A Safety and Tolerability Extension Trial Assessing Repeated Dosing of Anti-KIR (1-7F9) Human Monoclonal Antibody in Patients With Acute Myeloid Leukaemia

Inclusion criteria

• Informed consent obtained before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
• Acute myeloid leukaemia (AML) according to WHO Criteria
• Morphological complete remission (CR) defined according to NCI criteria, or CRi with incomplete platelet count recovery only after 1 or 2 cycles of induction chemotherapy, and at least 1, and maximally 6 cycles of consolidation chemotherapy:

• Absolute neutrophile count > 1x 109/L
• Platelets > 80x109/L
• Independency of blood transfusions
• Less than 5% blasts in bone-marrow
• No Auer rods
• No symptoms of disease
• Life expectancy > 4 months as judged by the Investigator
• The patient is > or = 60 years of age but < or = 80 years of age
• The patient has completed participation in the IPH2101-101(previously NN1975-1733)trial with an acceptable safety profile, as judged by the Investigator or is screened for the additional cohort
• Time since last dose of chemotherapy at least 30 days and no more than 60 days if the patient did not participate in IPH2101-101 trial before
• Recovery from acute toxicities of all previous anti-leukaemic therapies
• KIR-expression on patient NK-cells (ability to bind Anti-KIR(1-7F9)) if the patient did not participate in IPH2101-101 trial before
• ECOG performance status 0, 1 or 2
• No major organ dysfunction as judged by the Investigator
• The patients must have the following clinical laboratory values:

• Serum creatinine < or = 2 md/dL
• Total bilirubin < or = 1.5 x the upper limit of normal
• Asparatate aminotransferase (AST) < 3x the upper limit of normal

Exclusion criteria

• Known or suspected allergy to trial product or related products
• Previous participation in this trial
• AML classified as FAB M3 (APL, acute promyelocytic leukaemia) or with good prognosis AML i.e. t(8;21)(q22;q22) or inv(16)(p13q22) or t(16;16)(p13;q22) or their molecular equivalents
• Eligibility for allogeneic haematopoietic transplantation
• The patient is currently receiving, or has within the last 4 weeks received other investigational anti-leukemic treatment such as cytokine treatment, except Anti-KIR(1-7F9)
• The patient has received G-CSF treatment within the last 30 days prior to screening
• Systemic steroid treatment within the last 4 weeks prior to screening
• Patient has active autoimmune disease
• Diagnosis of monoclonal gammopathy
• Patient has active infectious disease
• Previous leukaemic CNS involvement
• Cardiac failure (New York Heart Association [NYHA] grade III-IV)
• Left ventricular ejection fraction (LVEF) less than 45 % of normal evaluated by ultrasound or isotopic evaluation
• Severe neurological/psychiatric disorder
• HIV or chronic hepatitis infection
• Clinical evidence of an active second malignancy
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
• Any new medical condition that in the opinion of the Investigator disqualifies the patient for inclusion