LTFU for All Cell and Gene Therapy Studies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AZD5851, AZD0754.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma, Prostate Cancer. Basic parameters: 18 years — 130 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Japan, South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A LOng-term Follow-up Master Protocol for Participants Who Received Cell or Gene Therapies in Other AstraZeneca StUdieS (LOCUS)
Overview
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.
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.
Interventions
- Biological AZD5851
Safety follow-up for up to 15 years of subjects who received AZD5851 in study NCT06084884. - Biological AZD0754
Safety follow-up for up to 15 years of subjects who received AZD0754 in study NCT06267729.
Primary outcome measures
- Incidence of specific AEs [Time frame: Maximum of 15 years post dosing]
Secondary outcome measures (2)
- Disease progression status and Overall survival [Time frame: Maximum of 15 years post dosing.]
- Kinetics parameters that indicate persistence (eg, Clast and Tlast) [Time frame: Maximum of 15 years post dosing]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
Not applicable
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 18 centers
- Research Site — Phoenix
- Research Site — Duarte
- Research Site — Orange
- Research Site — San Francisco
- Research Site — Washington D.C.
- Research Site — Jacksonville
- Research Site — Tampa
- Research Site — Atlanta
- … and 10 more centers
Japan · 3 centers
- Research Site — Kashiwa
- Research Site — Kyoto
- Research Site — Osakasayama-shi
South Korea · 3 centers
- Research Site — Seoul
- Research Site — Seoul
- Research Site — Seoul
Australia · 1 center
- Research Site — East Melbourne
Identifiers
NCT: NCT06194461 · D9341C00001