Myelodysplastic Syndromes Clinical Trial
Official title:
Open Label Phase II Trial of Sirolimus in Combination With Tacrolimus for Graft-vs-Host Disease Prophylaxis After HLA-Matched, Unrelated, Allogeneic Hematopoietic Stem Cell Transplantation
The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus host disease (GVHD) in patients following stem cell transplant from an unrelated donor. This trial is designed to test the hypothesis that elimination of methotrexate in the unrelated donor group would lead to less transplant-related toxicity while still preserving the effective control of GVHD.
- Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and
sirolimus orally once daily starting 3 days before stem cell infusion. This will take
place in the hospital where the patient will remain for the duration of the transplant.
- Sirolimus will continue for approximately 100 days at a stable dose, then it will be
tapered slowly over the course of weeks to months to prevent a flare in GVHD.
- Patients will be seen in the clinic weekly for the first 2 months after discharge from
the hospital. If GVHD is present, tapering schedule will be slower and based on the
patient's clinical condition.
- Tacrolimus will also be given orally after the patient is discharged and will be
tapered on the same schedule as sirolimus.
- During the year following stem cell transplant, blood tests will be performed to
evaluate the immune system and graft versus host disease.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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