Status:
TERMINATED
Rapamycin for Prevention of Chronic Graft-Versus-Host Disease
Lead Sponsor:
Yale University
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00623012
Start Date
February 1 2008
End Date
August 1 2013
Last Update
February 3 2017
Active Locations (1)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06520