Rapamycin for Prevention of Chronic Graft-Versus-Host Disease
Stopped early · Phase 1/Phase 2
Conditions studied: Graft Versus Host Disease
In brief
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.
Key facts
- Study ID
- NCT00623012
- Run by
- Yale University
- People needed
- 2
- Starts
- 2008-02-01
- Expected to finish
- 2013-08-01
- Last updated by the study team
- 2017-02-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years
- Received an allogeneic MSD or MUD PBSCT
- 24 weeks post SCT
- Currently on Tacrolimus for GVHD prophylaxis
- Deemed eligible for tapering off of Tacrolimus by primary BMT physician
You may not qualify if…
- Relapsed Disease
- Ongoing GVHD
- Patients whose immunosuppression is being stopped early to treat or prevent relapse
- Patients with pure red cell aplasia due to ABO mismatched donor
- Ongoing thrombotic microangiopathy
- Allergy to rapamycin
- Women of childbearing potential must have a negative serum pregnancy test performed prior to the start of treatment
Where it is running
- Yale University School of Medicine — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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