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Recruiting NCT03391778

Adoptive Cell Therapy Long-term Follow-up (LTFU) Study

Phase I Interventional Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ADP adoptive cell therapy.
Who it may be relevant to
Registry conditions: Neoplasms. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Canada, Germany, Italy +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Long-Term Follow-Up (LTFU) of Participants Treated With ADP Adoptive Cell Therapies

Overview

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.

Interventions

  • Biological ADP adoptive cell therapy
    No study drug is administered in this study. Participants who received ADP adoptive cell therapy in a previous trial will be evaluated in this trial for long-term safety and efficacy.

Primary outcome measures

  • Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs) [Time frame: 15 years post last treatment]
Secondary outcome measures (5)
  • Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples [Time frame: 15 years]
  • Number of participants with Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples. [Time frame: 15 years]
  • Number of participants with integrated vector sequences and vector integration patterns identified in peripheral blood samples [Time frame: 15 years]
  • Number of deaths [Time frame: 15 years]
  • Time to death [Time frame: 15 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 13 centers
  • Emory University School of Medicine — Atlanta
  • ADP Investigational Site — Baltimore
  • National Cancer Institute - Center for Cancer Research — Bethesda
  • University of Michigan — Ann Arbor
  • Washington University School of Medicine in St. Louis — St Louis
  • Memorial Sloan Kettering Cancer Center - New York — New York
  • Duke University Medical Center — Durham
  • Oregon Health and Science University — Portland
  • … and 5 more centers
United Kingdom · 3 centers
  • University College London Hospitals NHS Foundation Trust — London
  • USWM CT Investigational Site — Manchester
  • The Royal Marsden NHS Foundation Trust — Sutton
Canada · 2 centers
  • Princess Margaret Cancer Centre — Toronto
  • Hôpital Maisonneuve-Rosemont — Montreal
Germany · 2 centers
  • Klinikum rechts der Isar der Technischen Universität München — Munich
  • Uniklinik Köln — Cologne
Australia · 1 center
  • Peter MacCallum Cancer Centre — Melbourne
Italy · 1 center
  • Fondazione IRCCS - Istituto Nazionale dei Tumori — Milan
Netherlands · 1 center
  • Antoni Van Leeuwenhoek Ziekenhuis — Amsterdam
Spain · 1 center
  • Hospital Universitario Virgen del Rocío — Seville

Identifiers

NCT: NCT03391778 · 208750 · ADP-0000-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗