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NCT01795573 · ClinicalTrials.gov registry record · Phase 1
Ex-vivo Expanded Donor Regulatory T Cells for Prevention of Acute Graft-Versus-Host Disease
A Phase 1 study of Graft-Versus-Host Disease, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT01795573: Completed Phase 1 study of Graft-Versus-Host Disease, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01795573 is a Phase 1 study of Graft-Versus-Host Disease that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 38 participants, below the 82-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01795573, a Phase 1 study of Graft-Versus-Host Disease, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
Clinical trial of allospecific regulatory t cells (Tregs) for prevention of acute graft-versus-host disease (GVHD) in human leukocyte antigen (HLA) identical sibling transplants.
Primary Outcome
MTD of donor Treg in combination with standard dose SIR/TAC immune suppression. The occurrence of dose-limiting toxicity in \>= 33% serves as the boundary for the MTD of donor Treg.
Conditions Studied
Interventions
- BIOLOGICAL Cultured Treg cells
Study Locations (1)
Florida
- H Lee Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2014-10-29 |
| Est. Completion | 2020-08-14 |
| Phase | Phase 1 |
What the finished NCT01795573 record still lists
NCT01795573 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 82-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Graft-Versus-Host Disease appearing as the primary indexed condition, and to 1 intervention - of which Cultured Treg cells is the first listed.
NCT01795573 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01795573 about?
NCT01795573 is a clinical study titled "Ex-vivo Expanded Donor Regulatory T Cells for Prevention of Acute Graft-Versus-Host Disease". Clinical trial of allospecific regulatory t cells (Tregs) for prevention of acute graft-versus-host disease (GVHD) in human leukocyte antigen (HLA) identical sibling transplants.
What is the current status of trial NCT01795573?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2014-10-29. Estimated completion is 2020-08-14.
What conditions does trial NCT01795573 study?
This clinical trial studies the following conditions: Graft-Versus-Host Disease.
What interventions are being tested in trial NCT01795573?
The interventions under investigation include: Cultured Treg cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01795573?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01795573 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01795573's enrollment target sits among peer trials
38 20th of 38 higher than 17 of 38 other Graft-Versus-Host Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Graft-Versus-Host Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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