224
Participants
Start Date
December 31, 2006
Primary Completion Date
March 31, 2014
Study Completion Date
October 31, 2014
Single Umbilical Cord Blood Unit Transplant
Unrelated donor, single umbilical cord blood unit; conditioning regimen: TBI/cyclophosphamide/fludarabine; GVHD prophylaxis: cyclosporine/MMF
Double Umbilical Cord Blood Unit Transplant
Unrelated donor, double umbilical cord blood unit; Conditioning regimen: TBI/cyclophosphamide/fludarabine; GVHD prophylaxis: cyclosporine/MMF
Total Body Irradiation
The TBI will be delivered from either a linear accelerator or cobalt source at a dose rate of between 4 and 26 cGy/minute using energies of between 1 and 25 MV.
Cyclophosphamide
Cyclophosphamide 60 mg/kg/day will be administered as a 2 hour intravenous infusion with a high volume fluid flush on Days -3 and -2.
Fludarabine
Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days -10 through -8. Fludarabine will not be dose adjusted for body weight.
Cyclosporine A
CSA will be administered beginning on Day -3 and doses will be adjusted to maintain a level of 200-400 ng/mL by TDX method (or 100-250 ng/mL by Tandem MS or equivalent level for other CSA testing methods). CSA can be administered per institutional practice.
Mycophenolate Mofetil
MMF will be given at a dose of 1 gram IV q 8 hours if \> 50 kg or 15 mg/kg IV q 8 hours if \< 50 kg beginning the morning of Day -3.
Children's Hospital at Westmead, Westmead
New York Medical College, Valhalla
Children's Hospital of Philadelphia, Philadelphia
Children's National Medical Center, Washington D.C.
Virgina Commonwealth University, Richmond
Duke University Medical Center, Durham
Medical University of South Carolina, Charleston
Nemours Childrens Clinic, Jacksonville
University of Florida College of Medicine (Shands), Gainesville
University of Miami, Miami
All Children's Hospital, St. Petersburg
University of Alabama, Birmingham
University of Mississippi, Jackson
University of Louisville/Kosiar Children's Hospital, Louisville
Indiana University Medical Center, Indianapolis
University of Michigan Medical Center, Ann Arbor
Karmanos Cancer Institute/Children's Hospital of Michigan, Detroit
Medical College of Wisconsin, Milwaukee
University of Minnesota, Minneapolis
Children's Mercy Hospital and Clinics, Kansas City
Children's of New Orleans, New Orleans
Children's Medical Center of Dallas, Dallas
Cook Childrens Medical Center, Fort Worth
Texas Transplant Institute, San Antonio
The Children's Hospital of Denver, Denver
Utah BMT/University of Utah Medical School, Salt Lake City
Phoenix Children's Hospital, Phoenix
City of Hope National Medical Center, Duarte
UCSD/Rady Childrens Hospital, San Diego
University of California, San Francisco (Peds), San Francisco
Childrens Hospital at Oakland, Oakland
Oregon Health Sciences University, Portland
Fred Hutchinson Cancer Research Center, Seattle
Children's Healthcare of Atlanta, Atlanta
DFCI/Children's Hospital of Boston, Boston
Nationwide Children's Hospital, Columbus
Vanderbilt University Medical Center, Nashville
BC Cancer Agency, Vancouver
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Blood and Marrow Transplant Clinical Trials Network
NETWORK
National Cancer Institute (NCI)
NIH
National Marrow Donor Program
OTHER
Medical College of Wisconsin
OTHER