15
Participants
Start Date
May 15, 2017
Primary Completion Date
February 22, 2023
Study Completion Date
February 22, 2024
Fludarabine
Both Arms: 30 mg/m\^2 IV over 1 hour Day -6 to Day -2
Cyclophosphamide
Arm 1: 50 mg/kg IV over 2 hours Day -6
MMF
"Both Arms:~Mycophenolate mofetil (MMF) 3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 or 3 doses. In obese patients (\>125% IBW) 15 mg/kg every 12 hours may be considered. Pediatric patient (\<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours beginning Day -3. MMF dosing will be monitored and altered as clinically appropriate based on institutional guidelines. Patients will be eligible for MMF dosing and pharmacokinetics studies.~Stop MMF at Day +30 or 7 days after engraftment, whichever day is later, if no acute graft versus host disease (GVHD). (Definition of engraftment is 1st day of 3 consecutive days of absolute neutrophil count \[ANC) ≥ 0.5 x 109 /L\]). If no donor engraftment, do not stop MMF."
Sirolimus
"Both Arms:~Adult Dosing: Sirolimus will be administered starting at Day -3 with 8-12 mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL by high-performance liquid chromatography (HPLC) and will be monitored per institutional guidelines. In the absence of acute GVHD sirolimus may be tapered starting at Day +100 and eliminated by Day +180 post-transplantation.~Pediatric Dosing: Sirolimus will be administered starting on Day -3 with an oral loading dose of 10 mg followed by maintenance dosing of 2.5 mg/m\^2/day (Maximum total daily dose of 4mg) as per institutional guidelines. Target serum concentration goals are 3 to 12 mg/mL by high-performance liquid chromatography (HPLC) and will be monitored per institutional guidelines."
TBI
Both Arms: 200 cGy on Day -1
Umbilical cord blood cell infusion
Both Arms: Day 0
ATG
Arm 2: 15 mg/kg IV every 12 hours Day -6 to Day -4
Masonic Cancer Center at University of Minnesota, Minneapolis
Masonic Cancer Center, University of Minnesota
OTHER