12
Participants
Start Date
August 31, 2012
Primary Completion Date
November 30, 2016
Study Completion Date
December 31, 2016
cyclophosphamide
60 mg/kg/day intravenous x 2 days pre-transplant, total dose 120 mg/kg
cyclosporine
Beginning on Day -3 pre-transplant maintaining a level of \>200 ng/mL. CSA dosing will be monitored and altered as clinically appropriate by Pharm D or physician, and discontinue at approximately day + 180 post-transplant.
Fludarabine
25 mg/m2/day intravenous as a 1 hour infusion for consecutive 3 days pre-transplant, total dose 75 mg/m2
mycophenolate mofetil
Beginning on day -3, use intravenous route between days -3 and +5, followed by oral administration on Day +6 through +30, if tolerated. 15mg/kg/dose for patients \<40 kg, 3 gm/day for patients \>40 kg.
total marrow irradiation
Dose escalating schedule per Cohort (TMI: 300 cGy) once daily.
umbilical cord blood transplantation
product will be infused via intravenous drip on Day 0 according to current University of Minnesota guidelines for Umbilical Cord Blood Grafts
Granulocyte colony-stimulating factor
5 mcg/kg/day intravenous or subcutaneous based on body weight beginning on Day +1 after umbilical cord blood infusion until absolute neutrophil count exceeds 2.5 x 10\^9/L for 3 consecutive days.
HLA-matched related donor bone marrow
Related donor bone marrow or mobilized stem cells will be collected (target cell dose 5x10\^8 nucleated cells/kg recipient weight, minimum 3x10\^8 nucleated cells/kg recipient weight) and infused without processing on day 0 according to University of Minnesota Blood and Marrow Transplant Program guidelines.
Masonic Cancer Center at University of Minnesota, Minneapolis
Masonic Cancer Center, University of Minnesota
OTHER