127
Participants
Start Date
October 31, 2016
Primary Completion Date
August 17, 2018
Study Completion Date
February 19, 2019
Sirolimus
Sirolimus will be administered with a starting dose of 6 mg for patients older than 12 years, or 5 mg/m\^2 for patients ≤ 12 years. Trough levels will be routinely measured and sirolimus will be kept at maintenance dosing for target therapeutic levels for minimum duration through Day 56 post-randomization.
Prednisone
Prednisone will be administered at 2mg/kg/day x 3 days, and then tapered according to individual treating clinician judgment.
Icahn School of Medicine at Mount Sinai, New York
Virginia Commonwealth University MCV Hospitals, Richmond
Duke University Medical Center, Durham
Children's Healthcare of Atlanta, Atlanta
Emory University, Atlanta
Blood & Marrow Transplant Program at Northside Hospital, Atlanta
University of Florida College of Medicine (Shands), Gainesville
H. Lee Moffitt Cancer Center, Tampa
Vanderbilt University Medical Center, Nashville
Ohio State/Arthur G. James Cancer Hospital, Columbus
Cleveland Clinic Foundation, Cleveland
University of Michigan Medical Center, Ann Arbor
Medical College of Wisconsin, Milwaukee
University of Minnesota, Minneapolis
Mayo Clinic Rochester, Rochester
Washington University/Barnes Jewish Hospital, St Louis
University of Kansas Hospital, Kansas City
University of Texas/MD Anderson Cancer Center, Houston
Children's Hospital Los Angeles, Los Angeles
City of Hope National Medical Center, Duarte
Fred Hutchinson Cancer Research Center, Seattle
National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Cancer Institute (NCI)
NIH
Blood and Marrow Transplant Clinical Trials Network
NETWORK
National Marrow Donor Program
OTHER
Medical College of Wisconsin
OTHER