95
Participants
Start Date
October 3, 2017
Primary Completion Date
January 29, 2025
Study Completion Date
January 29, 2025
Haploidentical Bone Marrow Transplantation
Eligible patients with a first degree Human Leukocyte Antigen (HLA)- haploidentical donor will undergo Haploidentical bone marrow transplantation at Day 0 with non T-cell depleted bone marrow. For Graft-vs-Host Disease (GVHD) prophylaxis, patients will be given sirolimus and mycophenolate mofetil beginning on Day +5.
Hydroxyurea
HU will be given daily at 30mg/kg from Day -70 through Day -10.
Rabbit-ATG
Rabbit-ATG (rATG) will be given at 0.5mg/kg on Day -9, and at 2.0mg/kg on Day -8 and Day -7.
Thiotepa
Thiotepa will be given at 10mg/kg on Day -7
Fludarabine
Fludarabine will be given at 30mg/m2 from Day -6 to Day -2
Cyclophosphamide
Cyclophosphamide will be given at 14.5mg/kg on Day -6 and Day -5, and at 50 mg/kg on Days +3 and +4.
Total Body Irradiation
Total Body Irradiation will be given at 200cGy on Day -1
Mesna
Mesna will be given at 40mg/kg on Days +3 and +4
Northwell Health/Monter Cancer Center, Lake Success
Roswell Park Cancer Center, Buffalo
University of Pittsburgh, Pittsburgh
Children's National Medical Center, Washington D.C.
Johns Hopkins University, Baltimore
Duke University Medical Center, Durham
Levine Children's Hospital, Charlotte
Northside Hospital, Atlanta
University of Florida College of Medicine, Gainesville
Nicklaus Children's Hospital/University of Miami Children's Hospital, Miami
H. Lee Moffitt Cancer Center, Tampa
University of Alabama at Birmingham, Birmingham
Vanderbilt University Medical Center, Nashville
Methodist Healthcare/West Cancer Center, Memphis
St. Jude Children's Research Hospital, Memphis
University Hospitals of Cleveland/Case Western, Cleveland
Cleveland Clinic Foundation, Cleveland
Riley Children's Hospital at IU Health, Indianapolis
Indiana University Medical Center, Indianapolis
Children's Hospital of Michigan, Detroit
Helen Devos Children's at Spectrum Health, Grand Rapids
The Medical College of Wisconsin, Wauwatosa
Cardinal Glennon Children's Hospital, St Louis
Washington University, St. Louis, St Louis
Texas Children's Hospital (Baylor), Houston
University of Texas/MD Anderson Cancer Center, Houston
Texas Transplant Institute, San Antonio
University of Colorado - Denver/Children's Hospital of Colorado, Aurora
UCSF Benioff Children's Hospital Oakland, Oakland
Fred Hutchinson Cancer Research Center, Seattle
Hackensack University Medical Center, Hackensack
Nationwide Children's Hospital, Columbus
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