Clinical trial NCT05041309: Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Official title: Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Solid and Hematological Malignancies
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2021-09-13
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants who received an infusion of gene-modified cells and have not died, withdrawn consent, been withdrawn by the investigator, or been lost to follow-up at the time of transition from the completed parent study.

Brief summary: The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-363, KITE-753, KITE-197, and anitocabtagene autoleucel in participants of Kite-sponsored interventional studies.


Eligibility criteria: Inclusion Criteria:

* The individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable
* The individual must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted
* In the investigator's judgment, the individual is willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation

Exclusion Criteria: none

Primary outcomes:
measure: Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs)
timeFrame: Up to 15 years
measure: Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs)
timeFrame: Up to 15 years
measure: Height of Pediatric and Adolescent Participants
timeFrame: Up to 15 years
measure: Weight of Pediatric and Adolescent Participants
timeFrame: Up to 15 years
measure: Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale Score
timeFrame: Up to 15 years
Secondary outcomes:
measure: Time to Subsequent Anticancer Therapies
timeFrame: Up to 15 years
measure: Survival Status Assessment
timeFrame: Up to 15 years
measure: Percentage of Participants With Cause of Death
timeFrame: Up to 15 years
measure: Overall Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL)
timeFrame: Up to 15 years
measure: Percentage of Participants With Vector Integration Site(s) for Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL) or Insertional Mutagenesis for Confirmed Events Related to the Cell Therapy Product
timeFrame: Up to 15 years
measure: Percentage of Participants With Status of Primary Malignant Disease
timeFrame: Up to 15 years
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Sacramento
country: United States
facility: University of California Davis Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco Medical Center
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Centre
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Ann& Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center Clinical Laboratories
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Westwood
country: United States
facility: The University of Kansas Cancer Center Westwood
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: Detroit
country: United States
facility: Karmanos Cancer Center Institute
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Ichann School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Rochester
country: United States
facility: Mayo Clinic
state: New York
city: Durham
country: United States
facility: DUHS-Duke Blood Cancer Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: James Cancer Hospital and Solove Research Institute
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Sarah Cannon-Methodist Healthcare System - San Antonio
state: Texas
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Innsbruck
country: Austria
facility: Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie und Onkologie
city: Leuven
country: Belgium
facility: UZ Leuven
city: Montreal
country: Canada
facility: McGill University Health Center
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
city: Quebec
country: Canada
facility: Hôpital de l'Enfant-Jésus
city: Toronto
country: Canada
facility: The hospital for sick children
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center - University Health Network
city: Vancouver
country: Canada
facility: Vancouver General Hospital
city: Lille
country: France
facility: Centre Hospitalier Regional Universitaire de Lille
city: Montpellier CEDEX 05
country: France
facility: Hospital Saint Eloi
city: Paris
country: France
facility: Hopital Saint-Louis
city: Pessac
country: France
facility: CHU Bordeaux, Hopital Haut-Leveque
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon-Sud
city: Rennes
country: France
facility: Hôpital Pontchaillou - CHU de Rennes
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Universittsklinikum Heidelberg
city: Mainz
country: Germany
facility: Johannes Gutenberg University Hospital-University Mainz
city: München
country: Germany
facility: LMU Klinikum der Universitat Munchen,Med. Klinik und Poliklinik III
city: Wuerzburg
country: Germany
facility: Universitatsklinikum Wurzburg, Med. Klinik und Poliklinik II, Zentrum lnnere Medizin
city: Tel Aviv
country: Israel
facility: Tel Aviv Souraski Medical Center
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Sapporo Hokkaido
country: Japan
facility: Hokkaido University Hospital
city: Tokyo
country: Japan
facility: National Cancer Center Hospital
city: Amsterdam
country: Netherlands
facility: Amsterdam Universitair Medische Centra (UMC)
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Centre (MC)
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Institut Catalia d'Oncologia L'Hospitalet
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Bellinzona
country: Switzerland
facility: Istituto Oncologico Della Svizzera Italiana (IOSI)
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Hospital
Study officials:
affiliation: Kite, A Gilead Company
name: Kite Study Director
role: STUDY_DIRECTOR
References: