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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: Clinical Trial Phase 1 study, sponsored by Yale University.
NCT00623012 is a Phase 1 study that was terminated before completion, run by Yale University. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of patients free from graft versus host disease
Interventions
- DRUG Tacrolimus
- DRUG Rapamycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2008-02 |
| Est. Completion | 2013-08 |
| Phase | Phase 1 |
Why NCT00623012 stopped before completion
NCT00623012 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Tacrolimus is the first listed.
NCT00623012 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00623012's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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