NCT05713214 Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products
| NCT ID | NCT05713214 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Relapsed Hematologic Malignancy |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2023-02-08 |
| Primary Completion | 2052-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2023-02-08 with a primary completion date of 2052-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Aimee Talleur, MD
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT05713214 clinical trial?
This trial is open to participants of all sexes, studying Relapsed Hematologic Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05713214 currently recruiting?
Yes, NCT05713214 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT05713214 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT05713214 clinical trial?
NCT05713214 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Aimee Talleur, MD at St. Jude Children's Research Hospital. The trial plans to enroll 500 participants.