NK Cell Based Non-Myeloablative Transplantation in Acute Myeloid Diseases

Inclusion Criteria

• •Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
• •RAEB-1 or RAEB-2 fitting within one of the following disease groups:
• •Primary induction failure (PIF): Patients who have not achieved a complete remission (CR) after two induction cycles of cytotoxic therapy (i.e. 7+ 3, MEC, FLAG, etc.) and having ≤ 10,000 absolute circulating blasts measured at least 21 days from prior therapy. Hydroxyurea may be used to control blasts count. Demethylating agents do not count as induction therapy; however early re-induction therapy based on residual disease on a day 14 BM will count as a 2nd cycle
• •Relapsed Disease with low disease burden (AML or MDS with ≤ 10,000 absolute circulating blasts. No re-induction attempts are required, but a maximum of 2 reinduction attempts are allowed to be eligible.
• •CR3 or greater: This will include CRp defined as CR without platelet recovery to 100,000/mcL.
• •CR1 or CR2 with high risk features: Includes therapy induced, prior MDS or MPD, high risk cytogenetic or molecular phenotype with no available donor (sibling or unrelated adult)
• •Patients with known prior central nervous system (CNS) involvement are eligible provided that it has been treated and CSF is clear for at least 2 weeks prior to enrollment. CNS therapy (chemotherapy or radiation) should continue as medically indicated during the study treatment.
• •Available related HLA-haploidentical adult donor by at least Class I serologic typing at the A\&B locus
• •Karnofsky score \> 50%
• •Adequate organ function within 28 days of study registration defined as:
• •* Hepatic: AST ≤ 3 x upper limit of institutional normal, total bilirubin ≤ 2.0 mg/dl
• •* Renal: estimated glomerular filtration rate (GFR) ≥ 50 mL/min/1.73m\^2
• •* Pulmonary: Oxygen saturation ≥ 90% on room air and DLCOcor ≥ 40%
• •* Cardiac: Ejection Fraction ≥ 35% and no uncontrolled angina, severe uncontrolled ventricular or arterial arrhythmias, or any evidence of acute ischemia or active conduction system abnormalities (rate controlled atrial fibrillation is not an exclusion)
• •Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to NK cell infusion (except for those prescribed as part of the study)
• •Women of child bearing potential must have a negative pregnancy test within 28 days prior to study registration and agree to use adequate birth control during study treatment
• •Voluntary written consent