Tacrolimus and Sirolimus as Graft Versus Host Disease Prophylaxis After Allogeneic Non-myeloablative Peripheral Blood Stem Cell Transplantation
- After the screening procedures confirm that the patient is eligible to participate in
the research study, they will be admitted to the hospital to receive chemotherapy and
stem cell transplantation (SCT). The duration of the hospitalization for the procedure
is approximately 8 days.
- Patients will receive fludarabine once daily over 30 minutes intravenously for 4 days
and busulfex once daily over 3 hours intravenously each day for the same 4 days.
- Just prior to the transplant and following the transplant the patient will receive
sirolimus and tacrolimus to help prevent Graft versus Host Disease (GvHD). Both
medications are taken orally.
- Patients will also take medications to help prevent possible infections (e.g.
acyclovir). Filgrastim, a white blood cell growth factor, will be given daily in an
injection under the skin, starting the day after the stem cell transplant and until the
patients blood counts have recovered.
- After the stem cell infusion, the patient will be examined and have blood tests weekly
for 1 month. At about the 1-month visit, a bone marrow biopsy and/or blood tests will
be performed to determine the percentage of donor's cells in the blood or bone marrow.
These tests will be repeated at 3-4 months after transplant.
- At 3-4 months after the transplant, patients will also have tests to reassess the
response of your disease to transplant. This may involve a bone marrow biopsy, blood
tests, and/or radiology studies depending upon the type of cancer.
- Follow-up will continue for the remainder of the patients life.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the incidence and severity of grade II-IV acute GvHD developing by day 100 following non-myeloablative PBSC transplantation using tacrolimus and sirolimus.
Vincent Ho, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|