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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


Phase 1
60 Years
80 Years
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess safety and tolerability of repeating dosings of Anti-KIR(1-7F9)

Outcome Description:

using the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)

Outcome Time Frame:

every 2 weeks

Safety Issue:

Yes

Principal Investigator

Norbert Vey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Paoli Calmettes Marseille France

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IPH 2101-102

NCT ID:

NCT01256073

Start Date:

February 2007

Completion Date:

September 2013

Related Keywords:

  • Acute Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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