Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

Solid and Hematological Malignancies Clinical Trial

Official title:

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05041309
• Other study ID #: KT-US-982-5968
• Secondary ID: 2020-005843-21MO
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: December 15, 2021
• Est. completion date: December 2040

Study information

• Verified date: May 2024
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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-222, KITE-363, KITE-439, KITE-585, and KITE-718, in participants of Kite-sponsored interventional studies.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 700
• Est. completion date: December 2040
• Est. primary completion date: December 2040
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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individual must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent, and has discontinued or completed the post-treatment follow-up period in the parent study, as applicable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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Solid and Hematological Malignancies

Intervention

Biological:
• Axicabtagene Ciloleucel
No investigational product will be administered
• Brexucabtagene Autoleucel
No investigational product will be administered
• KITE-585
No investigational product will be administered
• KITE-718
No investigational product will be administered
• KITE-439
No investigational product will be administered
• KITE-222
No investigational product will be administered
• KITE-363
No investigational product will be administered

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Canada	Princess Margaret Cancer Center - University Health Network	Toronto
Canada	Vancouver General Hospital	Vancouver
France	Hopital Saint-Louis	Paris
France	CHU Bordeaux, Hopital Haut-Leveque	Pessac
France	Hôpital Pontchaillou - CHU de Rennes	Rennes
Germany	Universitatsklinikum Carl Gustav Carus	Dresden
Germany	LMU Klinikum der Universitat Munchen,Med. Klinik und Poliklinik III	München
Germany	Universitatsklinikum Wurzburg, Med. Klinik und Poliklinik II, Zentrum lnnere Medizin	Wuerzburg
Israel	Tel Aviv Souraski Medical Center	Tel Aviv
Japan	Kyushu University Hospital	Fukuoka
Japan	Kyoto University Hospital	Kyoto
Japan	Okayama University Hospital	Okayama
Japan	Hokkaido University Hospital	Sapporo Hokkaido
Japan	National Cancer Center Hospital	Tokyo
Netherlands	Amsterdam Universitair Medische Centra (UMC)	Amsterdam
Netherlands	University Medical Centre Groningen	Groningen
Netherlands	Erasmus University Medical Centre (MC)	Rotterdam
Netherlands	UMC Utrecht	Utrecht
United Kingdom	The Royal Marsden NHS Foundation Hospital	London
United States	University of Maryland Greenebaum Comprehensive Cancer Center	Baltimore	Maryland
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	University of Chicago Medical Center Clinical Laboratories	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	James Cancer Hospital and Solove Research Institute	Columbus	Ohio
United States	Colorado Blood Cancer Institute	Denver	Colorado
United States	Karmanos Cancer Center Institute	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	DUHS-Duke Blood Cancer Center	Durham	North Carolina
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	UC San Diego Moores Cancer Center	La Jolla	California
United States	University of California Los Angeles	Los Angeles	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	Sylvester Comprehensive Cancer Centre	Miami	Florida
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Vanderbilt University	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	University of Nebraska	Omaha	Nebraska
United States	Stanford University	Palo Alto	California
United States	Mayo Clinic	Rochester	New York
United States	University of Rochester Medical Center	Rochester	New York
United States	University of California Davis Comprehensive Cancer Center	Sacramento	California
United States	Washington University	Saint Louis	Missouri
United States	University of California, San Francisco Medical Center	San Francisco	California
United States	Fred Hutchinson Cancer Center	Seattle	Washington
United States	Swedish Cancer Institute	Seattle	Washington
United States	Moffitt Cancer Center	Tampa	Florida
United States	The University of Kansas Cancer Center Westwood	Westwood	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Kite, A Gilead Company

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Israel,  Japan,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Experiencing Late-onset Targeted Adverse Events (AEs)	Targeted AEs include late-onset targeted AEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and secondary malignancies.	Up to 15 years
Primary	Percentage of Participants Experiencing Late-onset Targeted Serious Adverse Events (SAEs)	Targeted SAEs include late-onset targeted SAEs suspected to be possibly related to gene-modified cells include neurologic disorders, autoimmune disorders, hematologic disorders, serious infections, and secondary malignancies.	Up to 15 years
Primary	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		Up to 15 years
Primary	Height of Pediatric and Adolescent Participants		Up to 15 years
Primary	Weight of Pediatric and Adolescent Participants		Up to 15 years
Primary	Sexual Maturation of Pediatric and Adolescent Participants Assessed by Tanner Pubertal Stage Scale	The Tanner Pubertal Stage Scale is a measure of pubertal development (sexual maturation) in children and adolescents with components described for each sex, rated separately on a scale of stage one to stage five, with 1 for preadolescent and 5 for mature/adult.	Up to 15 years
Secondary	Time to Subsequent Anticancer Therapies	Time to subsequent anticancer therapies will be assessed only per regulatory request or sponsor needs.	Up to 15 years
Secondary	Survival Status Assessment	Survival status will be assessed as the length of time from the participant's first dose date of study drug to death during the study due to any cause or last date of being alive during the study. Survival status will be assessed only per regulatory request or sponsor needs.	Up to 15 years
Secondary	Cause of Death		Up to 15 years
Secondary	Peripheral B-cell and Lymphocytes Levels for Immune Reconstitution		Up to 15 years
Secondary	Rate of Replication-competent Retrovirus/Replication-competent Lentivirus (RCR/RCL)		Up to 15 years

External Links

•   Gilead Clinical Trials Website