15
Participants
Start Date
November 30, 2003
Primary Completion Date
September 30, 2009
Blood stem cell versus bone marrow transplant
"1. Cyclophosphamide and Total Body Irradiation (CY-TBI)-based regimens that include at least 120 mg/kg cyclophosphamide and at least 1200 cGy of fractionated TBI.~2. Busulfan and cyclophosphamide (BU-CY)-based regimens that include at least 14 mg/kg busulfan orally or 11.2 mg/kg busulfan intravenously (14 x 0.8 correction factor) or a targeted busulfan dosing strategy aimed at a serum concentration greater than 600 ng/mL at steady state and at least 120 mg/kg cyclophosphamide.~3. Fludarabine and melphalan (Flu-Mel)-based regimens that include a fludarabine dose of least 120 mg per m2 and a melphalan dose of at least 140 mg per m2.~4. Fludarabine, busulfan, and ATG (Flu-Bu-ATG)-based regimens that include a fludarabine dose of at least 120 mg/m2, at least 8 mg/kg busulfan orally or 250 mg/m2 busulfan intravenously, and at least 40 mg/kg equine ATG or 4 mg/kg rabbit ATG. Institutional standards should be followed for targeting plasma levels."
Mayo Clinic, Rochester
Lead Sponsor
Collaborators (1)
National Institutes of Health (NIH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Cancer Institute (NCI)
NIH
National Marrow Donor Program
OTHER
University of Minnesota
OTHER
University of Florida
OTHER
Duke University
OTHER
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Mayo Clinic
OTHER