Acute Lymphoblastic Leukemia Clinical Trial
Official title:
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
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 a related donor.
- 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 transplant.
- 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
clinical condition.
- 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
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