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| ID | Type | Description | Link |
|---|---|---|---|
| ADP-0000-002 | Other Identifier | Adaptimmune Therapeutics |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving ADP adoptive cell therapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADP adoptive cell therapy | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with delayed adverse events (AEs) and serious adverse events (SAEs) | AEs will be collected. | 15 years post last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Vesicular Stomatitis Virus G protein (VSV-G) Deoxyribonucleic acid (DNA) copies in peripheral blood samples | Peripheral blood samples will be collected for the assessment of VSV-G DNA copies. | 15 years |
| Number of participants with Woodchuck hepatitis virus post-transcriptional regulatory element (WPRE) or Psi DNA copies in peripheral blood samples. |
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Inclusion Criteria:
Exclusion Criteria:
- None
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Investigator Study Inquiries LTFU | Contact | 866-750-8796 | Clinicaltrials2@usworldmeds.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael Nathenson, MD | USWM CT, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University School of Medicine | Recruiting | Atlanta | Georgia | 30322 | United States |
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Peripheral blood samples will be collected for the assessment of WPRE or Psi DNA. |
| 15 years |
| Number of participants with integrated vector sequences and vector integration patterns identified in peripheral blood samples | Peripheral blood samples will be collected for the assessment of Integrated vector sequences and vector integration patterns (e.g., polyclonal, oligoclonal, or monoclonal). | 15 years |
| Number of deaths | Number of deaths will be summarized. | 15 years |
| Time to death | Time to death will be summarized. | 15 years |
| ADP Investigational Site | Recruiting | Baltimore | Maryland | 21201 | United States |
|
| National Cancer Institute - Center for Cancer Research | Completed | Bethesda | Maryland | 20892 | United States |
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Washington University School of Medicine in St. Louis | Recruiting | St Louis | Missouri | 63110 | United States |
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| Memorial Sloan Kettering Cancer Center - New York | Recruiting | New York | New York | 10065 | United States |
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| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| Oregon Health and Science University | Recruiting | Portland | Oregon | 97239 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
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| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
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| University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Froedtert Hospital | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | 3000 | Australia |
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| Princess Margaret Cancer Centre | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| Hôpital Maisonneuve-Rosemont | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
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| Klinikum rechts der Isar der Technischen Universität München | Recruiting | Munich | Bavaria | 81377 | Germany |
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| Uniklinik Köln | Recruiting | Cologne | North Rhine-Westphalia | 50937 | Germany |
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| Fondazione IRCCS - Istituto Nazionale dei Tumori | Recruiting | Milan | Lombardy | 20133 | Italy |
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| Antoni Van Leeuwenhoek Ziekenhuis | Recruiting | Amsterdam | 1066 CX | Netherlands |
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| Hospital Universitario Virgen del Rocío | Recruiting | Seville | 41013 | Spain |
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| University College London Hospitals NHS Foundation Trust | Recruiting | London | NW1 2PG | United Kingdom |
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| USWM CT Investigational Site | Recruiting | Manchester | M20 4BX | United Kingdom |
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| The Royal Marsden NHS Foundation Trust | Recruiting | Sutton | SM2 5PT | United Kingdom |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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