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

Phase 2
18 Years
Not Enrolling
Graft Versus Host Disease, GVHD

Thank you

Trial Information

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.

Inclusion Criteria:

- Patients with hematologic malignancies who are at a high risk of complications after
conventional transplantation

- Availability of a related donor who is identical at 6 HLA loci

- Greater than 18 years of age

- Performance status 0-2

- Life expectancy of > 100 days

Exclusion Criteria:

- Pregnancy

- Evidence of HIV infection

- Heart failure uncontrolled medication

- Total bilirubin > 2.0mg/dl that is due to hepatocellular dysfunction

- AST >90

- Serum Creatinine >2.0

- Cholesterol > 300mg/dl while adequately treated

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Vincent Ho, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

January 2006

Completion Date:

July 2009

Related Keywords:

  • Graft Versus Host Disease
  • GVHD
  • non-myeloablative peripheral blood stem cell
  • tacrolimus
  • sirolimus
  • Graft vs Host Disease



Dana-Farber Cancer InstituteBoston, Massachusetts  02115