MT2014-25: Haplo NK With SQ IL-15 in Adult Relapsed or Refractory AML Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

October 1, 2015

Primary Completion Date

December 1, 2016

Study Completion Date

December 1, 2016

Conditions
Acute Myelogenous Leukemia
Interventions
BIOLOGICAL

IL-15

"Preparative Regimen:~Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (if \< 4 months from prior transplant, omit day -4 dose)~IL-15 Activated Donor NK Cells:~The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be activated by overnight incubation with10 ng/ml IL-15 under GMP conditions and infused on day 0.~IL-15 to Facilitate NK Cell Survival and Expansion:~IL-15 at 2 mcg/kg subcutaneously (SC) beginning day +1, once a day for 5 days followed by a 2 day rest, and then once a day for 5 days for 10 doses total"

Trial Locations (1)

55455

Masonic Cancer Center at University of Minnesota, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT02395822 - MT2014-25: Haplo NK With SQ IL-15 in Adult Relapsed or Refractory AML Patients | Biotech Hunter | Biotech Hunter