Myeloablative Allogeneic Stem Cell Transplantation Using a Naive T-Cell Depleted Peripheral Blood Stem Cell Graft
A cohort of patients (Cohort 1) will be enrolled to receive the currently accepted standard
approach to myeloablative allogeneic stem cell transplantation. With the exception of
volume and/or plasma depletion (in cases of donor/recipient ABO incompatibility), the
peripheral blood stem cell graft will be unmodified. The primary purpose of Cohort 1 is to
prospectively collect samples for measurement of immune recovery from a relatively
homogeneous population of patients treated in a uniform manner. Within the limitations of
age-matching, patients accrued to Cohort 1 will be incorporated into a larger retrospective
historical control group for purposes of comparison with Cohort 2 of the incidence of grade
II-IV acute Graft versus Host disease. The experimental aspects of this trial will be the
use of a naïve T-cell depleted peripheral blood stem cell graft (Cohort 2). All other
aspects of this stem cell transplantation are in line with the standard of care.
Recruitment to this trial will be stratified by donor type as matched sibling or matched
unrelated donor. Patients will be conditioned with total body irradiation (1350cGy) and
Cyclophosphamide. The donor stem cell grafts will come from mobilized peripheral blood of
6/6 HLA-identical family members or 8/8 (HLA A, B, C, DRB1) allele-level matched unrelated
donors.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The incidence of grade II/IV acute graft versus host disease and one year disease-free survival.
One year
Yes
Mitchell Horwitz, MD
Principal Investigator
Duke University Health System
United States: Food and Drug Administration
Pro00000993
NCT00814983
July 2007
July 2017
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