Cytokine-Induced Killer Cells after Donor Stem Cell Transplant in Treating Patients with Refractory or Relapsed Acute Myeloid Leukemia

Inclusion Criteria

• Refractory AML without complete remission (CR) after 2 or more cycles of induction therapy (primary induction failure), or AML relapsed after obtaining a CR and failed one or more cycles of re-induction therapy; standard dose 10-day decitabine (20 mg/m^2 daily IV x 10 days) or 7-day azacitidine (75-100 mg/m^2 daily SC/IV x 7 days) will be considered as one cycle of induction therapy
• At least 18 years of age
• Available human leukocyte antigen (HLA)-haploidentical donor that meets the criteria
• Patients with known central nervous system (CNS) involvement with AML are eligible provided that they have been treated and cerebrospinal fluid (CSF) is clear for at least 2 weeks prior to enrollment into the study; CNS therapy (chemotherapy or radiation) should continue as medically indicated during the study treatment
• Karnofsky performance status > 60%
• Total bilirubin < 2 mg/dl
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) < 3.0 x institutional upper limit of normal (IULN)
• Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m^2 by Cockcroft-Gault formula
• Oxygen saturation >= 90% on room air and adjusted diffusing capacity of the lungs for carbon monoxide (DLCO) of at least 40%
• Ejection fraction >= 40%
• Able to be off of corticosteroids (10 mg or less of prednisone or equivalent doses of other systemic steroids are allowed) and any other immune suppressive medications beginning on day -3
• Women of childbearing potential must have a negative pregnancy test within 28 days prior to study registration; female and male patients (along with their female partners) must agree to use two forms of acceptable contraception, including one barrier method, during participation in the study including throughout the initial evaluation period (100 days after CIML NK cell infusion)
• Ability to understand and willingness to sign an Institutional Review Board (IRB) approved written informed consent document (or that of legally authorized representative, if applicable)
• DONOR: Related donor (parents, sibling, offspring, or offspring of sibling)
• DONOR: At least 18 years of age
• DONOR: HLA-haploidentical donor/recipient match by molecular typing at the HLA-A, HLA-B and HLA-DRB1 loci
• DONOR: In general good health, and medically able to tolerate leukapheresis required for harvesting the NK cells for this study
• DONOR: Ability to understand and willingness to sign an IRB approved written informed consent document

Exclusion Criteria

• Relapsed after allogeneic transplantation
• Circulating blast count > 30,000/uL by morphology or flow cytometry (cyto-reductive therapies including leukapheresis or hydroxyurea are allowed)
• Uncontrolled bacterial or viral infections, or known human immunodeficiency virus (HIV), hepatitis B or C infection
• Presence of donor specific antibodies (DSA) with mean fluorescence intensity (MFI) of >= 5000 as assessed by the single antigen bead assay, < 6 weeks prior to starting transplant conditioning
• Uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiogram (EKG) suggestive of acute ischemia or active conduction system abnormalities
• New or progressive pulmonary infiltrates; progressive pulmonary infiltrate is defined as an increase of 20% or greater from prior radiologic exam; radiologic assessment methods may be computed tomography (CT) or posterioranterior (PA)/lateral (L) x-ray imaging; infiltrates attributed to infection must be stable or improving after 1 week of appropriate therapy, or 4 weeks for presumed or proven fungal infections to be eligible
• Known hypersensitivity to one or more of the study agents
• Received any investigational drugs within the 14 days prior to the first day of transplant conditioning
• Pregnant and/or breastfeeding
• DONOR: Positive for hepatitis, human T-lymphotropic virus (HTLV), or HIV infection
• DONOR: Pregnant and/or breastfeeding