30
Participants
Start Date
September 4, 2012
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2026
Alemtuzumab 0.3 mg
0.3 mg/kg intravenously (IV) on days -12 through -10
Cyclophosphamide
cyclophosphamide 50 mg/kg IV on days -9 through -6
Busulfan
busulfan 0.8 or 1.1 mg/kg IV on days -5 through -2
Stem Cell Transplantation
"Unrelated donor bone marrow will be collected in the usual manner using established parameters determined by the National Marrow Donor Program. A minimum of 3 x 10\^8 nucleated cells/kg recipient weight will be collected with a goal of ≥ 5 x 10\^8 nucleated cells/kg recipient weight.~Umbilical cord blood selection will be per the current University of Minnesota Cord Blood Unit Selection algorithm. One or two units may be used to obtain the minimum cell dose. One of the UCB units selected for transplantation must contain ≥ 3.5 x 10\^7 nucleated cells/kg recipient weight based on cell numbers at time of cryopreservation, and the total combined cell dose of both units must be \> 5.0 x 10\^7 nucleated cells/kg."
Fludarabine phosphate 40 mg
40 mg/m\^2 IV on days -5 through -2 (for children \< 6 months and/or \< 10 kg weight dose at 1.33 mg/kg)
Melphalan
140 mg/m\^2 IV on day -3
Alemtuzumab 0.2 mg
0.2 mg/kg intravenously (IV) on days -14 through -10
Busulfan
busulfan 0.8 or 1.1 mg/kg IV on days -9 through -6
Fludarabine phosphate 30 mg
fludarabine 30 mg/m\^2 IV on days -8 through -4
MESNA
administered as per the standard institutional protocol.
RECRUITING
Masonic Cancer Center, University of Minnesota, Minneapolis
Masonic Cancer Center, University of Minnesota
OTHER