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A Phase II Trial of Sirolimus as Treatment of Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host Disease

To study the effectiveness of an immunosuppressive drug, sirolimus in the treatment of chronic graft versus host disease in combination with prednisone.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : Prednisone
  • drug : Sirolimus

Phase: Phase 2

Eligibility

Ages Eligible For Study:

13 Years - N/A

Inclusion Criteria

- Histologically-confirmed active chronic GVHD >100 days following allogeneic bone marrow/peripheral blood/umbilical cord blood transplantation that has failed prior therapy. In the event that histological confirmation poses undue risk, clinical evaluation is sufficient. - Women must have a negative pregnancy test before sirolimus administration and women of child-bearing potential agree to use a medically acceptable contraceptive throughout the treatment period and for 3 months after discontinuation of sirolimus. Any woman becoming pregnant during the treatment period must discontinue the use of sirolimus. - Absolute neutrophil count (ANC) >1000/mm^3, unless receiving G-CSF to maintain neutrophil count >500/mm^3 - Discontinuation of cyclosporine or FK506 at the time of initiating sirolimus with cyclosporine trough level <100 mg/dl and FK506 level < 5 mg/dl - Karnofsky performance score > or = 50 during pre-study screening - Written, signed, and dated informed consent

External Links

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Contact information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
6507230822
Not Recruiting

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