CNDO-109-AANK for AML in First Complete Remission (CR1)

Inclusion Criteria

• •1. The patient has pathologically documented AML and is in CR1 at the time of the screening visit
• •2. The patient achieved CR1 within 10 weeks of the screening visit; the patient may have received post-remission consolidation therapy (except for transplant) prior to the screening visit
• •3. A bone marrow aspiration performed within 21 days prior to the start of pre-infusion preparative therapy confirms the patient is in CR1
• •4. The patient has either refused or is not considered an appropriate immediate candidate for transplantation and is considered to be at high risk for recurrence by having at least one of the following prognostic factors:
• •* High risk cytogenetics (-5, -7, del(5q), abnormal 3q, 11q23 translocations, complex cytogenetics) or if cytogenetics are normal the presence of a FLT3 mutation without a NPM1 mutation
• •* Age \> 60 years
• •* Antecedent hematological disorder (AHD)
• •* AML that is considered to be therapy-related
• •* FAB subtype M0 (minimally differentiated acute myeloblastic leukemia), M6 (acute erythroid leukemias, including erythroleukemia (M6a) and pure erythroid leukemia (M6b)), or M7 (acute megakaryoblastic leukemia)
• •5. The patient is male or female, age 18 years or older
• •6. The patient has an ECOG performance status of 0, 1, or 2
• •7. The patient has an available NK cell donor who is a HLA haploidentical first-degree (parent, child, or sibling) or second-degree (child of a sibling) relative; minimum testing will be for HLA-A, HLA-B, and HLA-DR with donors matched for 3/6, 4/6 or 5/6 antigens
• •8. The patient has an absence of coexisting medical problems that would significantly increase the risk of the chemotherapy procedure (e.g. poor left ventricular ejection fraction \[LVEF\<40%\])
• •9. The patient has recovered from reversible toxicity from prior therapy. Permanent and stable side effects or changes are acceptable if ≤ Grade 1 (CTCAE, v4.03)
• •10. The patient has serum creatinine \<2×ULN and not rising for at least 2-4 weeks before chemotherapy. If elevated, the 24-hour creatinine clearance must be \>50 mL/min
• •11. The patient has serum total bilirubin \< 2 g/dL (unless the patient has a diagnosis of Gilbert's disease), SGOT (ALT) \<3.5×ULN, and SGPT (AST) \<3.5×ULN
• •12. The patient has an absolute neutrophil count (ANC) ≥1000/µL, platelets ≥100,000/µL and is not transfusion dependent for platelets and/or red cells
• •13. The patient has LVEF ≥40% by ECHO or MUGA scan and no clinically significant abnormalities in 12-lead ECG
• •14. The patient has a PT (or INR) and PTT up to 1.25×ULN
• •15. The patient must not be dependent on supplemental oxygen
• •16. The patient is using an effective contraceptive (per the institutional standard), if procreative potential exists
• •17. The patient must be willing and able to comply with all study protocol requirements. The patient or a legally authorized representative must fully understand all elements of the informed consent and have signed the informed consent according to institutional and federal regulatory requirements
• •18. The patient has not received an investigational chemotherapy within the last 28 days prior to the screening visit and has never received investigational immunotherapy. In addition, the patient must not receive treatment for AML (including treatment with IL-2 or IFNγ) in the interval of time between the screening visit and initiation of pre-infusion preparative therapy