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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03391778
Collaborator
(none)
250
Enrollment
38
Locations
1
Arm
167.8
Anticipated Duration (Months)
6.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial will evaluate long term safety of participants who have received GlaxoSmithKline (GSK) adoptive cell therapy for up to 15 years following last adoptive cell therapy infusion.

Condition or Disease Intervention/Treatment Phase
  • Biological: GSK adoptive cell therapy
 Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Long-Term Follow-Up (LTFU) of Participants Treated With GSK Adoptive Cell Therapies
Actual Study Start Date :
Apr 9, 2018
Anticipated Primary Completion Date :
Apr 1, 2032
Anticipated Study Completion Date :
Apr 1, 2032

Arms and Interventions

Arm Intervention/Treatment
Experimental: Participants receiving GSK adoptive cell therapy

Biological: 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.

Outcome Measures

Primary Outcome Measures

  1. Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs) [15 years post last treatment]

    AEs will be collected.

Secondary Outcome Measures

  1. Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples [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. [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 [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 [15 years]

    Number of deaths will be summarized.

  5. Time to death [15 years]

    Time to death will be summarized.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Duarte California United States 91010
2 GSK Investigational Site Denver Colorado United States 80218
3 GSK Investigational Site Jacksonville Florida United States 32224
4 GSK Investigational Site Miami Florida United States 33136
5 GSK Investigational Site Tampa Florida United States 33612
6 GSK Investigational Site Atlanta Georgia United States 30322
7 GSK Investigational Site Iowa City Iowa United States 52242-1009
8 GSK Investigational Site Lexington Kentucky United States 40536
9 GSK Investigational Site Baltimore Maryland United States 21201
10 GSK Investigational Site Bethesda Maryland United States 20892
11 GSK Investigational Site Boston Massachusetts United States 02215
12 GSK Investigational Site Ann Arbor Michigan United States 48109
13 GSK Investigational Site Rochester Minnesota United States 55905
14 GSK Investigational Site Saint Louis Missouri United States 63110
15 GSK Investigational Site New York New York United States 10065
16 GSK Investigational Site Durham North Carolina United States 27710
17 GSK Investigational Site Columbus Ohio United States 43210
18 GSK Investigational Site Portland Oregon United States 97239
19 GSK Investigational Site Philadelphia Pennsylvania United States 19104
20 GSK Investigational Site Philadelphia Pennsylvania United States 19111
21 GSK Investigational Site Pittsburgh Pennsylvania United States 15232
22 GSK Investigational Site Nashville Tennessee United States 37203
23 GSK Investigational Site Dallas Texas United States 75235
24 GSK Investigational Site Houston Texas United States 77030
25 GSK Investigational Site Salt Lake City Utah United States 84112
26 GSK Investigational Site Richmond Virginia United States 23298
27 GSK Investigational Site Milwaukee Wisconsin United States 53226
28 GSK Investigational Site Toronto Ontario Canada M5G 2M9
29 GSK Investigational Site Montreal Quebec Canada H1T 2M4
30 GSK Investigational Site Montréal Quebec Canada H2X 0A9
31 GSK Investigational Site Groningen Netherlands 9713 GZ
32 GSK Investigational Site Barcelona Spain 08035
33 GSK Investigational Site Madrid Spain 28040
34 GSK Investigational Site Madrid Spain 28050
35 GSK Investigational Site Sevilla Spain 41013
36 GSK Investigational Site London United Kingdom NW1 2PG
37 GSK Investigational Site Manchester United Kingdom M20 4BX
38 GSK Investigational Site Sutton United Kingdom SM2 5PT

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT03391778
Other Study ID Numbers:
  • 208750
  • ADP-0000-002
First Posted:
Jan 5, 2018
Last Update Posted:
Feb 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GlaxoSmithKline
Long Term Follow Up
Adoptive Cell Therapy
Replication Competent Lentivirus

Study Results

No Results Posted as of Feb 2, 2022