Adoptive Cell Therapy Long-term Follow-up (LTFU) Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03391778 |
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Recruitment Status :
Recruiting
First Posted : January 5, 2018
Last Update Posted : March 30, 2023
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Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
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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 |
|---|---|---|
| Neoplasms | Biological: GSK adoptive cell therapy | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
| Estimated 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 : | April 9, 2018 |
| Estimated Primary Completion Date : | April 1, 2032 |
| Estimated Study Completion Date : | April 1, 2032 |
| 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. |
Primary Outcome Measures :
- 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 Measures :
- 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.
- 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.
- 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).
- Number of deaths [ Time Frame: 15 years ]Number of deaths will be summarized.
- Time to death [ Time Frame: 15 years ]Time to death will be summarized.
Information from the National Library of Medicine
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391778
Contacts
| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
Locations
| United States, California | |
| GSK Investigational Site | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Mark Agulnik | |
| United States, Colorado | |
| GSK Investigational Site | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Gerald Falchook | |
| United States, Connecticut | |
| GSK Investigational Site | Recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Michael E Hurwitz | |
| United States, Florida | |
| GSK Investigational Site | Recruiting |
| Jacksonville, Florida, United States, 32224 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Steven Attia | |
| GSK Investigational Site | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Mihaela Druta | |
| United States, Georgia | |
| GSK Investigational Site | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Melinda Yushak | |
| United States, Iowa | |
| GSK Investigational Site | Recruiting |
| Iowa City, Iowa, United States, 52242-1009 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Varun V Monga | |
| United States, Kentucky | |
| GSK Investigational Site | Recruiting |
| Lexington, Kentucky, United States, 40536 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: John Villano | |
| United States, Maryland | |
| GSK Investigational Site | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Aaron Rapoport | |
| GSK Investigational Site | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: John Glod | |
| United States, Massachusetts | |
| GSK Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: George D Demetri | |
| United States, Michigan | |
| GSK Investigational Site | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Rashmi Chugh | |
| United States, Minnesota | |
| GSK Investigational Site | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Steven I Robinson | |
| United States, Missouri | |
| GSK Investigational Site | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Brian Van Tine | |
| United States, New York | |
| GSK Investigational Site | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Sandra P D'Angelo | |
| United States, North Carolina | |
| GSK Investigational Site | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Richard Riedel | |
| United States, Ohio | |
| GSK Investigational Site | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: David Liebner | |
| United States, Oregon | |
| GSK Investigational Site | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Lara Davis | |
| United States, Pennsylvania | |
| GSK Investigational Site | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Edward A Stadtmauer | |
| GSK Investigational Site | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Martin J. Edelman | |
| GSK Investigational Site | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Liza Villaruz | |
| United States, Tennessee | |
| GSK Investigational Site | Recruiting |
| Nashville, Tennessee, United States, 37203 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Melissa L Johnson | |
| United States, Texas | |
| GSK Investigational Site | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Samuel John | |
| GSK Investigational Site | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Dejka Araujo | |
| United States, Utah | |
| GSK Investigational Site | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Anna Chalmers | |
| United States, Virginia | |
| GSK Investigational Site | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Andrew Poklepovic | |
| United States, Washington | |
| GSK Investigational Site | Recruiting |
| Seattle, Washington, United States, 98109-1024 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Michael Wagner | |
| United States, Wisconsin | |
| GSK Investigational Site | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: John A Charlson | |
| Canada, Ontario | |
| GSK Investigational Site | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Adrian Sacher | |
| Canada, Quebec | |
| GSK Investigational Site | Recruiting |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Jonathan Noujaim | |
| Spain | |
| GSK Investigational Site | Recruiting |
| Barcelona, Spain, 08035 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Enriqueta Felip | |
| GSK Investigational Site | Recruiting |
| Madrid, Spain, 28040 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Victor Moreno García | |
| GSK Investigational Site | Recruiting |
| Madrid, Spain, 28050 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Emiliano Calvo Aller | |
| GSK Investigational Site | Recruiting |
| Sevilla, Spain, 41013 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Pilar Sancho Márquez | |
| United Kingdom | |
| GSK Investigational Site | Recruiting |
| London, United Kingdom, NW1 2PG | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Sandra Strauss | |
| GSK Investigational Site | Recruiting |
| Manchester, United Kingdom, M20 4BX | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Fiona Thistlethwaite | |
| GSK Investigational Site | Recruiting |
| Sutton, United Kingdom, SM2 5PT | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Centre +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Principal Investigator: Andrew Furness | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT03391778 |
| Other Study ID Numbers: |
208750 ADP-0000-002 ( Other Identifier: Adaptimmune Therapeutics ) |
| First Posted: | January 5, 2018 Key Record Dates |
| Last Update Posted: | March 30, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | IPD for this study will be made available via the Clinical Study Data Request site. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
| Time Frame: | IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study. |
| Access Criteria: | Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months. |
| URL: | http://clinicalstudydatarequest.com |
| 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 |