300
Participants
Start Date
September 30, 2021
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
Busulfan
Given IV or PO pre-transplant as part of conditioning regimen
Busulfan
Given IV pre-transplant as part of conditioning regimen
Fludarabine
Given IV pre-transplant as part of conditioning regimen
Total-body irradiation
Administered pre-transplant as part of conditioning regimen
Cyclophosphamide
Given IV pre-transplant as part of conditioning regimen
Melphalan
Given IV pre-transplant as part of conditioning regimen
PBSC Hematopoietic Stem Cell Transplantation (HSCT)
Peripheral blood stem cell graft is infused from a mismatched unrelated donor on Day 0.
Bone Marrow Hematopoietic Stem Cell Transplantation
Bone marrow graft is infused from a mismatched unrelated donor on Day 0.
Post-transplant Cyclophosphamide
Cyclophosphamide (50 mg/kg) is administered on Day +3 and on Day +4 post-transplant as an IV infusion over 1-2 hours.
Mesna
Mesna is given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide.
Tacrolimus
Tacrolimus is given at a dose of 0.05 mg/kg PO or an IV dose of 0.03 mg/kg of ideal body weight (IBW) starting on Day +5 post-transplant with taper recommended at 90-100 days post HCT.
Mycophenolate Mofetil
Mycophenolate mofetil (MMF) is given at a dose of 15 mg/kg three times daily IV or PO from Day +5 to Day +35 post-transplant.
Patient-Reported Outcomes
Survey assessments will be administered to study participants pre- and post-transplant.
Columbia University Medical Center, New York
Memorial Sloan Kettering Cancer Center, New York
Roswell Park Comprehensive Cancer Center, Buffalo
University of Pennsylvania, Philadelphia
Thomas Jefferson University Sidney Kimmel Cancer Center, Philadelphia
University of Maryland Medical Center, Baltimore
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore
University of Virginia, Charlottesville
Virginia Commonwealth University, Richmond
University of North Carolina Chapel Hill, Chapel Hill
Medical University of South Carolina, Charleston
Children's Healthcare of Atlanta, Atlanta
Emory University Medical Center, Atlanta
University of Florida Health Shands Hospital, Gainesville
University of Miami Sylvester Cancer Center, Miami
H. Lee Moffitt Cancer Center and Research Institute, Tampa
TriStar BMT, Nashville
TriStar Medical Group Children's Specialists, Nashville
Texas Transplant Institute, San Antonio
Vanderbilt University Medical Center, Nashville
Ohio State Medical Center, James Cancer Center, Columbus
Cincinnati Children's Hospital, Cincinnati
University of Michigan Medical Center - Mott Children's Hospita, Ann Arbor
Karmanos Cancer Institute, Detroit
Froedtert & the Medical College of Wisconsin, Milwaukee
University of Wisconsin Hospital and Clinic, Madison
Mayo Clinic Rochester, Rochester
Northwestern University, Chicago
The University of Chicago, Chicago
Washington University/Barnes Jewish Hospital, St Louis
-Baylor College of Medicine - Texas Children's Hospital and Houston Methodist, Houston
St. David's South Austin Medical Center, Austin
Colorado Blood Cancer Institute, Denver
City of Hope National Medical Center, Duarte
University of California San Francisco, San Francisco
Stanford University, Stanford
Oregon Health and Science University, Portland
Tufts Medical Center, Boston
Dana Farber Cancer Institute, Boston
National Marrow Donor Program
OTHER
Center for International Blood and Marrow Transplant Research
NETWORK