Rapamycin for Prevention of Chronic Graft-Versus-Host Disease
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic, Hematology |
| Therapuetic Areas: | Hematology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/16/2013 |
| Start Date: | February 2008 |
| End Date: | August 2013 |
| Contact: | Noelle Sowers, RN |
| Email: | noelle.sowers@yale.edu |
| Phone: | 203-785-2442 |
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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