Long-term follow-up for patients who received genetically modified cell therapy
Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products
This study is tracking the long-term health effects of gene therapy in patients with blood cancers to see how they are doing 15 years after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT05713214 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor the long-term effects of genetically modified cell products in patients who have undergone gene therapy for relapsed or refractory hematologic malignancies. Participants will be followed for 15 years post-infusion, with routine assessments including medical history, physical exams, and blood samples to evaluate any adverse effects or changes in health status. The study is designed to comply with FDA guidelines for long-term follow-up of gene therapy recipients, ensuring comprehensive data collection on patient outcomes and safety.
Who should consider this trial
Good fit: Ideal candidates are individuals who have received a genetically modified cell product as part of a St. Jude investigator-initiated study within the last 15 years.
Not a fit: Patients who have not received a genetically modified cell product or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the long-term safety and efficacy of gene therapy for hematologic malignancies.
How similar studies have performed: While long-term follow-up studies for gene therapy are becoming more common, this specific approach is aligned with FDA requirements and may provide novel insights into patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Receipt of a genetically modified cell product on a St. Jude investigator-initiated study within the prior 15 years. Exclusion Criteria: * Inability or unwillingness of research participant and/or legal guardian/ representative to give written informed consent.
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Aimee Talleur, MD — St. Jude Children's Research Hospital
- Study coordinator: Aimee Talleur, MD
- Email: referralinfo@stjude.org
- Phone: 866-278-5833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.