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Sirolimus and prednisone for chronic GVHD
NCT01106833Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2010
- Primary completion
- Feb 2017
- Countries
- 1
- Sponsor
- Medical College of Wisconsin
- Modality
- Small Molecules
- Drugs
- sirolimus
- Conditions
- chronic graft-versus-host disease (cGVHD)
01
Overview
Phase 3, randomised, open-label trial of sirolimus in chronic graft-versus-host disease (cGVHD), sponsored by Medical College of Wisconsin. Started Apr 2010; status: completed.
02
Design
- Study design
- RandomizedOpen-label
03
Who it enrols
Patients with classic chronic GVHD or overlap syndrome, either newly diagnosed or inadequately responding to initial therapy, with adequate renal and hematologic function.
04
Registry description
This study is designed as a combined Phase II/III, randomized, open label, multicenter, prospective comparative study of sirolimus plus prednisone versus sirolimus/calcineurin-inhibitor plus prednisone for the treatment of chronic GVHD. Patients will be stratified by transplant center and will be randomized to an experimental arm of one of the two pre-specified experimental arms (sirolimus + prednisone or the comparator arm of sirolimus + calcineurin inhibitor + prednisone) in a 1:1 ratio.
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