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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05713214
The ClinicalTrials.gov registry entry for NCT05713214 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 101-participant average among 3 other Relapsed Hematologic Malignancy trials with a reported enrollment target (890% higher). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Relapsed Hematologic Malignancy appearing as the primary indexed condition, and to 0 interventions.
NCT05713214 reports 1 study location spanning 1 distinct geographic area - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.