295
Participants
Start Date
June 30, 2005
Primary Completion Date
December 12, 2019
Study Completion Date
December 12, 2019
anti-thymocyte globulin
Equine ATG dose is 15 mg/kg intravenously (IV) every 12 hours for 6 doses on days -6, - 5, and -4.
cyclophosphamide
Cyclophosphamide 50mg/kg x 1 to be administered IV over 2 hours with high volume fluid flush on day -6.
Fludarabine
Fludarabine 40 mg/m2/day or 30 mg/m2/day intravenously (IV) as one hour infusion x 5 days, on day -6 to -2.
mycophenolate mofetil
Mycophenolate mofetil (MMF) 3 gram/day for patients who are ≥ 40 kg divided in 2 or 3 doses. Pediatric patient (\<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours.
umbilical cord blood transplantation
One or 2 UCB units may be infused to achieve the required cell dose.
total body irradiation
Administered Day -1, 200 cGy
Sirolimus
Sirolimus will be administered starting at day -3 with 8mg-12mg mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL. Levels are to be monitored 3 times/week in the first 2 weeks, weekly until day +60, and as clinically indicated until day +100 post-transplantation. In the absence of acute GVHD sirolimus may be tapered starting at day +100 and eliminated by day +180 post-transplantation.
Masonic Cancer Center at University of Minnesota, Minneapolis
Masonic Cancer Center, University of Minnesota
OTHER