Clinical trial NCT03391778: Adoptive Cell Therapy Long-term Follow-up (LTFU) Study
Official title: Long-Term Follow-Up (LTFU) of Participants Treated With ADP Adoptive Cell Therapies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Neoplasms
Keywords: Long Term Follow Up
Adoptive Cell Therapy
Replication Competent Lentivirus
Lead sponsor: Adaptimmune
Sponsor class: INDUSTRY
First posted: 2018-01-05
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This trial will evaluate long term safety of participants who have received AdaptImmune (ADP) adoptive cell therapy for up to 15 years following last adoptive cell therapy infusion.

Detailed description: Participants who received a ADP adoptive cell therapy will be enrolled in this non-therapeutic, multi-center, long term follow-up (LTFU) study and will be followed for up to 15 years post-infusion of lentiviral vector-based adoptive cell therapy. Participants will be monitored for safety following last adoptive cell therapy infusion.

Eligibility criteria: Inclusion Criteria:

* Participants who have received at least one dose of ADP adoptive cell therapy agent.
* Participants who have completed ADP sponsored or supported interventional study or have withdrawn from it.
* Participants who have completed treatment as part of managed access to a GSK adoptive cell therapy.
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* The investigator is responsible for review of medical history.
* Capable of giving signed informed consent.

Exclusion Criteria:

- None

Primary outcomes:
measure: Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs)
timeFrame: 15 years post last treatment
Secondary outcomes:
measure: Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples
timeFrame: 15 years
measure: Number of participants with Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples.
timeFrame: 15 years
measure: Number of participants with integrated vector sequences and vector integration patterns identified in peripheral blood samples
timeFrame: 15 years
measure: Number of deaths
timeFrame: 15 years
measure: Time to death
timeFrame: 15 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Baltimore
country: United States
facility: ADP Investigational Site
state: Maryland
city: Bethesda
country: United States
facility: National Cancer Institute - Center for Cancer Research
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center - New York
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Milwaukee
country: United States
facility: Froedtert Hospital
state: Wisconsin
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München
state: Bayern
city: Koeln
country: Germany
facility: Uniklinik Köln
state: Nordrhein-Westfalen
city: Milano
country: Italy
facility: Fondazione IRCCS - Istituto Nazionale dei Tumori
state: Lombardia
city: Amsterdam
country: Netherlands
facility: Antoni Van Leeuwenhoek Ziekenhuis
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: ADP Investigational Site
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Adaptimmune
name: Adaptimmune
role: STUDY_DIRECTOR
References: