Trial Information

Tacrolimus, Sirolimus and Methotrexate as Graft Versus Host Disease Prophylaxis After Allogeneic Non-Myeloablative Peripheral Blood Stem Cell Transplantation

- Patients will be admitted to the hospital and receive chemotherapy and stem cell
transplant(SCT). The total duration of hospitalization for the procedure is
approximately 8 days. Once admitted the patient will receive fludarabine daily for 4
days, busulfex once daily for 4 days. Two days after chemotherapy has ended, the
patient will receive the infusion of donor cells.

- Just prior to the transplant and following the transplant, patients will receive
sirolimus (orally), tacrolimus (orally) and low doses of methotrexate (chemotherapy).
Methotrexate will be given on days 1,3 and 6 after transplant.

- Sirolimus will be tapered beginning week 9 after transplant if there is no evidence of
GVHD and will be eliminated on week 26 if clinically feasible.

- Tacrolimus will be tapered beginning week 9 after transplant if there is no evidence of
GVHD and will be eliminated on week 26 if clinically feasible.

- Patients will also receive medication to help prevent possible infection.

- After stem cell infusion, patients will be examined and have blood tests weekly for 1
month. At the 1 month visit, a bone marrow biopsy will performed looking for evidence
of donor cells in the bone marrow. After the one month evaluation the patient will be
examined every 2 weeks and a repeat bone marrow performed 3-4 months after transplant.