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Acute Myeloid LeukemiaPhase 2EFFIKIRNCT01687387

Efficacy Study of Anti-KIR Monoclonal Antibody as Maintenance Treatment in Acute Myeloid Leukemia (EFFIKIR)

A Phase 2 study testing IPH2102 at 0.1 mg/kg and IPH2102 at 1 mg/kg in people with Acute Myeloid Leukemia, run by Innate Pharma at 43 sites in France.

Completed

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

Official record
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Trial summary

Double-Blind Placebo-Controlled Randomized Phase 2 Study evaluating the efficacy of lirilumab (IPH2102/BMS-986015) as Maintenance Treatment administered in elderly patients with Acute Myeloid Leukemia (AML) in first complete remission 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?
IPH2102 at 0.1 mg/kg and IPH2102 at 1 mg/kg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
152 participants
Where
43 sitesFrance
Study dates
Oct 2012to 17 Nov 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Primary or secondary Acute Myeloid Leukemia (AML, defined according to WHO 2008 criteria), in first CR/CRi (according to the revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia J Clin Oncol. 2003 Dec 15; 21(24):4642-9 see appendix 19.3) following induction chemotherapy and who received 1 or 2 consolidation cycles. Induction chemotherapy should be performed within 6 months before randomization. Consolidation cycle is defined as any chemotherapy administered within 3 months following CR and including aracytine irrespective of the administered dose(s). A minimum of one and maximum of 2 cycles should be administered before enrollment
  • Patients not eligible for an allogeneic hematopoietic cell transplantation
  • Age 60 to 80
  • ECOG Performance status of 0 or 1
  • Clinical laboratory values at screening
  • Calculated creatinine clearance (according to MDRD) > 60 ml/min/1.73 m2
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  • Platelet > 75 x 109/l
  • Hemoglobin ≥ 10 g/dl supported or unsupported by transfusions
  • ANC > 1 x 109/l
  • Total Bilirubin levels ≤ 1.5 ULN
  • ALT and AST ≤ 3 ULN
  • Recovery from acute toxicity of previous anti-tumor therapy
  • Male patients who accept and are able to use contraception methods recognized as highly effective.
  • Signed informed consent prior to any protocol specific procedure.

Who cannot join

  • Acute Promyelocytic Leukemia with t (15; 17), or its molecular equivalents (PML-RARA)
  • Favorable risk AML corresponding defined as t(8;21) or inv (16) and t(16;16) and their molecular equivalents (AML-ETO and CBFB-MYH11)
  • Last consolidation completed more than 3 months prior to first dosing
  • Concomitant treatment by chemotherapy, immunotherapy or by systemic corticosteroids
  • Within 28 days prior to first dosing: chemotherapy or systemic corticosteroid treatment
  • History of allogeneic hematopoietic cell transplantation or solid organ transplantation
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  • History of high dose chemotherapy with autologous hematopoietic transplantation performed as treatment for AML
  • Use of any investigational agent within 2 months prior to the first dosing
  • Use of growth factors (G- or GM-CSF or EPO) within 28 days prior to first dosing
  • Any irradiation within the last 3 months except for analgesic intent
  • Intermittent or continuous renal replacement therapy
  • Abnormal cardiac status with any of the following
  • Ejection fraction (measured by ultra-sound or radionuclide imaging) <50%
  • Myocardial infarction within the previous 6 months
  • QTc ≥ 480 ms (Bazett's).
  • Current active infectious disease or positive serology for HIV, and/or HCV with detectable viremia and/ or HBV with positive Hbs Antigen and/or negative anti Hbs Antibody
  • Auto-immune disease:
  • Which currently or previously required systemic immunosuppressive or immuno-modulatory therapy (including corticosteroids administered by systemic route)
  • And/or has substantial probability to cause an irreversible injury to any tissue
  • And/or is recent or unstable or has substantial risk to progress and cause severe complications.
  • Serious concurrent uncontrolled medical disorder
  • History of another malignancy (apart from myelodysplastic syndromes, basal cell carcinoma of the skin, or in situ cervix carcinoma) except if free of disease for ≥ 3 years
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

France43 sites

  • CHU d'Amiens

    Amiens, 80054

  • CHU Angers

    Angers, 49933

  • Centre hospitalier Victor Dupouy

    Argenteuil, 95107

  • Centre hospitalier de la côte Basque

    Bayonne, 64100

  • CHU de Besançon

    Besançon, 25030

  • CHG de Béziers

    Béziers, 34500

  • CH de Blois

    Blois, 41000

  • Hôpital Avicenne

    Bobigny, 93000

  • Hôpital Morvan CHU Brest

    Brest, 29609

  • CH René Dubos

    Cergy-Pontoise, 95303

  • Hôpital Militaire Percy

    Clamart, 92141

  • CHU Estaing

    Clermont-Ferrand, 63003

  • Centre hospitalier sud francilien

    Corbeil-Essonnes, 91100

  • Hôpital Henri Mondor

    Créteil, 94010

  • CHU de Grenoble

    Grenoble, 38043

  • Centre Hospitalier de Versailles

    Le Chesnay, 78157

  • Hôpital Claude Huriez

    Lille, 59037

  • CHU de Limoges

    Limoges, 87042

  • Institut Paoli - Calmettes

    Marseille, 13273

  • CH de Meaux

    Meaux, 77104

  • CHU Saint Eloi

    Montpellier, 34295

  • Centre Hospitalier de Mulhouse

    Mulhouse, 68100

  • CHU de Nantes

    Nantes, 44000

  • Centre Antoine Lacassagne

    Nice, 06189

  • CHU Caremeau

    Nîmes, 30029

  • CHR d'Orléans

    Orléans, 45067

  • Hôpital Saint-Louis

    Paris, 75010

  • Hôpital Saint-Antoine

    Paris, 75012

  • Hôpital Necker

    Paris, 75743

  • CH Saint-Jean

    Perpignan, 66000

  • CHU de Bordeaux - Hôpital Haut-Lévêque

    Pessac, 33604

  • Centre hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • CHU de Poitiers

    Poitiers, 86021

  • CHR d'Annecy

    Pringy, 74374

  • CHU de Reims

    Reims, 51092

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre René Huguenin

    Saint-Cloud, 92210

  • CH Saint-Quentin

    Saint-Quentin, 02321

  • Hôpital Haute Pierre et Hôpital Civil

    Strasbourg, 67098

  • CHU Purpan

    Toulouse, 31059

  • CH Valenciennes

    Valenciennes, 59322

  • CHU de Nancy Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: Double-Blind Placebo-Controlled Randomized Phase 2 Study of IPH2102 as Maintenance Treatment in Elderly Patients With Acute Myeloid Leukemia (AML) in First Complete Remission

Double-Blind Placebo-Controlled Randomized Phase 2 Study evaluating the efficacy of lirilumab (IPH2102/BMS-986015) as Maintenance Treatment administered in elderly patients with Acute Myeloid Leukemia (AML) in first complete remission

Being tested
IPH2102 at 0.1 mg/kg, IPH2102 at 1 mg/kg, Placebo (normal saline solution)
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.

  • IPH2102 at 0.1 mg/kgDrug

    Also called lirilumab/BMS986015

    every 3 months

  • IPH2102 at 1 mg/kgDrug

    Also called lirilumab/BMS986015

    every 4 weeks

  • Placebo (normal saline solution)Drug

    Also called normal saline solution

    every 4 weeks

Study groups in NCT01687387
Study groupRoleWhat they receive
IPH2102 at 1 mg/kgExperimentallirilumab (IPH2102/BMS986015) at 1 mg/kg
Receives: Drug: IPH2102 at 1 mg/kg
IPH2102 at 0.1 mg/kgExperimentallirilumab (IPH2102/BMS986015) at 0.1 mg/kg
Receives: Drug: IPH2102 at 0.1 mg/kg; Drug: Placebo (normal saline solution)
Placebo (Normal saline solution)Placebo comparatorNormal saline solution
Receives: Drug: Placebo (normal saline solution)

What is being measured

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

  1. Leukemia-Free Survival

    Measured: from date of randomization until the date of first documented relapse, assessed up to 48 months

Secondary outcomes (1)

  1. Number of Participants With Adverse Events

    Number of Participants with Adverse Events based on full physical examination each treatment visit and collection of AEs

    Measured: from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit, up to 24 months

Timeline

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

  1. First posted18 Sep 2012 (estimated)
  2. Study startOct 2012
  3. Primary completion17 Nov 2016
  4. Study completion17 Nov 2016

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01687387
Sponsor's protocol ID
IPH2102-201
Acronym
EFFIKIR
Status last verified
Sep 2018
First submitted
11 Sep 2012
Last updated
8 Feb 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IPH2102 at 0.1 mg/kg and IPH2102 at 1 mg/kg in people with Acute Myeloid Leukemia, run by Innate Pharma at 43 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 14 inclusion and 23 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 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Leukemia-Free Survival (time frame: from date of randomization until the date of first documented relapse, assessed up to 48 months). 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 NCT01687387.

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 8 Feb 2019.

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