At a glance
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A Phase II Study of High-Dose Intravenous Busulfan and Fludarabine With Allogeneic Marrow and Peripheral Blood Progenitor Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndromes
In Brief
A Phase 2 clinical trial evaluating Busulfan and Fludarabine for Leukemia. Completed, enrolled 200 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
130 mg/m\^2 injected through the intravenous catheter over three hours, once a day, for four days, starting immediately after Fludarabine.
40 mg/m\^2 through a central venous catheter over one hour, once a day, for four days.