For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Both Arms: 30 mg/m^2 IV over 1 hour Day -6 to Day -2
Other Name: Fludara
Arm 1: 50 mg/kg IV over 2 hours Day -6
Other Name: Cytoxan
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.
Other Name: Mycophenolate Mofetil
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.
Other Name: Rapamycin
Both Arms: 200 cGy on Day -1
Other Name: Total body irradiation
Biological: Umbilical cord blood cell infusion
Both Arms: Day 0
Other Name: UCB
Arm 2: 15 mg/kg IV every 12 hours Day -6 to Day -4
Other Name: Anti-thymocyte Globulin