Donor Natural Killer Cells in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Inclusion Criteria:

1. Patients with relapsed or primary refractory AML. Patients with relapsed AML after
allogeneic stem cell transplantation, including those who have received donor
lymphocyte infusions, are eligible if they have no active GvHD and are off
immunosuppression.

2. Have a haploidentical family peripheral blood donor selected for best possible KIR
reactivity. KIR typing will not be indicated if there is only one haploidentical
donor. KIR typing is advised to be done if feasible and does not delay transplant.

3. Patient age >/= 18 years old.

4. Performance status: Karnofsky or Lansky Performance Scale (PS) greater or equal to 70.

5. Renal function: Serum creatinine than 40 cc/min. Creatinine for pediatric patients of normal for age (whichever is less).

6. Pulmonary function: FEV1, FVC and DLCO >/=50% of expected, corrected for hemoglobin.
For pediatric patients, if unable to perform pulmonary function tests (most children <
7 years of age), pulse oximetry >/= 92% on room air by pulse oximetry.

7. Liver function: Total bilirubin syndrome) and SGPT (ALT)
8. Cardiac function: left ventricular ejection fraction >/= 40%. No uncontrolled
arrhythmias or uncontrolled symptomatic cardiac disease.

9. Negative serum test to rule out pregnancy within 2 weeks prior to registration in
females of childbearing potential (non childbearing potential defined as premenarchal,
greater than one year post-menopausal, or surgically sterilized).

10. Sexually active males and females of childbearing potential must agree to use a form
of contraception considered effective and medically acceptable by the Investigator.

11. Negative serology for human immunodeficiency virus (HIV).

12. Donor Eligibility Criteria and Evaluation Prior to Donation: Donor must be 16 years of
age or older and weigh at least 110 pounds.

13. Donor must be an HLA-haploidentical relative selected for best NK alloreactivity,
defined as having a KIR gene present on the Donor NK cells for which the relevant HLA
haplotype (KIR ligand) is absent in the Recipient and present in the Donor or selected
on the basis of activating KIR gene content.

14. Donor must meet standard institutional eligibility and donor certification criteria
for therapeutic cell product donation.

15. Not be pregnant as defined by negative serum (beta HCG) pregnancy test in females of
childbearing potential (Non-childbearing potential defined as premenarchal, previous
surgical sterilization, or postmenopausal for >12 months.

16. Evaluation: History and physical examination. Laboratory examinations: hematology,
electrolytes, chemistry. Infectious disease screening and serology. HLA typing. KIR
typing will not be indicated if there is only one haploidentical donor. KIR typing is
advised to be done if feasible and does not delay transplant.

Exclusion Criteria:

1. Congestive heart failure <6 months prior to screening.

2. Unstable angina pectoris <6 months prior to screening.

3. Myocardial infarction <6 months prior to screening.

4. Uncontrolled infection, defined as an infection which has not resolved spontaneously
or does not show evidence of significant resolution after initiating appropriate
therapy, excluding chronic asymptomatic viral infections (e.g., HPV, BK virus, HCV,
etc.).