Long-term follow-up for patients who received genetically modified cell therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.