At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Study of Once Daily IV Busulfan With Fludarabine With Hemopoietic Stem Cell Transplantation for Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)
In Brief
A Phase 3 clinical trial evaluating Busulfan and Fludarabine for Myelodysplastic Syndrome and 2 related conditions. Completed, enrolled 233 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if giving busulfan in a dose based on blood levels, along with a fixed (unchanging) dose of fludarabine, is more effective and causes fewer side effects for AML or myelodysplastic syndrome patients than the standard method of giving a fixed busulfan dose based on body size, along with a fixed dose of fludarabine. The safety of dosing based on blood levels will also be studied.
Study Details
Timeline
Interventions
Fixed Dose = 130 mg/m\^2 IV Daily Over Three Hours x 4 Days. Adjusted Dose = 32 mg/m\^2 IV Over 2 Hours Test Dose x 1 Day. Proceeding dosage level determined by pharmacokinetic studies to achieve a daily area under curve (AUC) of 6,000 microMol-min ± 10%.
40 mg/m\^2 IV Daily Over 1 Hour x 4 Days