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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Innate Pharma
ClinicalTrials.gov Identifier:
NCT01256073
First received: December 7, 2010
Last updated: February 27, 2014
Last verified: February 2014

December 7, 2010
February 27, 2014
February 2007
July 2013   (final data collection date for primary outcome measure)
To assess safety and tolerability of repeating dosings of Anti-KIR(1-7F9) [ Time Frame: every 2 weeks ] [ Designated as safety issue: Yes ]
using the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
Same as current
Complete list of historical versions of study NCT01256073 on ClinicalTrials.gov Archive Site
  • To assess the pharmacokinetics upon repeated dosing(s)of Anti-KIR(1-7F9) [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]
  • To assess the pharmacodynamics upon repeated dosing(s) of Anti-KIR(1-7F9) [ Time Frame: every 2 or 4 weeks ] [ Designated as safety issue: No ]
    • Degree of KIR-occupancy on patient NK-cells
    • Plasma inflammatory cytokines (IFN-γ, TNF-α, IL-1, IL-6)
    • Immunophenotyping (NK-, B- and T-lymphocyte counts and activation status)
    • NK-cell surface markers (activation markers and inhibitory receptors)
    • Functional assay of NK-cell activity only for patient from additional cohort
  • To assess signs of efficacy of repeated dosing(s) with Anti-KIR(1-7F9) [ Time Frame: to date of progression diagnosed or until death ] [ Designated as safety issue: No ]
    • Reduction in minimal residual disease measured by WT-1 expression in blood and bone marrow
    • Progression-free survival (measured as calendar days from the first dosing of Anti-KIR(1-7F9) (in the IPH2101-101 trial) to date of progression diagnosed or until death by any cause
    • Overall survival measured as calendar days from the first dosing of Anti-KIR (1-7F9) to date of death
Same as current
Not Provided
Not Provided
 
A Safety and Tolerability Extension Trial Assessing Repeated Dosing of Anti-KIR (1-7F9) Human Monoclonal Antibody in Patients With Acute Myeloid Leukaemia
An Open-label, Safety and Tolerability Extension Trial Assessing Repeated Dosing of Anti-KIR (1-7F9) Human Monoclonal Antibody in Patients With Acute Myeloid Leukaemia

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 dose level. The trial is conducted in elderly Acute Myeloid Leukemia (AML) patients over the age of 60 years, in complete remission, and who are not eligible for allogeneic stem-cell transplantation. The dose given to the individual patient will be the same as the patient received in the single dose trial IPH2101-101 and 1 mg/kg or 2 mg/kg for the 12 patients in an additional cohort.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myeloid Leukemia
Drug: IPH2101
IPH2101 fully human anti-KIR monoclonal antibody
Experimental: IPH2101
Intervention: Drug: IPH2101
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
September 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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)
  2. Acute myeloid leukaemia (AML) according to WHO Criteria
  3. 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
  4. Life expectancy > 4 months as judged by the Investigator
  5. The patient is > or = 60 years of age but < or = 80 years of age
  6. 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
  7. 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
  8. Recovery from acute toxicities of all previous anti-leukaemic therapies
  9. KIR-expression on patient NK-cells (ability to bind Anti-KIR(1-7F9)) if the patient did not participate in IPH2101-101 trial before
  10. ECOG performance status 0, 1 or 2
  11. No major organ dysfunction as judged by the Investigator
  12. 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:

  1. Known or suspected allergy to trial product or related products
  2. Previous participation in this trial
  3. 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
  4. Eligibility for allogeneic haematopoietic transplantation
  5. 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)
  6. The patient has received G-CSF treatment within the last 30 days prior to screening
  7. Systemic steroid treatment within the last 4 weeks prior to screening
  8. Patient has active autoimmune disease
  9. Diagnosis of monoclonal gammopathy
  10. Patient has active infectious disease
  11. Previous leukaemic CNS involvement
  12. Cardiac failure (New York Heart Association [NYHA] grade III-IV)
  13. Left ventricular ejection fraction (LVEF) less than 45 % of normal evaluated by ultrasound or isotopic evaluation
  14. Severe neurological/psychiatric disorder
  15. HIV or chronic hepatitis infection
  16. Clinical evidence of an active second malignancy
  17. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
  18. Any new medical condition that in the opinion of the Investigator disqualifies the patient for inclusion
Both
60 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01256073
IPH 2101-102
No
Innate Pharma
Innate Pharma
Not Provided
Principal Investigator: Norbert Vey, MD Institut Paoli Calmettes Marseille France
Innate Pharma
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP