24
Participants
Start Date
August 1, 1995
Primary Completion Date
December 31, 2002
Study Completion Date
December 31, 2002
Filgrastim
Subcutaneously (SQ) daily every 12 hours starting 2-4 days prior to the first stem cell collection and before DAC infusion.
Busulfan
Administered orally every 6 hours on consecutive days -6 through -4.
Cyclophosphamide
Given intravenously (IV) over 1 hour on consecutive days -3 and -2.
Cyclosporine
Patients intolerant to tacrolimus receive cyclosporine IV beginning on day -2, then orally following tolerance and engraftment.
Decitabine (DAC)
IV over 4 hours on days -8 and -7.
Methotrexate
Given intrathecally or intraventricularly monthly, beginning on the second month through the eighth month of treatment.
Methylprednisolone
Given according to clinical grade of GVHD procedures.
Tacrolimus
IV beginning one day before stem cell infusion, then orally following tolerance to tacrolimus.
Allogeneic Bone Marrow Transplantation
Infusion of stem cells on Day 0.
Peripheral Blood Stem Cell Transplantation
Stem cell infusion on Day 0.
University of Texas - MD Anderson Cancer Center, Houston
National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER