313
Participants
Start Date
December 8, 2023
Primary Completion Date
February 1, 2026
Study Completion Date
June 30, 2026
Busulfan
Given IV or PO pre-transplant as part of conditioning regimen
Fludarabine
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
Post-Transplant Cyclophosphamide
"Cyclophosphamide (25mg/kg) is administered on Day 3 and Day 4 post-transplant as an IV infusion over 1-2 hours.~First 20 subjects with a 4-6/8 HLA mismatched unrelated donor will receive an intermediate dose of post-transplant cyclophosphamide of 37.5 mg/kg Day 3 and Day 4 post-transplant."
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 Day + 90 and finished by Day +180.
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 transplant, at Day + 100, Day + 180, and Day +365 post transplant.
Melphalan
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
RECRUITING
Memorial Sloan Kettering Cancer Center - Adults, New York
RECRUITING
University of Pittsburgh Medical Center, Pittsburgh
RECRUITING
The Center for Bone Marrow Transplantation at Geisinger, Danville
RECRUITING
Abramson Cancer Center, Philadelphia
RECRUITING
Greenbaum Cancer Center University of Maryland, Baltimore
RECRUITING
University of Virginia Health System, Charlottesville
RECRUITING
University of North Carolina, Chapel Hill
RECRUITING
Emory University, Atlanta
RECRUITING
Mayo Clinic Jacksonville, Jacksonville
RECRUITING
University of Miami Sylvester Cancer Center, Miami
RECRUITING
Moffitt Cancer Center, Tampa
RECRUITING
TriStar Centennial, Nashville
RECRUITING
Ohio State Medical Center, Columbus
RECRUITING
Karmanos Cancer Institute, Detroit
RECRUITING
Froedtert & the Medical College of Wisconsin, Milwaukee
RECRUITING
University of Minnesota, Minneapolis
RECRUITING
Mayo Clinic, Rochester
RECRUITING
Barnes Jewish Hospital / Washington University, St Louis
RECRUITING
University of Arkansas for Medical Sciences, Little Rock
RECRUITING
MD Anderson Cancer Center, Houston
RECRUITING
Methodist Hospital San Antonio, San Antonio
RECRUITING
St. David's South Austin Medical Center, Austin
RECRUITING
Colorado Blood Cancer Institute at Presbyterian St. Luke's, Denver
RECRUITING
Mayo Clinic Arizona, Phoenix
RECRUITING
Honor Health, Scottsdale
RECRUITING
City of Hope, Duarte
RECRUITING
University of California San Francisco, San Francisco
RECRUITING
Stanford University, Stanford
RECRUITING
Oregon Health & Science University, Portland
RECRUITING
Fred Hutchinson Cancer Center, Seattle
RECRUITING
Tufts University, Boston
RECRUITING
Dana Farber Cancer Institute, Boston
National Marrow Donor Program
OTHER
Center for International Blood and Marrow Transplant Research
NETWORK