56
Participants
Start Date
May 1, 2023
Primary Completion Date
October 22, 2027
Study Completion Date
October 22, 2028
Peripheral Blood Stem Cell Transplant
On day 0, a target dose of 5 x 106 CD34 cells/kg will be infused.
Allopurinol 300 MG
300 mg/day from day -7 to day 0. Allopurinol 150mg/m2/day for pediatric participants.
Fludarabine
30 mg/m2 IV over 1 hour. Administered on day -6 to day -2.
Cyclophosphamide
Administered as a 2 hour IV infusion on day -6, +3, and +4.
Bone Marrow Cell Transplant
On day 0, a target dose of 3 x 108 nucleated cells/kg recipient weight will be infused.
Total Body Irradiation
The dose of TBI will be 200 cGy given in a single fraction on day -1.
Sirolimus Pill
"All participants begin +5 to day +60.~Loading dose on day +5 of 5 mg/m2/day orally once (max dose of 8 mg).~Maintenance dose 2.5 mg/m2 orally daily to maintain a level of 8-12 ng/ml (max dose of 4 mg)."
Mycophenolate Mofetil
"All patients begin day +5 through day +35.~3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 doses. In obese patients (\>125% IBW) 15 mg/kg every 12 hours may be considered. Pediatric patients will receive MMF at the dose of 15 mg/kg/dose (maximum of 1 gram per dose) every 8 hours."
RECRUITING
Masonic Cancer Center at University of Minnesota, Minneapolis
Masonic Cancer Center, University of Minnesota
OTHER