AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 1NCT01256073

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

A Phase 1 study testing IPH2101 in people with Acute Myeloid Leukemia, run by Innate Pharma at 6 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
IPH2101
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
6 sitesFrance
Study dates
Feb 2007to Sep 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 21Show fewer
  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Hopital Dupuytren

    Limoges, 87042

  • Institut Paoli-Calmettes

    Marseille, Marseille Cedex 09, 13273

  • C.H.R.U. de Nantes - Hotel Dieu

    Nantes, 44093

  • Centre Hospitalier Lyon Sud - Hospices Civils de Lyon

    Pierre-Bénite, 69495

  • Hopital de Purpan

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: 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.

Being tested
IPH2101
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IPH2101Drug

    IPH2101 fully human anti-KIR monoclonal antibody

Study groups in NCT01256073
Study groupRoleWhat they receive
IPH2101ExperimentalNot described
Receives: Drug: IPH2101

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: every 2 weeks

Secondary outcomes (3)

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

    Measured: every 2 weeks

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

    • 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

    Measured: every 2 or 4 weeks

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

    • 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

    Measured: to date of progression diagnosed or until death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2010 (estimated)
  2. Study startFeb 2007
  3. Primary completionJul 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01256073
Sponsor's protocol ID
IPH 2101-102
Status last verified
Feb 2014
First submitted
7 Dec 2010
Last updated
28 Feb 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IPH2101 in people with Acute Myeloid Leukemia, run by Innate Pharma at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess safety and tolerability of repeating dosings of Anti-KIR(1-7F9) (time frame: every 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01256073.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014; AzTrials last refreshed its copy on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in