Conditions: Leukemia, Myelogenous, Acute
Keywords: acute myelogenous leukemia primary acute myelogenous leukemia secondary acute myelogenous leukemia relapsed acute myelogenous leukemia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 15
Healthy volunteers: no

Brief summary:
This is a phase II therapeutic study of related donor HLA-haploidentical NK-cell based therapy after a high dose of fludarabine/cyclophosphamide with denileukin diftitox preparative regimen for the treatment of poor prognosis acute myelogenous leukemia (AML).

Detailed description:
Patients achieving a complete remission and neutrophil recovery (ANC \> 500) for at least 4 weeks will be considered for allogeneic transplant to prolong remission (independent of this study).

All patients, including those who go on to transplant, will be followed to determine disease free survival, treatment related mortality, and time to relapse.

Arms:
arm 1: Patients are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.

Interventions: intervention 1: Natural Killer Cells intervention 2: Fludarabine intervention 3: Cyclophosphamide intervention 4: Denileukin diftitox intervention 5: Donor lymphapheresis intervention 6: IL-2
Intervention descriptions: intervention 1: Given by infusion on Day 0. The product is T cell-depleted (CD3-) and B cell-depleted (CD19). Target dose for infusion is \< or = 8 x 10\^7 nucleated cells/kilogram. intervention 2: Administered as a 1 hour intravenous infusion once a day for 5 doses beginning on day -6. intervention 3: Administered as a 2 hour intravenous infusion with high volume fluid flush and mesna per institutional guidelines on day -5 and -4 one hour after fludarabine infusion. (Day -4 administration may be omitted if patient has had a transplant in the previous 4 months.) intervention 4: 12 ug/kg/day will be administered on day -1 and day -2 intravenously. intervention 5: Day -1 before planned NK cell infusion, the donor will undergo lymphapheresis (Removal of lymphocytes from donated blood, with the remainder of the blood retransfused into the donor). intervention 6: Administered after NK cell infusion, 10 million units every other day for a total of 6 doses. (Patients weighing less than 45 kilograms will receive a dose of 5 million units/m\^2 every other day for 6 doses).

Protocol document: