NK Cell Based Non-Myeloablative Transplantation in Acute Myeloid Diseases

PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2017

Conditions
Acute Myeloid LeukemiaMyelodysplastic Syndrome
Interventions
DRUG

Preparative Regimen

"Preparative Regimen:~1\) fludarabine 40 mg/m\^2 x 4 doses on Days -22 through -19 pretransplant, 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pretransplant, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pretransplant,"

BIOLOGICAL

NK Cells

CD3\^- CD19\^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pretransplant.

DRUG

Interleukin-2

Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion

BIOLOGICAL

CD34 Graft/Anti-thymocyte globulin

Single donor filgrastim mobilized CD34+ selected peripheral blood stem cell graft (minimum cell dose of 5 x 10\^6/kg) on day 0. Rabbit anti-thymocyte globulin (ATG) will be administered on day -1 (0.5 mg/kg) and day +1 and +2 (2.5 mg/kg) pretransplant per institutional guidelines. ATG dosing not identical for all patients.

BIOLOGICAL

Donor TCR α/β-depleted Graft/ATG

Single donor TCR α/β-depleted filgrastim-mobilized peripheral blood stem cells (PBSC) graft (minimum cell dose of 5 x 10\^6/kg) on day 0. ATG will be administered on days -6 and -5 (3mg/kg) for most patients.

Trial Locations (4)

30322

Emory University, Atlanta

43210

Ohio State University, Columbus

55455

University of Minnesota, Masonic Cancer Center, Minneapolis

63110

Washington University, St Louis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT01370213 - NK Cell Based Non-Myeloablative Transplantation in Acute Myeloid Diseases | Biotech Hunter | Biotech Hunter