32
Participants
Start Date
July 3, 2017
Primary Completion Date
August 17, 2021
Study Completion Date
August 17, 2021
Antithymocyte Globulin (ATG)
Administration of ATG will be 0.5 mg/kg IV on Day -9 over 6 hours and 2 mg/kg IV on Days -8 and -7 over 4 hours.
Fludarabine
Fludarabine dose will be 30 mg/m\^2 IV daily for 5 days from Day -6 to Day -2.
Cyclophosphamide
Cyclophosphamide dose will be 14.5 mg/kg IV daily for 2 days (Day -6 to Day -5) prior to transplantation and 50 mg/kg IV daily for 2 days (Day +3 to Day +4) after transplantation.
Total Body Irradiation (TBI)
TBI is to be delivered in a single dose of 200 cGy on Day -1.
Haplo HSCT
Eligible patients without a fully matched related or unrelated donor available will undergo haploidentical bone marrow transplant.
Tacrolimus
Tacrolimus should be started on Day +5 and administered to maintain a level of 10-15 ng/mL.
Mycophenolate mofetil (MMF)
MMF dose will be 15 mg/kg PO three times a day (TID) up to 1 gm TID (or IV equivalent) starting on Day +5.
G-CSF
G-CSF will be given IV or SQ starting on Day +5 at 5 mcg/kg/day until ANC is \> 1500 for 3 days.
Roswell Park Cancer Institute, Buffalo
Penn State College of Medicine/The Milton S. Hershey Medical Center, Hershey
University of Pennsylvania Cancer Center, Philadelphia
Children's National Medical Center, Washington D.C.
Johns Hopkins Unversity, Baltimore
Duke University Medical Center, Durham
Northside Hospital, Atlanta
University of Florida College of Medicine, Gainesville
Miami Children's Hospital, Miami
H. Lee Moffitt Cancer Center, Tampa
All Children's Hospital, St. Petersburg
University of Louisville/Kosair Children's Hospital, Louisville
Indiana University Medical Center/ Riley Hospital for Children, Indianapolis
University of Michigan Medical Center, Ann Arbor
Karmanos Cancer Institute/Children's Hospital of Michigan, Detroit
Children's Hospital of Wisconsin/Midwest Children's Cancer, Milwaukee
Washington University/Barnes Jewish Hospital, St Louis
Children's Mercy Hospital and Clinics, Kansas City
Baylor College of Medicine, Houston
University of Texas/MD Anderson Cancer Center, Houston
Texas Transplant Institute, San Antonio
Children's Hospital of Los Angeles, Los Angeles
City of Hope National Medical Center, Duarte
Stanford Hospital and Clinics, Stanford
Children's Hospital and Research Center Oakland, Oakland
Fred Hutchinson Cancer Research Center, Seattle
Hackensack University Medical Center, Hackensack
Oregon Health and Science University, Portland
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