This research study is studying cytokine induced memory-like natural killer (CIML NK) cells combined with IL-2 in adult patients (18 years of age or older) with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Myeloproliferative Neoplasms (MPN) who relapse after haploidentical hematopoietic cell transplantation (haplo-HCT) or HLA matched stem cells. This study will also study CIML NK cell infusion combined with IL-2 in pediatric patients (12 years of age or older) with AML, MDS, JMML who relapse after stem cell transplantation using HLA-matched related donor or related donor haploidentical stem cells.
Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then <3 x ULN)
AST(SGOT)/ALT(SGPT): ≤3 x institutional ULN
Serum creatinine ≤2.0mg/dL
O2 saturation: ≥90% on room air
None
Single group
CIML NK
Biological/VaccineCIML NK cells have enhanced ability to recognize and kill leukemia targets
Fludarabine
DrugFludarabine is a chemotherapy agent
Cyclophosphamide
DrugCyclophosphamide (CP), also known as cytophosphane among other names, is a chemotherapy agent
Safety
To determine the maximum tolerated dose (MTD) of CIML NK cell infusion followed by low-dose IL-2
ORR (Objective Response Rate)
To determine complete remission (CR/CRi) rate after CIML NK cell infusion plus IL-2
LFS and OS
To determine the rate of leukemia-free survival (LFS) and overall survival (OS) at day 100 and at 1 year post cell CIML NK cell infusion plus IL-2
Acute GVHD (Incidence, Severity)
To determine the incidence and severity of acute GVHD rates after CIML NK cell infusion plus IL-2
Chronic GVHD (Incidence, Severity)
To determine the incidence and severity of chronic GVHD rates after CIML NK cell infusion plus IL-2
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Dana-Farber Cancer Institute
Lead sponsor
The Leukemia and Lymphoma Society
Collaborator
