Status:
COMPLETED
A Safety and Tolerability Extension Trial Assessing Repeated Dosing of Anti-KIR (1-7F9) Human Monoclonal Antibody in Patients With Acute Myeloid Leukaemia
Lead Sponsor:
Innate Pharma
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60-80 years
Phase:
PHASE1
Brief Summary
The trial is a multi-centre, open-label, safety and tolerability extension trial to the IPH2101-101 (previously NN1975-1733) first human dose trial completed with a larger subject pool at an optimal d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01256073
Start Date
February 1 2007
End Date
September 1 2013
Last Update
February 28 2014
Active Locations (6)
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1
Institut Paoli-Calmettes
Marseille, Marseille Cedex 09, France, 13273
2
Hopital Dupuytren
Limoges, France, 87042
3
C.H.R.U. de Nantes - Hotel Dieu
Nantes, France, 44093
4
Centre Hospitalier Lyon Sud - Hospices Civils de Lyon
Pierre-Bénite, France, 69495