Clinical Drug Experience Knowledgebase

Criteria

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