82
Participants
Start Date
December 31, 2002
Primary Completion Date
November 30, 2006
Study Completion Date
August 31, 2010
anti-thymocyte globulin
2.5mg/kg/day IV infusion over 6 hrs x 4 doses Days -4 to -1 (for MUD and 9/10 related donor transplants only)
G-CSF
5 ug/kg/day subQ injection Day 7 until ANC\> 1000/uL for 3 consec days
busulfan
0.8mg/kg IV infusion over 2 hrs q 6 hrs x 8 doses Days -4 thru -3
fludarabine phosphate
30 mg/sq m/day IVBP over 30 min Days -7 thru -3
methotrexate
5 mg/sq m/day IV infusion Days 1, 3, \& 6 for HLA-identical donor transplants and Days 1, 3, 6, \& 11 for MUD \& 9/10 related donor transplants
mycophenolate mofetil
15mg/kg PO bid Day -2 to Day 60, then taper as tolerated (for MUD and 9/10 related donor transplants only)
tacrolimus
target serum level is 5-10 ng/mL. Start with 0.03mg/kg PO bid Day -1 to Day 90, then taper thru Day 150 for HLA identical donor transplants and Day -1 to Day 180 then taper for MUD and 9/10 related donor transplants
allogeneic cell transplantation
2,000,000-8,000,000 CD34+ cells total via infusion Days 0 and 1
allopurinol
300 mg/day PO Days -8 thru -1
CCOP - Christiana Care Health Services, Newark
St. Francis Hospital, Wilmington
Beebe Medical Center, Lewes
Union Hospital Cancer Center at Union Hospital, Elkton MD
Siteman Cancer Center at Barnes-Jewish Hospital, St Louis
Rebecca and John Moores UCSD Cancer Center, La Jolla
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees, Voorhees Township
Roswell Park Cancer Institute, Buffalo
Wake Forest University Comprehensive Cancer Center, Winston-Salem
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh
Massey Cancer Center at Virginia Commonwealth University, Richmond
National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER