Busulfan and Fludarabine in Patients With AML and MDS

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.

Timeline

Start

2003-10

Primary completion

2008-11

Completion

2008-11

Drugs

Indications