70
Participants
Start Date
September 4, 2018
Primary Completion Date
April 3, 2025
Study Completion Date
April 3, 2030
Immunosuppression Only Conditioning
E-ATG 40 mg/kg IV once daily for days -14 and -13. Prednisone: Tapering doses, given orally daily, and given prior to each daily dose of e-ATG on days -14 and -13 Pentostatin:4 mg/m2/day IV on days -9 and -5, cyclophosphamide:5 mg/kg orally daily on days -9 through -2
Reduced Intensity Conditioning
E-ATG 40 mg/kg IV once daily for days -14 and -13. Prednisone: Tapering doses, given orally daily, and given prior to each daily dose of e-ATG on days -14 and -13 Pentostatin:4 mg/m2/day IV on days -11 and -7, cyclophosphamide:3 mg/kg orally daily on days -11 through -4 Busulfan IV, pharmokinetically dosed, on days -3 and -2.
GVHD Prophylaxis
High-dose, post-transplantation cyclophosphamide (PTCy) 25-50 mg/kg on days +3 and +4, Mesna: 25-50 mg/kg weight based dosing, Tacrolimus 0.02 mg/kg on days +5 through +90, and mycophenolate mofetil (MMF) 15 mg/kg on days +5 through +25
Allogeneic HSC
Stem cell transplant
National Institutes of Health Clinical Center, Bethesda
National Marrow Donor Program, Minneapolis
National Cancer Institute (NCI)
NIH