34
Participants
Start Date
November 30, 2005
Primary Completion Date
June 30, 2024
Study Completion Date
March 11, 2025
filgrastim
All patients will receive G-CSF 5 mcg/kg/day intravenous (IV) (dose rounded to vial size) based on the actual body weight IV beginning on day +1 after umbilical cord blood (UCB) infusion. G-CSF will be administered daily until the absolute neutrophil count (ANC) exceeds 2.5 x 10\^9/L for three consecutive days and then discontinued. If the ANC decreases to \<1.0 x 10\^9/L, G-CSF will be reinstituted.
busulfan
Administered 1.1 mg/kg if \<12 kg intravenous (IV) every 6 hours (0.8 mg/kg if \>12 kg IV every 6 hours on Days -8 through -5.
cyclosporine
Patients will receive cyclosporine (CSA) therapy beginning on day -3 maintaining a level of \>200 ng/mL. For children \< 40 kg the initial dose will be 2.5 mg/kg intravenous (IV) over 2 hours every 8 hours.
fludarabine phosphate
Administered 25 mg/m\^2 intravenous (IV) over 60 minutes on Days -4 through -2.
melphalan
Administered 60 mg/m\^2 intravenous (IV) over 30 minutes on Days -4 through -2.
mycophenolate mofetil
All patients will begin mycophenolate mofetil (MMF) on day -3. Patients \<45 kilograms will receive MMF at the dose of 15 mg/kg/dose every 8 hours (max dose 1gm/dose) orally or intravenously (PO or IV).
umbilical cord blood transplantation
The product is infused via IV drip directly into the central line without a needle, pump or filter on Day 0.
Masonic Cancer Center, University of Minnesota, Minneapolis
Masonic Cancer Center, University of Minnesota
OTHER