304
Participants
Start Date
November 30, 2006
Primary Completion Date
October 31, 2012
Study Completion Date
October 31, 2015
Tacrolimus
"Adults and Children: Tacrolimus will be given at a dose of 0.02 mg/kg every 24 hours as a continuous intravenous infusion beginning on Day -3. An effort will be made to convert the tacrolimus to oral dosing at 2-3 times the total 24-hour intravenous dose, split into 2 doses given every 12 hours as soon as clinically feasible.~The target serum level for tacrolimus is 5-10 ng/mL."
Methotrexate
Methotrexate will be given at a dose of 15 mg/m2 on Day 1 after transplantation, and at a dose of 10 mg/m2 on Days 3, 6 and 11 after transplantation.
Sirolimus
"Adults: Sirolimus will be given in a loading dose of 12 mg on Day -3 followed by a daily oral dose of 4 mg per day. Doses may be repeated if the subject vomits within 15 minutes of an oral dose.~Children: Children aged \< 12.0 years OR weighing \< 40.0 kg will be given an oral loading dose of sirolimus of 3 mg/m2 followed by a daily oral dose of 1 mg/m2, rounded to the nearest full milligram.~The target serum level for sirolimus is 3-12 ng/mL."
Roswell Park Cancer Institute, Buffalo
University of Pittsburgh Cancer Institute, Pittsburgh
University of Pennsylvania Cancer Center, Philadelphia
Virginia Commonwealth University/MCV Hospital, Richmond
Duke University Medical Center, Durham
Emory University, Atlanta
University of Florida College of Medicine (Shands), Gainesville
Ohio State, Arthur G. James Cancer Hospital, Columbus
Indiana University Medical Center, Indianapolis
University of Minnesota, Minneapolis
Mayo Clinic, Rochester
Washington University/Barnes Jewish Hospital, St Louis
University of Oklahoma Medical Center, Oklahoma City
Texas Transplant Institute, San Antonio
City of Hope National Medical Center, Duarte
UCSD Medical Center, La Jolla
Stanford Hospital and Clinics, Stanford
Oregon Health & Science University, Portland
University of Iowa Hospitals and Clinics, Iowa City
DFCI/Brigham & Women's Hospital, Boston
University of Michigan Medical Center, Ann Arbor
University Hospitals of Cleveland/Case Western, Cleveland
University of Wisconsin Hospital & Clinics, Madison
Hopital Saint-Louis, Paris
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Blood and Marrow Transplant Clinical Trials Network
NETWORK
National Cancer Institute (NCI)
NIH
Medical College of Wisconsin
OTHER