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

Summary

Human gene therapy products are designed to achieve therapeutic effect through genetic modifications of human cells using retroviral or lentiviral vectors, resulting in permanent or long-acting changes in the human body. With this genetic modification comes risk of undesirable adverse events. Due to this risk, the Food and Drug Administration (FDA) and the Center for Biologics Evaluation and research (CBER) require long-term follow-up (15 years) of participants that receive investigational gene therapy products that meet defined criteria. This protocol will provide a mechanism by which to appropriately monitor participants that have received a genetically modified cellular product on a St. Jude initiated study.

Eligibility

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.

Conditions3

Locations1 site

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