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Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)

Complete title: A Phase II/III Randomized, Multicenter Trial Comparing Sirolimus plus Prednisone and Sirolimus/Calcineurin Inhibitor plus Prednisone for the Treatment of Chronic Graft-versus-Host Disease

Research Study Number       2375.00
    
Principal Investigator       Paul Carpenter, MD
    
Phase       II/III

Look up trial at NIH

Research Study 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.

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "Look up trial at NIH" link above. **

Other eligibility criteria may apply.



Research Study Number       2375.00
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Bone Marrow and Hematopoietic Stem Cell Transplant (BMT and HSCT)

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