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LTFU for All Cell and Gene Therapy Studies (LOCUS)

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ClinicalTrials.gov Identifier: NCT06194461
Recruitment Status : Not yet recruiting
First Posted : January 8, 2024
Last Update Posted : March 25, 2024
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Prostate Cancer Biological: AZD5851 Biological: AZD0754

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 Design
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Study Type : Observational
Estimated Enrollment : 64 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A LOng-term Follow-up Master Protocol for Participants Who Received Cell or Gene Therapies in Other AstraZeneca StUdieS (LOCUS)
Estimated Study Start Date : June 12, 2024
Estimated Primary Completion Date : November 29, 2041
Estimated Study Completion Date : November 29, 2041

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.


Biospecimen Retention:   Samples With DNA
Whole blood, tissue

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06194461


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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United States, Arizona
Research Site
Phoenix, Arizona, United States, 85054
United States, California
Research Site
Duarte, California, United States, 91010
Research Site
Orange, California, United States, 92868
Research Site
San Francisco, California, United States, 94143
United States, Florida
Research Site
Jacksonville, Florida, United States, 32224
Research Site
Tampa, Florida, United States, 33612
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30322
United States, Kansas
Research Site
Westwood, Kansas, United States, 66205
United States, Minnesota
Research Site
Rochester, Minnesota, United States, 55905
United States, New Jersey
Research Site
Hackensack, New Jersey, United States, 07601
United States, New York
Research Site
New York, New York, United States, 10065
United States, Ohio
Research Site
Columbus, Ohio, United States, 43210
United States, Oregon
Research Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19104
Research Site
Pittsburgh, Pennsylvania, United States, 15237
United States, Texas
Research Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT06194461    
Other Study ID Numbers: D9341C00001
First Posted: January 8, 2024    Key Record Dates
Last Update Posted: March 25, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Cell Therapy
Gene Therapy
Long term follow up
 LTFU
Hepatocellular carcinoma
Prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
 Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases