Clinical trial · Observational
Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | CURATED_BROADER | 0.78 |
| Relapsed Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Obtain histories for detection of significant delayed medical events after receipt of a gene therapy product on a St. Jude investigator-initiated clinical trial.
- timeFrame
- 30 years
- description
- Obtain histories for detection of significant delayed medical events after receipt of a gene therapy product on a St. Jude investigator-initiated clinical trial.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available