Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation for the Treatment of "Less Advanced" Myelodysplasi
- Determine the non-relapse toxicity and mortality on day 100 and at 1 year after
transplantation in patients with low or intermediate-risk myelodysplastic syndrome
treated with busulfan, cyclophosphamide, and allogeneic peripheral blood stem cell
- Determine the incidence of donor stem cell engraftment and relapse-free survival in
these patients treated with this regimen.
- Determine the incidence and severity of acute and chronic graft-versus-host disease and
invasive fungal infections in these patients treated with this regimen.
- Determine the incidence of relapse in these patients treated with this regimen.
OUTLINE: Peripheral blood stem cells (PBSC) or bone marrow are harvested from a related or
unrelated compatible donor. PBSC are selected for CD34+ cells.
Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on
days -3 and -2. Allogeneic PBSC or bone marrow is infused on day 0.
As graft-versus-host disease prophylaxis, patients receive cyclosporine IV beginning on day
-1 and continuing orally twice daily (if feasible) until day 51 followed by a taper.
Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Patients are followed through day 100, every 6 months for 2 years, and then annually
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.
Primary Purpose: Treatment
H. Joachim Deeg, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|