Allogeneic Natural Killer Cells in Patients With Relapsed Acute Myelogenous Leukemia
- Evaluate the in vivo expansion of natural killer (NK) cells 14 days after treatment
with allogeneic NK cell-enriched peripheral blood stem cell transplantation in patients
with relapsed acute myeloid leukemia.
- Determine the response rate, in terms of complete remission, in patients treated with
- Correlate complete remission rate with NK cell expansion, interleukin-15 levels, and
donor/recipient killer immunoglobulin receptor (KIR) ligand matching status in patients
treated with this regimen.
- Determine the overall and progression-free survival of patients treated with this
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is an open-label study.
- Induction therapy: Patients receive fludarabine IV on days -6 to -2 and
cyclophosphamide IV on day -5 or on days -5 and -4.
- Allogeneic natural killer (NK) cell-enriched peripheral blood stem cell
transplantation: Patients receive allogeneic NK cell-enriched peripheral blood stem
cells IV over 15-60 minutes on day 0. Patients also receive interleukin-2
subcutaneously beginning on day 0 and continuing 3 times a week for up to 2 weeks.
After completion of study treatment, patients are followed periodically for 3 months.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Natural Killer (NK) Cell Expansion
Evaluation of expansion of donor allogeneic natural killer (NK) cells at day 14 following infusion (>100 donor-derived NK cells per uL of patient blood detectable at day +14).
Study Day 14
Jeffrey Miller, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center||Minneapolis, Minnesota 55455|