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NCT05784415 · ClinicalTrials.gov registry record
Observational Study of People Living With HIV Treated With CD19-directed CAR T Cell
A clinical trial, sponsored by AIDS Malignancy Consortium.
- Completed
- Registry status
- 30
- Enrollment target
NCT05784415: Completed study, sponsored by AIDS Malignancy Consortium.
NCT05784415 is a clinical trial that has completed, run by AIDS Malignancy Consortium. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05784415 has completed, sponsored by AIDS Malignancy Consortium.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study Summary
This protocol will develop an observational cohort of PLWH who have been or are being treated with CAR19 therapy outside of an AMC clinical trial. Following regulatory approval of this protocol, sites will be asked to capture information of participants, who carry a diagnosis of HIV disease AND received CAR19 therapy outside of a clinical trial between August 30, 2017 and August 31, 2021. Data captured will include data points are available as part of standard of care for participants undergoing CAR19 therapy. AMC investigators, as well as non-AMC investigators will identify eligible participants to the CIBMTR, who in turn will provide the AMC statistical center with de-identified data
Primary Outcome
Toxicities related to CAR19 therapy will be reported by Common Terminology for Adverse Events (CTCAE) criteria, as well as American Society for Transplantation and Cellular Therapy (ASTCT) criteria (for cytokine release syndrome)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-05-22 |
| Est. Completion | 2024-11-14 |
What the finished NCT05784415 record still lists
NCT05784415 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT05784415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05784415 about?
NCT05784415 is a clinical study titled "Observational Study of People Living With HIV Treated With CD19-directed CAR T Cell". This protocol will develop an observational cohort of PLWH who have been or are being treated with CAR19 therapy outside of an AMC clinical trial. Following regulatory approval of this protocol, sites will be asked to capture information of participants, who carry a diagnosis of HIV disease AND rece...
What is the current status of trial NCT05784415?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2021-05-22. Estimated completion is 2024-11-14.
Who is sponsoring clinical trial NCT05784415?
This trial is sponsored by AIDS Malignancy Consortium, which has 45 total clinical trials registered on ClinicalTrials.gov.
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