Hematopoietic Cell Transplantation in the Treatment of Infant Leukemia Using Double Umbilical Cord Transplantation
OBJECTIVES:
Primary
- Determine the incidence of engraftment, defined as achieving donor-derived neutrophil
count > 500/mm³ by day 42, in infants with high-risk acute myeloid leukemia, acute
lymphoblastic leukemia, or myelodysplastic syndromes treated with a non-irradiation
containing myeloablative conditioning regimen comprising busulfan, fludarabine, and
melphalan followed by double umbilical cord blood transplantation (UCBT) with two
partially HLA-matched units.
Secondary Objectives
- Determine the incidence of transplant-related mortality (TRM) at 6 months after UCBT
- Evaluate pattern of chimerism after double UCBT
- Determine the incidence of platelet engraftment at 1 year after UCBT
- Determine the incidence of acute graft-versus-host disease (GVHD) grade II-IV and grade
III-IV at day 100 after UCBT
- Evaluate the developmental outcome after UCBT
Transplant Related Objectives
- Determine the incidence of chronic GVHD at 1 year after UCBT
- Determine the survival and disease free survival at 1 and 2 years after UCBT
- Determine the incidence relapse at 1 and 2 years after UCBT
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of Engraftment
Defined as achieving donor derived neutrophil count >500/uL by day 42 in young children with leukemia or myelodysplastic syndrome treated with busulfan, melphalan and fludarabine followed by umbilical cord blood transplantation (UCBT) with two partially HLA matched units.
Day 42 After Transplant
Yes
Michael R. Verneris, MD
Principal Investigator
Masonic Cancer Center, University of Minnesota
United States: Institutional Review Board
2005LS075
NCT00357565
December 2005
August 2015
Name | Location |
---|---|
Masonic Cancer Center, University of Minnesota | Minneapolis, Minnesota 55455 |