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
ID Number 12-0241Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to compare two treatments for chronic graft-versus-host disease (GVHD), and evaluate how well your chronic GVHD responds to treatment.
You may qualify to take part in this research study because you have chronic GVHD that needs treatment. The standard treatment for chronic GVHD is a corticosteroid (such as prednisone) and a calcineurin inhibitor (cyclosporine or tacrolimus). Patients who have chronic GVHD that is not controlled by the standard treatment usually have other drugs added to their treatment. Or less often, they may receive other drugs instead of standard treatment.
In this study chronic GVHD will be treated with another drug (sirolimus) in addition to either:
- A corticosteroid, or
- A corticosteroid and a calcineurin inhibitor, such as cyclosporine or tacrolimus
Sirolimus will be added to both treatments because research suggests that it may have positive effects on immune cells and improve GVHD treatment.
Recruiting Patients: Yes