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

NCT01256073 | Completed Phase 1

• 1 other identifier: IPH 2101-102
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 6

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 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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

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

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

  every 2 weeks

Secondary Outcomes (3)

• To assess the pharmacokinetics upon repeated dosing(s)of Anti-KIR(1-7F9)

  every 2 weeks

• To assess the pharmacodynamics upon repeated dosing(s) of Anti-KIR(1-7F9)

  every 2 or 4 weeks

• To assess signs of efficacy of repeated dosing(s) with Anti-KIR(1-7F9)

  to date of progression diagnosed or until death

Study Arms (1)

IPH2101

EXPERIMENTAL

Drug: IPH2101

Interventions

IPH2101 DRUG

IPH2101 fully human anti-KIR monoclonal antibody

IPH2101

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Innate Pharma: lead

Study Sites (6)

Institut Paoli-Calmettes

Marseille, Marseille Cedex 09, 13273, France

Location

Hopital Dupuytren

Limoges, 87042, France

Location

C.H.R.U. de Nantes - Hotel Dieu

Nantes, 44093, France

Location

Centre Hospitalier Lyon Sud - Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

Hopital de Purpan

Toulouse, 31059, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

IPH-2101

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Norbert Vey, MD

  Institut Paoli Calmettes Marseille France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 8, 2010
• Study Start: February 1, 2007
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

FR (6)