Expired Study
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New Haven, Connecticut 06520


Purpose:

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.


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


NCT ID:

NCT00623012


Primary Contact:

Principal Investigator
Stuart Seropian, M.D.
Yale University


Backup Contact:

N/A


Location Contact:

New Haven, Connecticut 06520
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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