Clinical trial NCT05371093: Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Relapsed/Refractory Follicular Lymphoma
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2022-05-12
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

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.

Primary outcomes:
measure: Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification
timeFrame: Up to 5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 5 years
measure: Complete Response (CR) Rate as Assessed by Blinded Central Assessment per Lugano Classification
timeFrame: Up to 5 years
measure: Objective Response Rate (ORR) as Assessed by Blinded Central Assessment per Lugano Classification
timeFrame: Up to 5 years
measure: Duration of Response (DOR) as Assessed by Blinded Central Assessment per Lugano Classification
timeFrame: Up to 5 years
measure: Duration of CR as Assessed by Blinded Central Assessment per Lugano Classification
timeFrame: Up to 5 years
measure: Event Free Survival (EFS) as Assessed by Blinded Central Assessment per Lugano Classification
timeFrame: Up to 5 years
measure: Time to Next Treatment (TTNT)
timeFrame: Up to 5 years
measure: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: Randomization up to 5 years plus 30 days
measure: Percentage of Participants Experiencing Clinically Significant Changes in Safety Laboratory Values
timeFrame: Randomization up to 5 years plus 30 days
measure: Percentage of Participants with Replication-competent Retrovirus in Blood Over time
timeFrame: Up to 5 years
measure: Change From Baseline in the Global Health Status Quality of Life Scale of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-30 (EORTC QLQ-C30)
timeFrame: Baseline, up to 5 years
measure: Change From Baseline in the Physical Functioning Domain of the EORTC QLQ-C30
timeFrame: Baseline, up to 5 years
measure: Change From Baseline in the Global Health Status Quality of Life Scale of the Low Grade Non-Hodgkin Lymphoma-20 (NHL-LG20)
timeFrame: Baseline, up to 5 years
measure: Change From Baseline in the Physical Functioning Domain of the NHL-LG20
timeFrame: Baseline, up to 5 years
measure: Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale (EQ-5D-5L)
timeFrame: Baseline, up to 5 years
measure: Changes From Baseline in the Visual Analog Scale (VAS) Scores
timeFrame: Baseline, up to 5 years
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
state: California
city: Stanford
country: United States
facility: Stanford Health Care
state: California
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Westwood
country: United States
facility: The University of Kansas Hospital
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland Greenebaum Comprehensive Cancer Center
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Charlotte
country: United States
facility: Novant Health Cancer Institute Hematology - Charlotte
state: North Carolina
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: TriStar Centennial Medical Center - Cell Processing
state: Tennessee
city: Nashville
country: United States
facility: Henry-Joyce Cancer Clinic
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Créteil
country: France
facility: Hopital Henri Mondor
city: Dijon
country: France
facility: CHU de Dijon
city: Lille cedex
country: France
facility: Hôpital Claude Huriez-CHU de Lille
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Montpellier
country: France
facility: Hopital Saint Eloi
city: Paris
country: France
facility: Hopital Pitie-Salpetriere
city: Pessac
country: France
facility: CHU Bordeaux - Hospital Haut-Leveque - Centre Francois Magendie
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: Hopital Pontchaillou - CHU Rennes
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Göttingen
country: Germany
facility: Universitatsmedizin Gottingen
city: Wuerzburg
country: Germany
facility: Universitatsklinikum Koln Klinik I fur Innere Medizin
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Bologna
country: Italy
facility: Azienda Ospedallero-Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
city: Milano
country: Italy
facility: Fondazione IRCCS - Istituto Nazionale Tumori
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas-IRCCS
city: Hyogo
country: Japan
facility: Hyogo Medical University Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Miyagi
country: Japan
facility: Tohoku University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebrón
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Instituto Catalan de Oncologia - Hospital Duran i Reynolds (ICO L'Hospitalet)
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: The University Hospital Southampton NHS Foundation Trust
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Kite, A Gilead Company
name: Kite Study Director
role: STUDY_DIRECTOR
References: