Leukemia Clinical Trial
Official title:
Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation for the Treatment of "Less Advanced" Myelodysplasi
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Peripheral stem cell transplantation may be able to replace
immune cells that were destroyed by chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral
stem cell transplantation in treating patients who have myelodysplastic syndrome.
OBJECTIVES:
- 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
transplantation.
- 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
thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.
;
Primary Purpose: Treatment
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