Hepatocellular Carcinoma, Prostate Cancer
Conditions
Keywords
Cell Therapy, Gene Therapy, Long term follow up, LTFU, Hepatocellular carcinoma, Prostate cancer
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.
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
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of specific AEs | Maximum of 15 years post dosing | To determine long-term safety of previous treatment with applicable cell and gene therapy products |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease progression status and Overall survival | Maximum of 15 years post dosing. | To determine long-term efficacy follow-up after previous treatment with a cell or gene therapy product |
| Kinetics parameters that indicate persistence (eg, Clast and Tlast) | Maximum of 15 years post dosing | To characterise the long-term persistence of the cell or gene therapy product. |
Countries
Australia, Japan, South Korea, United States
Contacts
Primary ContactAstraZeneca Clinical Study Information Center
Outcome results
None listed