LTFU for All Cell and Gene Therapy Studies
LOCUS
A LOng-term Follow-up Master Protocol for Participants Who Received Cell or Gene Therapies in Other AstraZeneca StUdieS (LOCUS)
1 other identifier
observational
64
4 countries
25
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2025
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2023
CompletedFirst Posted
Study publicly available on registry
January 8, 2024
CompletedStudy Start
First participant enrolled
September 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2041
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 29, 2041
June 27, 2025
June 1, 2025
16.2 years
December 7, 2023
June 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Disease progression status and Overall survival
Maximum of 15 years post dosing.
Kinetics parameters that indicate persistence (eg, Clast and Tlast)
Maximum of 15 years post dosing
Study Arms (2)
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
Interventions
Eligibility Criteria
Participants who have been treated with Cell/Gene therapy products in AstraZeneca clinical trials.
You may qualify if:
- The participant has received a cell or gene therapy in another AstraZeneca protocol.
- Provision of signed and dated, written informed consent before any study-specific procedures.
You may not qualify if:
- Not applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (25)
Research Site
Phoenix, Arizona, 85054, United States
Research Site
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
Biospecimen
Whole blood, tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2023
First Posted
January 8, 2024
Study Start
September 17, 2025
Primary Completion (Estimated)
November 29, 2041
Study Completion (Estimated)
November 29, 2041
Last Updated
June 27, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 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.
- Access Criteria
- 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.
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.