NCT01106950

Haploidentical Natural Killer Cells to Treat Refractory or Relapsed Acute Myelogenous Leukemia (AML)

Adoptive Transfer of Haploidentical Natural Killer Cells to Treat Refractory or Relapsed AML MT2010-02

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Myelogenous, Acute

Interventions

Type	Name	Description
BIOLOGICAL	Natural Killer Cells	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.
DRUG	Fludarabine	Administered as a 1 hour intravenous infusion once a day for 5 doses beginning on day -6.
DRUG	Cyclophosphamide	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.)
DRUG	Denileukin diftitox	12 ug/kg/day will be administered on day -1 and day -2 intravenously.
PROCEDURE	Donor lymphapheresis	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).
DRUG	IL-2	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).

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-10-01
• Completion: 2012-12-01
• First posted: 2010-04-20
• Last updated: 2017-12-28
• Results posted: 2013-06-26

Locations

1 site across 1 country: United States