Haploidentical Donor NK Cell Adoptive Therapy and Double T Cell Depleted Umbilical Cord Blood Transplantation With Post-Transplant IL-2 Immune Therapy For Refractory Acute Myeloid Leukemia
- 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.
- 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
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Neutrophil Engraftment
Number of patient with absolute neutrophils >500*10^8/kg by 42 days post transplant.
Michael R. Verneris, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|University of Minnesota Children's Hospital - Fairview||Minneapolis, Minnesota 55455|