Open Label Phase II Trial of Sirolimus in Combination With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Matched, Related Allogeneic Hematopoietic Stem Cell Transplantation
- Therapy to prevent GVHD will consist of an infusion of tacrolimus intravenously and
sirolimus orally once per day starting 3 days before stem cell infusion. This will
take place in the hospital where the patient will remain for the duration of the
- Sirolimus will continue for 9 weeks at at stable dose, then will be tapered by 1/3 on
week 9 and 1/3 on week 17. It will be stopped on week 26 if there is no significant
evidence of GVHD. These dose modifications will occur at home and patients will be
seen weekly for the first 2 months after discharge.
- If GVHD is present, the tapering schedule wil be slower and based upon the patient's
- Tacrolimus will be given orally once the patient is discharged from the hospital and
will be tapered at the same schedule as sirolimus. Blood levels of both tacrolimus and
sirolimus will be monitored and the dose adjusted accordingly.
- During the year following stem cell transplant, blood work will be performed to
evaluate the immune system and GVHD.
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 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 Institute||Boston, Massachusetts 02115|