Donor-Derived Ex-Vivo Expanded Natural Killer Cell Infusions in Children and Young Adults With High Risk Acute Myeloid Leukemia Receiving Myeloablative HLA-Haploidentical Hematopoietic Cell Transplant

Inclusion Criteria:

Age ≤ 25 years at time of enrollment
High-risk AML, as defined by one of the following:
AML in CR1 (defined as <5% blasts in BM by morphology and flow cytometry) having at least one of these high-risk features:
Mutations associated with high risk disease (Appendix A). Other high-risk features not explicitly stated in Appendix A can be considered after discussion/approval with the protocol chair/team
MRD-positive at the end of Induction I chemotherapy (defined as flow cytometry ≥ 0.1% blasts)
AML in ≥CR2 (defined by <5% blasts in BM by morphology and flow cytometry)
Recovery from prior cycle of chemotherapy as defined by an absolute neutrophil count ≥ 500/mm3
AML secondary to select germline marrow failure disorders (with exception of Fanconi Anemia) may be eligible but require approval from Protocol Chairs prior to enrollment.
Performance status ≥70% (Lansky for <16 years; Karnofsky for ≥16 years)
Adequate major organ system function as demonstrated by:
Renal: Creatinine clearance (CrCl) ≥60 mL/min/1.73m2 by Cockcroft-Gault formula, Schwartz formula, or nuclear GFR study (Table 3)
Hepatic: Total bilirubin <2 mg/dL (unless due to Gilbert syndrome) and ALT and AST < 5x ULN
Cardiac: LVEF at rest ≥50% or SF ≥27% (by MUGA or ECHO)
Pulmonary: DLCO, FEV1, and FVC ≥ 50% of predicted corrected for hemoglobin. For patients <7 years of age or those unable to perform PFTs: O2 Sat >92% on room air by pulse oximetry and on no supplemental O2 at rest
The patient, patient's parent, guardian, or legal representative can provide written informed consent

Exclusion Criteria:

Active extramedullary disease
Unresolved/ongoing and serious viral, bacterial, or fungal infection despite appropriate treatment
Positive pregnancy test in a female of child-bearing potential (FCBP)
Inability to comply with medical therapy or follow-up
Prior allogeneic transplant
Patients with Fanconi Anemia and Down syndrome