Rapamycin for Prevention of Chronic Graft-Versus-Host Disease

• Status: Terminated
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: Everolimus; Sirolimus; Tacrolimus

Criteria

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