202
Participants
Start Date
April 15, 1999
Primary Completion Date
December 14, 2018
Study Completion Date
June 18, 2020
T-cell replete PBPC allograft
Subjects will receive a non-myeloablative preparative regimen of cyclophosphamide 60mg/kg/d x 2 days, and fludarabine 25mg/m2 intravenously (IV) over 30 minutes daily x 5 days with or without ATG followed by a PBPC graft targeted to deliver \>5x10\^6 CD34+ cells/kg.
Methotrexate
IV MTX on days +1, +3, and +6 will be given
Cyclosporine
CSA will be given beginning on day -4 for graft versus host disease prophylaxis. Participants with mixed T-cell chimerism on day 30 will begin a CSA taper. Participants with 100% donor T-cell chimerism by day 30 will be tapered off CSA from days 60 through 100 (25% reduction in dose every 10 days-off by day 100). CSA will not be tapered in any subjects with grade \> II acute GVHD regardless of chimerism results. In addition, participants with evidence of disease progression without grade \> II GVHD will have CSA discontinued regardless of chimerism results.
G-CSF
G-CSF will be administered based on body weight for at least 5, and up to 7 days, subcutaneously.
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda
National Heart, Lung, and Blood Institute (NHLBI)
NIH