Prostate Cancer Clinical Trial
— LOCUSOfficial title:
A LOng-term Follow-up Master Protocol for Participants Who Received Cell or Gene Therapies in Other AstraZeneca StUdieS (LOCUS)
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.
Status | Not yet recruiting |
Enrollment | 64 |
Est. completion date | November 29, 2041 |
Est. primary completion date | November 29, 2041 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 130 Years |
Eligibility | Inclusion Criteria: 1. The participant has received a cell or gene therapy in another AstraZeneca protocol. 2. Provision of signed and dated, written informed consent before any study-specific procedures. Exclusion Criteria: Not applicable - |
Country | Name | City | State |
---|---|---|---|
United States | Research Site | Atlanta | Georgia |
United States | Research Site | Columbus | Ohio |
United States | Research Site | Duarte | California |
United States | Research Site | Hackensack | New Jersey |
United States | Research Site | Houston | Texas |
United States | Research Site | Jacksonville | Florida |
United States | Research Site | New York | New York |
United States | Research Site | Orange | California |
United States | Research Site | Philadelphia | Pennsylvania |
United States | Research Site | Phoenix | Arizona |
United States | Research Site | Pittsburgh | Pennsylvania |
United States | Research Site | Portland | Oregon |
United States | Research Site | Rochester | Minnesota |
United States | Research Site | San Francisco | California |
United States | Research Site | Tampa | Florida |
United States | Research Site | Westwood | Kansas |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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. | |
Secondary | Kinetics parameters that indicate persistence (eg, Clast and Tlast) | To characterise the long-term persistence of the cell or gene therapy product. | Maximum of 15 years post dosing |
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