60
Participants
Start Date
November 30, 2001
Primary Completion Date
June 30, 2006
Study Completion Date
February 28, 2010
filgrastim
PBSC collection: 10 ug/kg/d subQ inj D 5 until completion of collection Auto transpl: 5 ug/kg/d subQ inj D 5 until ANC \>= 1500/uL for 2d or 5000/uL for 1 d Allo transpl: 5ug/kg/d subQ inj D 7 until ANC \> 1000/uL for 3 days Donor pheresis: 10ug/kg/d subQ inj d -5 thru -2
CD34+ cells
2-8,000,000/kg IV infusion allogeneic transplant 2,000,000/kg IV infusion autologous transplant
cyclophosphamide
4g/sq m IV infusion over 1-2 hrs D 1 for auto, and 1g/sq m/d IV infusion over 1 hr on D -4 thru -3 for allo, transplant prep
fludarabine phosphate
30mg/sq m/d IVPB over 30 min d -7 thru -3 allo transpl
melphalan
200mg/sq m IV infusion over 15-30 min D 2 auto transpl
methotrexate
5mg/sq m/d IV infusion D 1,3,\& 6: allo transpl
tacrolimus
0.03mg/kg PO bid starting dose, D -1 thru +90, then taper thru D +150
Mount Sinai Medical Center, New York
CCOP - Christiana Care Health Services, Newark
Tunnell Cancer Center at Beebe Medical Center, Lewes
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington D.C.
Union Hospital Cancer Program at Union Hospital, Elkton MD
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis, St Louis
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco
University of Chicago Cancer Research Center, Chicago
Holden Comprehensive Cancer Center at University of Iowa, Iowa City
Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees Township
Roswell Park Cancer Institute, Buffalo
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill
Wake Forest University Comprehensive Cancer Center, Winston-Salem
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital, Pittsburgh
National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER