LTFU for All Cell and Gene Therapy Studies (LOCUS)

March 22, 2024 updated by: AstraZeneca

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Research Site
    • California
      • Duarte, California, United States, 91010
        • Research Site
      • Orange, California, United States, 92868
        • Research Site
      • San Francisco, California, United States, 94143
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Research Site
      • Tampa, Florida, United States, 33612
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Research Site
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Research Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Research Site
    • New York
      • New York, New York, United States, 10065
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15237
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants who have been treated with Cell/Gene therapy products in AstraZeneca clinical trials.

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AZD5851
Follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884
Biological: AZD5851
Safety 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
Biological: AZD0754
Safety follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of specific AEs
Time Frame: Maximum of 15 years post dosing
To determine long-term safety of previous treatment with applicable cell and gene therapy products
Maximum of 15 years post dosing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease progression status and Overall survival
Time Frame: Maximum of 15 years post dosing.
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)
Time Frame: Maximum of 15 years post dosing
To characterise the long-term persistence of the cell or gene therapy product.
Maximum of 15 years post dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 12, 2024

Primary Completion (Estimated)

November 29, 2041

Study Completion (Estimated)

November 29, 2041

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

January 5, 2024

First Posted (Actual)

January 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9341C00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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