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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT03391778

Studienbeginn:
April 2018

Letztes Update:
28.02.2024

Wirkstoff:
GSK adoptive cell therapy

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 1

Sponsor:
GlaxoSmithKline

Collaborator:
-

Studienleiter

GSK Clinical Trials
Study Director
GlaxoSmithKline

Kontakt

EU GSK Clinical Trials Call Center
Kontakt:
Phone: +44 (0) 20 89904466
E-Mail: GSKClinicalSupportHD@gsk.com» Kontaktdaten anzeigen

Studienlocations
(3 von 29)

GSK Investigational Site
81377 Muenchen
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
50937 Koeln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
33612 Tampa
United StatesAbgeschlossen» Google-Maps
GSK Investigational Site
30322 Atlanta
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
21201 Baltimore
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
20892 Bethesda
United StatesAbgeschlossen» Google-Maps
GSK Investigational Site
02215 Boston
United StatesAbgeschlossen» Google-Maps
GSK Investigational Site
48109 Ann Arbor
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
10065 New York
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
27710 Durham
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
97239 Portland
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
19104 Philadelphia
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
15232 Pittsburgh
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
75235 Dallas
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
77030 Houston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
53226 Milwaukee
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
3000 Melbourne
AustraliaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
M5G 2M9 Toronto
CanadaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
H1T 2M4 Montreal
CanadaRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
20133 Milano
ItalyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
1066 CX Amsterdam
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
08035 Barcelona
SpainRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
28040 Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
28050 Madrid
SpainRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
41013 Sevilla
SpainRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
NW1 2PG London
United KingdomRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
M20 4BX Manchester
United KingdomRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
SM2 5PT Sutton
United KingdomRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

Participants who received a GSK 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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Participants who have received at least one dose of GSK adoptive cell therapy agent.

- Participants who have completed GSK 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

Studien-Rationale

Primary outcome:

1. Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs) (Time Frame - 15 years post last treatment):
AEs will be collected.



Secondary outcome:

1. Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples (Time Frame - 15 years):
Peripheral blood samples will be collected for the assessment of VSV-G DNA copies.

2. Number of participants with Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples. (Time Frame - 15 years):
Peripheral blood samples will be collected for the assessment of WPRE or Psi DNA.

3. Number of participants with integrated vector sequences and vector integration patterns identified in peripheral blood samples (Time Frame - 15 years):
Peripheral blood samples will be collected for the assessment of Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal).

4. Number of deaths (Time Frame - 15 years):
Number of deaths will be summarized.

5. Time to death (Time Frame - 15 years):
Time to death will be summarized.

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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