A Phase II Trial of Sirolimus as Treatment of Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host Disease
The purpose of this trial is to study the effectiveness of an immunosuppressive drug,
sirolimus, in the treatment of chronic graft versus host disease in combination with
prednisone. Graft versus host disease (GVHD) is a common complication in patients who have
received blood or marrow transplantation from a related or unrelated donor. Chronic GVHD
occurs approximately 100 days after transplantation and is the result of the donor immune
system recognizing the patient's tissues as foreign and creating harmful effects on the
patient';s organs. We hope the use of sirolimus will decrease the significant disabling
effects and deaths caused by chronic GVHD.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical activity will be monitored at 3 month intervals after the initiation of sirolimus until 2 years after the initiation of sirolimus
every 3 months until 2 years after enrollment
No
Laura Johnston
Principal Investigator
Stanford University
United States: Institutional Review Board
BMT175
NCT00388362
November 2005
October 2012
Name | Location |
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Stanford University School of Medicine | Stanford, California 94305-5317 |