Donor Natural Killer Cells and Aldesleukin in Treating Patients w/High Risk AML Undergoing Donor Stem Cell Transplant

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions
Acute Myelogenous Leukemia
Interventions
BIOLOGICAL

aldesleukin

Administered subcutaneously (SQ) 9 million units every other day beginning Day -12 through -2 (evening of natural killer cell infusion) for a total of 6 doses.

BIOLOGICAL

natural killer cells

Infusion given on Day -12; The targeted infused cell dose of CD3- CD19- selected NK product is within the range of 2-3 x 10\^7 cells/kg.

DRUG

cyclophosphamide

Administered intravenously (IV) 50 mg/kg on Day -15

DRUG

fludarabine phosphate

Administered intravenously (IV) 40 mg/m\^2 on Days -18 through -14

PROCEDURE

allogeneic hematopoietic stem cell transplantation

On day 0, patients will receive an allogeneic transplant using pool cells from the day -1 and day 0 PBSC which will be CD34+ selected as the donor graft. The graft will be infused over 15-60 minutes.

RADIATION

total body irradiation

Administered on Day -13, 200 cGy two times.

BIOLOGICAL

Thymoglobulin

intravenous (IV) 3 mg/kg on Day 0 (day of donor CD34 cell infusion)

DRUG

Cyclosporin A

1.5 mg/kg by mouth or intravenously for target dose range of 150-250; day -15 through day -8.

DRUG

cyclophosphamide

Administered intravenously (IV) 50 mg/kg on Days -16 and -15

DRUG

fludarabine phosphate

Administered intravenously (IV) 35 mg/m\^2 on Days -18 through -14

Trial Locations (1)

55455

Masonic Cancer Center, University of Minnesota, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT00303667 - Donor Natural Killer Cells and Aldesleukin in Treating Patients w/High Risk AML Undergoing Donor Stem Cell Transplant | Biotech Hunter | Biotech Hunter