201
Participants
Start Date
April 11, 2012
Primary Completion Date
August 11, 2022
Study Completion Date
August 11, 2022
Fludarabine monophosphate
40 mg/m2 by vein on Days -6 through -3.
Busulfan
First two doses of Busulfan, 80 mg/m2 administered as an outpatient or as an inpatient to facilitate for this pharmacokinetically directed therapy. Busulfan is administered at the dose calculated to achieve a total (including first two doses delivered on day -13 and -12) systemic exposure of 20,000 ± 12% µMol-min based on the pharmacokinetic studies.
Stem Cell Infusion
Fresh or cryopreserved bone marrow or peripheral blood progenitor cells infused on Day 0.
Tacrolimus
Starting dose of 0.015 mg/kg (ideal body weight) as 24 hour continuous infusion daily adjusted to achieve therapeutic level of 5-15 ng/ml. Tacrolimus changed to oral dosing when tolerated and can be tapered off after day +90 if no graft versus host disease (GVHD) present.
Methotrexate
5 mg/m2 by vein on Days 1, 3, 6 and 11 post transplant.
G-CSF
5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is \> 500 \* 10/L for 3 consecutive days.
University of Texas MD Anderson Cancer Center, Houston
M.D. Anderson Cancer Center
OTHER