CD3-/CD19- vs CD3-/CD56+ Haplo NK for AML Pts Who Failed 1-2 Inductions

Inclusion Criteria:

- Newly diagnosed with acute myelogenous leukemia (except acute promyelocytic leukemia)
and has failed one or two prior standard induction attempts. Failure is defined as:

- ≥ 30% bone marrow blasts in a bone marrow with at least 20% cellularity at
mid-cycle bone marrow biopsy or

- residual AML on ~ day 28 bone marrow biopsy by morphology, flow, PCR or FISH

- AML that progressed out of myelodysplastic syndrome (MDS) is eligible if the patient
did not receive treatment directed at the MDS.

- Patients enrolling after only 1 failed induction attempt must meet at least one of the
following additional eligibility criteria of high risk:

- ≥ 60 years of age

- adverse cytogenetics or molecular characteristics

- (inv(3)(q21q26.2) or t(3;3)(q21;q26.2); RPN1-EVI1

- t(6;9)(p23;q34); DEK-NUP214

- t(v;11)(v;q23); MLL rearranged

- -5 or del(5q); -7; abnl(17p); complex karyotype

- Persons receiving a "non-standard" induction (i.e. one containing investigational
agent(s)) will be considered for eligibility by Miltenyi on a case by case basis.

- Use of hydroxyurea is permitted to control blasts until the day chemotherapy is
started.

- A history of AML related CNS involvement is allowed if most recent CSF analysis is
negative at least 2 weeks prior to study treatment.

- ≥ 18 and <75 years of age

- Karnofsky performance status ≥ 60% (appendix IV)

- HLA-haploidentical related donor (aged 12 to 70 years) with donor/recipient match
based on a minimum of intermediate resolution DNA based Class I typing of the A,B and
C locus - refer to section 5 for donor selection.

- Adequate organ function within 14 days of study registration (30 days for pulmonary
and cardiac) defined as:

- Creatinine: ≤ 2.0 mg/dL

- Hepatic: SGOT and SGPT < 5 x upper limit of institutional normal (ULN)

- Pulmonary: oxygen saturation ≥ 90% on room air

- Cardiac: LVEF ≥ 40% by echocardiogram, MUGA or cardiac MRI, no uncontrolled
angina, uncontrolled atrial or ventricular arrhythmias, or evidence of acute
ischemia or active conduction system abnormalities (rate controlled a-fib is not
an exclusion)

- Ability to be off prednisone and other immunosuppressive drugs for at least 3 days
prior to the NK cell infusion (excluding preparative regimen pre-meds)

- Sexually active females of childbearing potential and males with partners of child
bearing potential must agree to use appropriate birth control precautions during the
study and for 3 months after the NK cell infusion

- Voluntary written consent prior to the performance of any research related procedures

Exclusion Criteria:

- Pregnant or lactating as the treatments used in this study includes drugs that are FDA
Pregnancy Category D - Positive evidence of human fetal risk based on adverse reaction
data from investigational or marketing experience or studies in humans. Women of child
bearing potential must have a negative pregnancy test within 14 days of study
registration.

- Acute leukemias of ambiguous lineage

- AML that transformed from previously treated myelodysplastic syndromes

- Untreated CNS leukemia

- Prior hematopoietic transplant

- New or progressive pulmonary infiltrates on screening chest x-ray or chest CT scan
that has not been cleared by Pulmonary. Infiltrates attributed to infection must be
stable/improving (with associated clinical improvement) after 1 week of appropriate
therapy (4 weeks for presumed or documented fungal infections)

- Uncontrolled bacterial, fungal, or viral infections including HIV - chronic
asymptomatic viral hepatitis is allowed

- Known hypersensitivity to one or more of the study agents