Busulfan and Fludarabine in Patients With AML and MDS
Status:
Completed
Trial end date:
2008-11-01
Target enrollment:
Participant gender:
Summary
Primary Objectives:
1. To administer multiple doses of an intravenous formulation of busulfan (Bu) at a dose
adjusted to yield a blood drug level with a median daily area under the plasma
concentration curve (AUC) of approximately 6,500 µMol-min. This dose will be given
intravenously over three hours once daily for four (4) days, in combination with
Fludarabine at a dose of 40 mg/m2 as preparation for bone marrow or peripheral stern
cell transplantation in patients with acute myeloid leukemia or myelodysplastic
syndromes.
2. To determine the outcome of Acute Myeloid Leukemia (AML)/myelodysplastic syndromes (MDS)
patients undergoing treatment with this regimen. Data regarding engraftment, toxicity,
relapse rate, long-term (disease-free) outcome, and overall survival will be collected.
3. To determine the safety profile of this regimen when utilized as preparation for
allogeneic transplantation.
4. To describe the plasma pharmacokinetics of busulfan when administered intravenously in
this regimen.