Leukemia Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor 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 used to kill tumor cells. Sometimes the
transplanted cells are rejected by the body's normal tissues. Drugs such as cyclosporine may
prevent this from happening.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by
peripheral stem cell transplantation in treating patients who have chronic myelogenous
leukemia or myelodysplastic syndrome.
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
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