33
Participants
Start Date
July 13, 2012
Primary Completion Date
April 25, 2017
Study Completion Date
April 25, 2017
Melphalan
140 mg/m2 by vein on Day -2 only for Fludarabine + Melphalan group.
Fludarabine
10 mg/m2 by vein on Days -7 to -4 for Melphalan + Thiotepa + Fludarabine group, or 40 mg on Days -5 to -2 for Fludarabine + Melphalan group.
Mycophenolate mofetil
15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or by mouth twice a day from Days -3 to +100 in the absence of Graft vs Host Disease (GvHD).
Tacrolimus
Starting dose 0.03 mg/kg or 0.015 mg/kg (ideal body weight) by vein starting on Day -2 and tapered around Day +180 if no Graft vs Host Disease (GvHD) is present.
Cord Blood Infusion
Cord blood infusion on Day 0. Each participant will receive cells from one unexpanded cord blood sample plus cells from a second cord blood sample that has undergone fucosylation.
Rituximab
375 mg/m\^2 by vein on Day -10 for B cell malignancy.
ATG
"1.25 mg/Kg by vein on Day -4.~1.75 mg/Kg by vein on Day -3."
Busulfan
Busulfan per standard of care, test dose either as an outpatient prior to admission or as an inpatient on Day -9. Busulfan pharmacokinetics performed with test dose and the first dose on Day -7 per standard of care. Doses of Days -5 and -4 subsequently adjusted to target an AUC of 4,000 microMol.min-1.
Clofarabine
30 mg/m\^2 IV Day -7 to Day -4;
Total Body Irradiation (TBI)
2 Gy in AM of Day -3.
University of Texas MD Anderson Cancer Center, Houston
Collaborators (1)
American Stem Cell, Inc.
OTHER
National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER