IV Busulfan With Allo-BMT: Study for Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome

PHASE3CompletedINTERVENTIONAL
Enrollment

233

Participants

Timeline

Start Date

June 30, 2005

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
Myelodysplastic SyndromeLeukemiaAcute Myeloid Leukemia
Interventions
DRUG

Busulfan

"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%."

DRUG

Fludarabine

40 mg/m\^2 IV Daily Over 1 Hour x 4 Days

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

M.D. Anderson Cancer Center

OTHER

NCT00469144 - IV Busulfan With Allo-BMT: Study for Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndrome | Biotech Hunter | Biotech Hunter