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Master LTFU study will monitor the long-term safety and tolerability of cell or gene therapy study participants from AstraZeneca for up to 15 years post last cell or gene therapy treatment.
This is a multi-centre and multinational basket study that will monitor the long-term safety and tolerability of cell or gene therapies in participants that have taken part in other AstraZeneca cell or gene therapy studies for up to 15 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD5851 | Follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884 |
| |
| AZD0754 | Follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5851 | Biological | Safety follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of specific AEs | To determine long-term safety of previous treatment with applicable cell and gene therapy products | Maximum of 15 years post dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Disease progression status and Overall survival | To determine long-term efficacy follow-up after previous treatment with a cell or gene therapy product | Maximum of 15 years post dosing. |
| Kinetics parameters that indicate persistence (eg, Clast and Tlast) |
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Inclusion Criteria:
Exclusion Criteria:
Not applicable
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Participants who have been treated with Cell/Gene therapy products in AstraZeneca clinical trials.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85054 | United States | ||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal
Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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Whole blood, tissue
| AZD0754 | Biological | Safety follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729. |
|
To characterise the long-term persistence of the cell or gene therapy product. |
| Maximum of 15 years post dosing |
| Duarte |
| California |
| 91010 |
| United States |
| Research Site | Orange | California | 92868 | United States |
| Research Site | San Francisco | California | 94143 | United States |
| Research Site | Washington D.C. | District of Columbia | 20007 | United States |
| Research Site | Jacksonville | Florida | 32224 | United States |
| Research Site | Tampa | Florida | 33612 | United States |
| Research Site | Atlanta | Georgia | 30322 | United States |
| Research Site | Westwood | Kansas | 66205 | United States |
| Research Site | Rochester | Minnesota | 55905 | United States |
| Research Site | St Louis | Missouri | 63110 | United States |
| Research Site | Hackensack | New Jersey | 07601 | United States |
| Research Site | New York | New York | 10065 | United States |
| Research Site | Columbus | Ohio | 43210 | United States |
| Research Site | Portland | Oregon | 97239 | United States |
| Research Site | Philadelphia | Pennsylvania | 19104 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15237 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | East Melbourne | 3002 | Australia |
| Research Site | Kashiwa | 227-8577 | Japan |
| Research Site | Kyoto | 606-8507 | Japan |
| Research Site | Osakasayama-shi | 589-8511 | Japan |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 06351 | South Korea |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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