Efficacy Study of Anti-KIR Monoclonal Antibody as Maintenance Treatment in Acute Myeloid Leukemia (EFFIKIR)

Inclusion criteria

• Primary or secondary Acute Myeloid Leukemia (AML, defined according to WHO 2008 criteria), in first CR/CRi (according to the revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia J Clin Oncol. 2003 Dec 15; 21(24):4642-9 see appendix 19.3) following induction chemotherapy and who received 1 or 2 consolidation cycles. Induction chemotherapy should be performed within 6 months before randomization. Consolidation cycle is defined as any chemotherapy administered within 3 months following CR and including aracytine irrespective of the administered dose(s). A minimum of one and maximum of 2 cycles should be administered before enrollment
• Patients not eligible for an allogeneic hematopoietic cell transplantation
• Age 60 to 80
• ECOG Performance status of 0 or 1
• Clinical laboratory values at screening

• Calculated creatinine clearance (according to MDRD) > 60 ml/min/1.73 m2
• Platelet > 75 x 109/l
• Hemoglobin ≥ 10 g/dl supported or unsupported by transfusions
• ANC > 1 x 109/l
• Total Bilirubin levels ≤ 1.5 ULN
• ALT and AST ≤ 3 ULN
• Recovery from acute toxicity of previous anti-tumor therapy
• Male patients who accept and are able to use contraception methods recognized as highly effective.
• Signed informed consent prior to any protocol specific procedure.

Exclusion criteria

• Acute Promyelocytic Leukemia with t (15; 17), or its molecular equivalents (PML-RARA)
• Favorable risk AML corresponding defined as t(8;21) or inv (16) and t(16;16) and their molecular equivalents (AML-ETO and CBFB-MYH11)
• Last consolidation completed more than 3 months prior to first dosing
• Concomitant treatment by chemotherapy, immunotherapy or by systemic corticosteroids
• Within 28 days prior to first dosing: chemotherapy or systemic corticosteroid treatment
• History of allogeneic hematopoietic cell transplantation or solid organ transplantation
• History of high dose chemotherapy with autologous hematopoietic transplantation performed as treatment for AML
• Use of any investigational agent within 2 months prior to the first dosing
• Use of growth factors (G- or GM-CSF or EPO) within 28 days prior to first dosing
• Any irradiation within the last 3 months except for analgesic intent
• Intermittent or continuous renal replacement therapy
• Abnormal cardiac status with any of the following

• Ejection fraction (measured by ultra-sound or radionuclide imaging) <50%
• Myocardial infarction within the previous 6 months
• QTc ≥ 480 ms (Bazett's).
• Current active infectious disease or positive serology for HIV, and/or HCV with detectable viremia and/ or HBV with positive Hbs Antigen and/or negative anti Hbs Antibody
• Auto-immune disease:

• Which currently or previously required systemic immunosuppressive or immuno-modulatory therapy (including corticosteroids administered by systemic route)
• And/or has substantial probability to cause an irreversible injury to any tissue
• And/or is recent or unstable or has substantial risk to progress and cause severe complications.
• Serious concurrent uncontrolled medical disorder
• History of another malignancy (apart from myelodysplastic syndromes, basal cell carcinoma of the skin, or in situ cervix carcinoma) except if free of disease for ≥ 3 years
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.