Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSt. Jude Children's Research Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Receipt of a genetically modified cell product on a St. Jude investigator-initiated study within the prior 15 years.
Disqualifiers
Inability or unwillingness of research participant and/or legal guardian/ representative to give written informed consent.
Trial population
All participants who have received genetically modified cell therapy products on St. Jude investigator-initiated clinical studies.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Obtain histories for detection of significant delayed medical events after receipt of a gene therapy product on a St. Jude investigator-initiated clinical trial.
Obtain histories for detection of significant delayed medical events after receipt of a gene therapy product on a St. Jude investigator-initiated clinical trial.
Time frame
30 yearsSponsors and contacts
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Source ClinicalTrials.gov