The purpose of this study is: 1. To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. 2. To evaluate disease free and overall survival after this conditioning regimen in patients with advanced acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). 3. To evaluate potential pharmacogenomic determinants of toxicity of this regimen. 4. To evaluate potential pharmacogenomic determinants of efficacy of this regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Daily intravenous dosing to target AVC
Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose.
All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times).
Infusion of bone marrow and donors(related/ unrelated).
The University of Chicago
Chicago, Illinois, United States
Maximum Tolerated Dose
Maximally tolerated area under the curve of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. The number reported will be an Area Under the Curve (AUC) measure reported in µmol-min/L.
Time frame: 5 years
Overall Survival
Overall Survival measured as median survival in days
Time frame: 5 years
Disease Free Survival
Disease Free Survival measured by median survival time in days
Time frame: 5 years
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