A Phase I/II Study of Immunologically Engineered rhG-CSF Mobilized Peripheral Blood Stem Cells (PBSC) for Allogeneic Transplant From HLA Identical, Related Donors for Treatment of Myeloid Malignancies
- Determine the incidence of grades II, III, and IV graft-vs-host disease (GVHD) in
patients with myelodysplastic syndromes (MDS), acute myeloid leukemia transformed from
MDS, or myeloproliferative disorders treated with immunologically engineered,
filgrastim (G-CSF)-mobilized, allogeneic peripheral blood stem cell transplantation.
- Determine the incidence of graft failure, relapse, and transplant-related mortality by
day 100 in patients treated with this regimen.
- Determine the incidence of chronic GVHD, in terms of number and duration of
immunosuppressant therapies, in patients treated with this regimen.
- Determine the feasibility of partial T-cell depletion in G-CSF-mobilized peripheral
blood stem cells.
OUTLINE: Patients receive conditioning with oral busulfan every 6 hours on days -7 to -4 and
cyclophosphamide IV on days -3 and -2. Immunologically engineered, filgrastim
(G-CSF)-mobilized, allogeneic peripheral blood stem cells are infused on day 0.
Patients receive graft-vs-host disease prophylaxis comprising methotrexate IV on days 1, 3,
6, and 11 and cyclosporine IV over 1-4 hours (orally twice daily when tolerated) on days -1
to 80 and then gradually tapered over 5 months beginning on day 81.
Patients are followed regularly through day 100 and then at 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
Masking: Open Label, Primary Purpose: Treatment
Incidence of grade II, III, and IV graft-versus-host disease
Ann E. Woolfrey, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Seattle Cancer Care Alliance||Seattle, Washington 98109|