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NCT05713214 · ClinicalTrials.gov registry record
Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products
A clinical trial of Relapsed Hematologic Malignancy and Refractory Hematologic Malignancy, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- 1,000
- Enrollment target
- 1
- Study location
NCT05713214: Recruiting study of Relapsed Hematologic Malignancy and Refractory Hematologic Malignancy, sponsored by St. Jude Children's Research Hospital.
NCT05713214 is a study of Relapsed Hematologic Malignancy and Refractory Hematologic Malignancy that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 1,000 participants, above the 101-participant average among 3 other Relapsed Hematologic Malignancy trials with a reported enrollment target (890% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05713214, a study of Relapsed Hematologic Malignancy and Refractory Hematologic Malignancy, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- 1,000 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Obtain histories for detection of significant delayed medical events after receipt of a gene therapy product on a St. Jude investigator-initiated clinical trial.
Conditions Studied
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2023-02-08 |
| Est. Completion | 2052-12-01 |
What NCT05713214 shows while recruiting
NCT05713214 is an observational study that tracks outcomes without assigning an intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 101-participant average among 3 other Relapsed Hematologic Malignancy trials with a reported enrollment target (890% higher).
The record links to 2 conditions, with Relapsed Hematologic Malignancy appearing as the primary indexed condition, and to 0 interventions.
NCT05713214 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT05713214 about?
NCT05713214 is a clinical study titled "Long-term Follow-up After Adoptive Transfer of Genetically Modified Cell Products". 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...
What is the current status of trial NCT05713214?
This trial is currently recruiting. The enrollment target is 1,000 participants. The study started on 2023-02-08. Estimated completion is 2052-12-01.
What conditions does trial NCT05713214 study?
This clinical trial studies the following conditions: Relapsed Hematologic Malignancy, Refractory Hematologic Malignancy.
Who is sponsoring clinical trial NCT05713214?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05713214 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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