MT2014-25: Haplo NK With SQ IL-15 in Adult Relapsed or Refractory AML Patients

Inclusion Criteria (Recipient):

- Meets ONE of the following disease criteria:

1. Primary AML induction failure: no CR after 2 or more induction attempts

2. Relapsed AML or Secondary AML (from MDS or treatment related): not in CR after 1
or more cycles of standard re-induction therapy

3. AML relapsed > 2 months after transplant: No re-induction required, and no more
than 1 re-induction cycle is allowed.

4. Relapsed AML for patients > 60 years of age the 1 cycle of standard chemotherapy
is not required if either of the following criteria is met:

- Relapse within 6 months of last chemotherapy

- BM blast count < 30% within 10 days of starting protocol therapy

- Available related HLA-haploidentical donor (aged 14 to 75 years) by at least Class I
serologic typing at the A&B locus

- Karnofsky Performance Status ≥ 60%

- Patients must have adequate organ within 14 days (28 days for pulmonary and cardiac)
of study registration

- Able to be off prednisone or other immunosuppressive medications for at least 3 days
prior to NK cell infusion (excluding preparative regimen pre-medications).

- Agrees to use contraception prior to study entry and for the duration of study
participation.

Exclusion Criteria (Recipient):

- Bi-phenotypic acute leukemia.

- Transplant < 60 days prior to study enrollment.

- Active autoimmune disease.

- History of severe asthma

- Uncontrolled intercurrent illness

- New or progressive pulmonary infiltrates on screening chest x-ray or chest CT scan
that has not been evaluated with bronchoscopy

- Pleural effusion large enough to be detectable on chest x-ray.

- Pregnant women

- History of HIV, active or chronic hepatitis B, hepatitis C or HTLV-I infection

- Known hypersensitivity to any of the study agents used

- Received investigational drugs within the 14 days of study registration.

- Known active CNS involvement.

Criteria For Initial Donor Selection:

- Related donors (sibling, parent, offspring, parent or offspring of an HLA identical
sibling).

- 14-75 years of age.

- At least 40 kilogram body weight.

- In general good health as determined by the evaluating medical provider.

- HLA-haploidentical donor/recipient match by at least Class I serologic typing at the
A&B locus.

- Not pregnant.

- Able and willing to undergo apheresis.