Alloreactive Haploidentical Natural Killer (NK) Cells With Busulfan and Fludarabine/ATG

PHASE2CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
LeukemiaChronic Myelogenous Leukemia
Interventions
DRUG

Fludarabine

40 mg/m2 intravenous over one (1) hour on each of four (4) consecutive days, Days -13 to -10.

DRUG

Busulfan

130 mg/ m2 by vein for 2 doses on Days -11 to -10.

PROCEDURE

NK cell infusion:

Natural killer cell infusion will be administered by vein on Day -8.

DRUG

Interleukin-2

0.5 million units subcutaneously daily for 5 days on Day -8 to day -4.

DRUG

Anti-Thymocyte Globulin

2.5 mg/kg by vein for 3 doses on Days -3 to -1.

PROCEDURE

Allogeneic related Stem Cell Transplant

Allogeneic related stem cell transplant by vein on day 0.

DRUG

Tacrolimus

Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml.

DRUG

Methotrexate

5 mg/m2 by vein Days 1, 3 and 6 post transplant.

DRUG

G-CSF

5 mcg/kg/day subcutaneously beginning on Day + 7, and continuing until the absolute neutrophil count (ANC) is \> 500 x 10/L for 3 consecutive days.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

M.D. Anderson Cancer Center

OTHER

NCT01390402 - Alloreactive Haploidentical Natural Killer (NK) Cells With Busulfan and Fludarabine/ATG | Biotech Hunter | Biotech Hunter