Alloreactive NK Cells for Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions
Myelodysplastic SyndromeLeukemia
Interventions
DRUG

Thymoglobulin

1.5 mg/kg By Vein Daily x 3 Days

DRUG

Busulfan

130 mg/m\^2 By Vein Over 3 Hours x 4 Days

DRUG

Fludarabine

40 mg/m\^2 By Vein Over 30 Minutes x 4 Days

PROCEDURE

Alloreactive NK Infusion

Alloreactive NK infusion from haploidentical donor on Day -8. The alloreactive NK cell infusion given at one of 4 dose levels 10e6, 5 x 10e6, 3 x 10e7 cells/kg and 3 x10e7.

DRUG

G-CSF

5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is \> 500 x 109/L for 3 consecutive days.

DRUG

Tacrolimus

Starting dose of 0.015 mg/kg as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Tacrolimus changed to oral dosing when tolerated and can be tapered off after Day +90 if no GVHD is present.

DRUG

Methotrexate

5 mg/m2 intravenously on Days 1, 3 and 6 and Day +11 post transplant.

DRUG

Interleukin-2

0.5 million units per day subcutaneously starting on Day -8 (day of the NK cell infusion) to Day -4 only to participants receiving fourth dose level of NK cells.

Trial Locations (1)

77030

UT MD Anderson Cancer Center, Houston

All Listed Sponsors
lead

M.D. Anderson Cancer Center

OTHER

NCT00402558 - Alloreactive NK Cells for Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) | Biotech Hunter | Biotech Hunter