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.
- 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
- 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