Finding studies
Finding studies
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Lead
Masonic Cancer Center, University of Minnesota
OBJECTIVES: Primary * To determine the rate of neutrophil engraftment and grade III-IV acute graft-versus-host disease (GVHD) following a T cell depleted (TCD) umbilical cord blood (UCB) transplantation without post-transplant immunosuppression followed by administration of interleukin-2 (IL-2, aldesleukin) (every other day) days +3 to +13 to expand NK cells in vivo. Secondary * To evaluate the safety of this regimen as assessed by monitoring the rates of graft failure, acute GVHD, and transplant-related mortality (TRM). * To perform quantitative, phenotypic, and functional assessments of the in vivo expanded UCB-derived NK cells on (day +72). * To assess clinical disease response (leukemia clearance and complete remission) and survival duration in these patients. * To evaluate the tolerability of aldesleukin in these patients. * To evaluate the tolerance of IL-2 OUTLINE: * Preparative regimen: Patients receive fludarabine phosphate intravenously (IV) over 1 hour on days -7 to -5 and cyclophosphamide IV on days -7 and -6. Patients undergo total-body irradiation twice daily on days -5 to -2. * Transplantation: Patients undergo T-cell depleted umbilical cord blood (UCB) transplantation on day 0. * IL-2 (Aldesleukin) therapy: Patients receive aldesleukin subcutaneously on days +3 6 doses every other day) and +60 (6 doses every other day). Patients are followed periodically for up to 2 years after transplant.
Age
0–45
Sex
ALL
Healthy volunteers
Not accepted
