41
Participants
Start Date
July 23, 2007
Primary Completion Date
September 25, 2014
Study Completion Date
April 16, 2015
umbilical cord blood transplantation
Infusion of umbilical cord blood
Allopurinol
Administration begins Day -7 through Day 0, tablet or powder prescribed on an individual basis.
fludarabine phosphate
40 mg/m\^2 intravenously over 1 hour on Days -6, -5, -4, -3, -2
Cyclophosphamide
50 mg/kg intravenous over 2 hours on Day -6
Total body irradiation
200 cGy on Day -1
Treg infusion
Infusion of T regulatory cells on Day +1 (also Day +15 for Dose level 5 only). Dose escalation ranges include 1, 3, 10, 30, 100, 300 1000, and 300 x 10\^5 Treg/kg.
Sirolimus
Beginning on day -3 and continuing until day +100, patients receive sirolimus intravenously (IV) with 8-12 mg oral loading dose followed by a single dose of 4mg/day with a target serum concentration of 3-12 mg/mL with a taper until day +180.
Masonic Cancer Center at University of Minnesota, Minneapolis
Masonic Cancer Center, University of Minnesota
OTHER