11
Participants
Start Date
September 14, 2015
Primary Completion Date
September 22, 2020
Study Completion Date
September 22, 2021
Busulfan
Test dose Busulfan 32 mg/m2 given by vein on Day -8. Busulfan AUC 5,000 by vein on Days -6 to -3.
Fludarabine
Fludarabine 10 mg/m2 by vein on Days -6 to -3.
Clofarabine
"Salvage Chemotherapy Before Transplant: Clofarabine 15 mg/m2 by vein on Days 6 - 9.~Stem Cell Transplant: Clofarabine 40 mg/m2 by vein on Days -6 to -3."
Total Body Irradiation (TBI)
Total body irradiation (TBI) delivered at 2Gy on Day -2.
Thymoglobulin
Thymoglobulin 2.0 mg/Kg by vein on Days -3 and -2.
Stem Cell Infusion
Fresh or cryopreserved bone marrow or peripheral blood (PB) progenitor cells infused on Day 0. Goal is to infuse 4 X 106 CD34+ cells/kg if PB or \>3.0 X 108 marrow mononuclear cells/kg if bone marrow.
Cyclophosphamide
Cyclophosphamide 50 mg/kg by vein on Days +3 and +4.
Tacrolimus
Tacrolimus 0.015 mg/kg/day by vein or mouth on Day +5.
Mycophenolate mofetil
Mycophenolate mofetil 15 mg/kg/dose by vein or by mouth three times a day from Day +5 to Day+100.
Decitabine
20 mg/m2 by vein on Days 1 - 5.
Cytarabine
1 g/m2 by vein on Days 6 - 10.
Idarubicin
10 mg/m2 by vein on Days 6 - 8.
University of Texas MD Anderson Cancer Center, Houston
M.D. Anderson Cancer Center
OTHER