Long-Term Follow-Up Study After Receiving Genetically Modified Cell Therapy for Blood Cancers at St. Jude

What this Trial Is About

This research focuses on long-term follow-up for people who have received gene therapy products that modify human cells genetically. These products are designed to create permanent or lasting changes in the body, but they carry risks of unwanted side effects. To ensure safety, the FDA and other regulatory bodies require monitoring for up to 15 years after treatment with such investigational gene therapies, especially those initiated by St. Jude Childrens Research Hospital. Participants in this prospective, non-therapeutic study will be monitored after completing their initial gene therapy trial. There are no treatment groups or placebo controls since this is an observational study. The follow-up includes routine health assessments and blood sample collection to check for long-term effects of the gene-modified cellular product. Some evaluations may be done locally alongside the St. Jude research team. Clinical data from the original gene therapy treatment and ongoing health status will also be reviewed. During the 15 years of follow-up, participants will undergo regular history taking, physical exams, and blood tests as guided by FDA recommendations. The study team will collect information on patient demographics, disease history, disease status, treatment details, and any additional therapies or events like relapse or death. The primary goal is to detect any delayed medical effects after receiving gene therapy. This long-term monitoring helps ensure ongoing safety and gathers important data over many years.

Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products