Actively Recruiting
Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products
Led by St. Jude Children's Research Hospital · Updated on 2026-05-26
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a long-term follow-up study to monitor people who have received gene therapy products that modify human cells genetically. This study focuses on participants treated in St. Jude investigator-initiated clinical trials for relapsed or refractory blood cancers. The goal is to detect any significant delayed medical effects after receiving these gene therapies, following FDA guidelines for safety monitoring. Participants join this observational study after completing the initial clinical trial where they received a genetically modified cell product. There are no treatment groups, placebos, or control subjects in this study. The follow-up lasts up to 15 years post-infusion of the gene therapy product, with assessments conducted routinely over this time. During the study, participants will undergo regular evaluations including medical history reviews, physical exams, and blood sample collections. These assessments may be done locally in coordination with the St. Jude research team. Researchers will also review existing clinical data related to the participant's prior gene therapy treatment, including disease history, current status, treatments after gene therapy, relapse, and survival. The primary outcome is gathering detailed histories to identify any delayed medical issues over 30 years.
CONDITIONS
Brief Title
Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Receipt of a genetically modified cell product on a St. Jude investigator-initiated study within the prior 15 years.
You will not qualify if you...
- Inability or unwillingness of research participant and/or legal guardian/ representative to give written informed consent.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or local provider)
Duration - Up to 15 years post infusion
Participants undergo routine history, physical exams, and blood sample collections to monitor long-term effects after gene therapy treatment. Assessments may be done by a local provider in conjunction with the research team.
Periodic visits as coordinated with the research team and local providers
Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
A
Aimee Talleur, MD
S
Swati Naik, MBBS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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