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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
To determine the feasibility of using a combination of sirolimus and tacrolimus without methotrexate for GVHD prophylaxis after stem cell transplantation.
Corey Cutler, MD, MPH
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Center||Boston, Massachusetts 02115|