A Phase I/II Study of Sirolimus in Addition to Tacrolimus and Methotrexate for the Prevention of Acute-Graft-Versus-Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplantation From Unrelated Donors
- Determine the safety and efficacy of sirolimus when administered with tacrolimus and
methotrexate for the prevention of acute graft-versus-host disease (GVHD) in patients
with hematological malignancies undergoing hematopoietic stem cell transplantation from
- Determine the absorption and pharmacokinetics of sirolimus in patients treated with
- Correlate sirolimus blood concentration with prevention of GVHD or toxicity in patients
treated with this regimen.
- Determine the severity of post-transplantation mucositis in patients treated with this
OUTLINE: This is a nonrandomized, open-label, pilot study.
Patients receive oral sirolimus once daily on days -3 to 175 and tacrolimus IV continuously
beginning on day -3 and continuing until the patient is able to tolerate food and then
orally twice daily until day 175. Patients also receive methotrexate IV on days 1, 3, 6, and
11. Treatment continues in the absence of acute graft-vs-host disease or unacceptable
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 3 years.
Masking: Open Label, Primary Purpose: Supportive Care
Hans-Peter Kiem, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|