
Helios Klinikum Berlin-Buch
Berlin , 13125, Germany
Universitatsklinikum Koln Klinik I fur Innere Medizin
Cologne , 50937, Germany
Universitatsmedizin Gottingen
Göttingen , 37075, Germany
Universitat Leipzig Herzzentrum GmbH
Leipzig , 4103, Germany
Universitatsklinikum Ulm
Ulm , 89081, Germany
Universitatsklinikum Koln Klinik I fur Innere Medizin
Wuerzburg , 97080, Germany
ASST Papa Giovanni XXIII
Bergamo , 24128, Italy
Azienda Ospedallero-Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
Bologna , 40138, Italy
IRCCS Ospedale Policlinico San Martino Padiglione Ex-Isolamento/IST/Padiglione
Genova , 16132, Italy
Fondazione IRCCS - Istituto Nazionale Tumori
Milano , 20100, Italy
Ospedale San Raffaele
Milano , 20132, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia , 42123, Italy
Istituto Clinico Humanitas-IRCCS
Rozzano , 20089, Italy
Hyogo Medical University Hospital
Hyogo , 663-8, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto , 602-8, Japan
Tohoku University Hospital
Miyagi , 980-8, Japan
Okayama University Hospital
Okayama , 700-8, Japan
Osaka University Hospital
Osaka , 565-0, 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
Sevilla , 41013, Spain
Hospital Clínico Universitario de Valencia
Valencia , 46010, Spain
University Hospital Birmingham NHS Foundation Trust
Birmingham , B15 2, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge , CB2 2, United Kingdom
University College London Hospitals NHS Foundation Trust
London , NW3 2, United Kingdom
King's College Hospital NHS Foundation Trust
London , SE5 9, United Kingdom
The Christie NHS Foundation Trust
Manchester , M20 4, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford , OX3 7, United Kingdom
The University Hospital Southampton NHS Foundation Trust
Southampton , SO16 , United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

230

Study ID:

NCT05371093

Recruitment Status:

Recruiting

Sponsor:


Kite, A Gilead Company

How clear is this clinincal trial information?

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