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NCT00623012 · ClinicalTrials.gov registry record · Phase 1
Rapamycin for Prevention of Chronic Graft-Versus-Host Disease
A Phase 1 study, sponsored by Yale University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT00623012 is a Phase 1 study that was terminated before completion, run by Yale University. The registered enrollment target is 2 participants.
The verdict
NCT00623012, a Phase 1 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate feasibility, toxicity and efficacy of using Rapamycin to prevent chronic graft-versus-host-disease (GVHD) during and after the tacrolimus taper in recipients of allogeneic stem cell transplant. Our hypothesis is that the T cells that can cause chronic GVHD are suppressed but not eliminated by calcineurin inhibitors. Therefore, when the calcineurin inhibitors are discontinued, the T cells may get activated and result in GVHD. Rapamycin on the other hand will allow anergy formation and thus when discontinued, T cells should not get activated. The schedule is designed to have therapeutic rapamycin levels as the tacrolimus is discontinued. Rapamycin will be continued as a single agent for additional 4 weeks and be tapered off in two weeks.
Interventions
- DRUG Tacrolimus
- DRUG Rapamycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2008-02 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00623012
The ClinicalTrials.gov registry entry for NCT00623012 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tacrolimus is the first listed.
NCT00623012 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00623012 about?
NCT00623012 is a clinical study titled "Rapamycin for Prevention of Chronic Graft-Versus-Host Disease". The objective of this study is to evaluate feasibility, toxicity and efficacy of using Rapamycin to prevent chronic graft-versus-host-disease (GVHD) during and after the tacrolimus taper in recipients of allogeneic stem cell transplant. Our hypothesis is that the T cells that can cause chronic GVHD...
What is the current status of trial NCT00623012?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2008-02. Estimated completion is 2013-08.
What interventions are being tested in trial NCT00623012?
The interventions under investigation include: Tacrolimus (DRUG), Rapamycin (DRUG).
Who is sponsoring clinical trial NCT00623012?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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