Fludarabine And Busulfan As Conditioning For Patients With Chronic Myeloid Leukemia Or Myelodysplastic Syndrome Transplanted With Hematopoietic Stem Cells From HLA-Compatible Related Or Unrelated Donors
OBJECTIVES: I. Determine the incidence of nonrelapse mortality at 100 days after allogeneic
peripheral blood stem cell transplantation in patients with chronic myelogenous leukemia
(CML) or myelodysplastic syndrome (MDS) treated with fludarabine and busulfan. II. Determine
the incidence of donor stem cell engraftment in patients treated with this regimen. III.
Determine the incidence and severity of acute graft-vs-host disease in patients treated with
this regimen. IV. Determine the incidence of persistent or recurrent CML or MDS in patients
treated with this regimen. V. Determine the safety of this regimen in these patients.
OUTLINE: Patients receive a conditioning regimen comprising fludarabine IV on days -9 to -6
and oral busulfan every 6 hours on days -5 to -2. Patients undergo allogeneic peripheral
blood stem cell transplantation on day 0. Patients receive graft-vs-host disease prophylaxis
comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine orally or IV twice daily
on days -1 to 100 followed by a taper until day 180. Patients are followed every 6 months
for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1.5 years.
Primary Purpose: Treatment
Claudio Anasetti, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|