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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Innate Pharma
ClinicalTrials.gov Identifier:
NCT01687387
First received: September 11, 2012
Last updated: December 1, 2014
Last verified: December 2014
  Purpose

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


Condition Intervention Phase
Acute Myeloid Leukemia
Drug: IPH2102 at 0.1 mg/kg
Drug: IPH2102 at 1 mg/kg
Drug: Placebo (normal saline solution)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Innate Pharma:

Primary Outcome Measures:
  • Leukemia-Free Survival [ Time Frame: from date of randomization until the date of first documented relapse, assessed up to 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: 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 ] [ Designated as safety issue: Yes ]
    based on full physical examination each treatment visit and collection of AEs


Estimated Enrollment: 150
Study Start Date: October 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPH2102 at 1 mg/kg
lirilumab (IPH2102/BMS986015) at 1 mg/kg
Drug: IPH2102 at 1 mg/kg
every 4 weeks
Other Name: lirilumab/BMS986015
Experimental: IPH2102 at 0.1 mg/kg
lirilumab (IPH2102/BMS986015) at 0.1 mg/kg
Drug: IPH2102 at 0.1 mg/kg
every 3 months
Other Name: lirilumab/BMS986015
Drug: Placebo (normal saline solution)
every 4 weeks
Other Name: normal saline solution
Placebo Comparator: Placebo (Normal saline solution)
Normal saline solution
Drug: Placebo (normal saline solution)
every 4 weeks
Other Name: normal saline solution

  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Patients not eligible for an allogeneic hematopoietic cell transplantation
  3. Age 60 to 80
  4. ECOG Performance status of 0 or 1
  5. Clinical laboratory values at screening

    • Calculated creatinine clearance (according to MDRD) > 60 ml/min/1.73 m2
    • 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
  6. Recovery from acute toxicity of previous anti-tumor therapy
  7. Male patients who accept and are able to use contraception methods recognized as highly effective.
  8. Signed informed consent prior to any protocol specific procedure.

Exclusion Criteria:

  1. Acute Promyelocytic Leukemia with t (15; 17), or its molecular equivalents (PML-RARA)
  2. 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)
  3. Last consolidation completed more than 3 months prior to first dosing
  4. Concomitant treatment by chemotherapy, immunotherapy or by systemic corticosteroids
  5. Within 28 days prior to first dosing: chemotherapy or systemic corticosteroid treatment
  6. History of allogeneic hematopoietic cell transplantation or solid organ transplantation
  7. History of high dose chemotherapy with autologous hematopoietic transplantation performed as treatment for AML
  8. Use of any investigational agent within 2 months prior to the first dosing
  9. Use of growth factors (G- or GM-CSF or EPO) within 28 days prior to first dosing
  10. Any irradiation within the last 3 months except for analgesic intent
  11. Intermittent or continuous renal replacement therapy
  12. 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).
  13. 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
  14. 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.
  15. Serious concurrent uncontrolled medical disorder
  16. 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
  17. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687387

Locations
France
CHU d'Amiens
Amiens, France, 80054
CHU Angers
Angers, France, 49933
Centre hospitalier Victor Dupouy
Argenteuil, France, 95107
Centre hospitalier de la côte Basque
Bayonne, France, 64100
CHU de Besançon
Besançon, France, 25030
CH de Blois
Blois, France, 41000
Hôpital Avicenne
Bobigny, France, 93000
Hôpital Morvan CHU Brest
Brest, France, 29609
CHG de Béziers
Béziers, France, 34500
CH René Dubos
Cergy Pontoise, France, 95303
Hôpital Militaire Percy
Clamart, France, 92141
CHU Estaing
Clermont-Ferrand, France, 63003
Centre hospitalier sud francilien
Corbeil Essonnes, France, 91100
Hôpital Henri Mondor
Créteil, France, 94010
CHU de Grenoble
Grenoble, France, 38043
Centre Hospitalier de Versailles
Le Chesnay Cedex, France, 78157
Hôpital Claude Huriez
Lille, France, 59037
CHU de Limoges
Limoges, France, 87042
Institut Paoli - Calmettes
Marseille Cedex 09, France, 13273
CH de Meaux
Meaux, France, 77104
CHU Saint Eloi
Montpellier Cedex 5, France, 34295
Centre Hospitalier de Mulhouse
Mulhouse, France, 68100
CHU de Nantes
Nantes, France, 44000
Centre Antoine Lacassagne
Nice, France, 06189
CHU Caremeau
Nîmes, France, 30029
CHR d'Orléans
Orléans, France, 45067
Hôpital Saint-Antoine
Paris, France, 75012
Hôpital Saint-Louis
Paris, France, 75010
Hôpital Necker
Paris Cedex 15, France, 75743
CH Saint-Jean
Perpignan, France, 66000
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac, France, 33604
Centre hospitalier Lyon Sud
Pierre Bénite, France, 69495
CHU de Poitiers
Poitiers, France, 86021
CHR d'Annecy
Pringy, France, 74374
CHU de Reims
Reims, France, 51092
Centre Henri Becquerel
Rouen, France, 76038
Centre René Huguenin
Saint-Cloud, France, 92210
CH Saint-Quentin
Saint-Quentin, France, 02321
Hôpital Haute Pierre et Hôpital Civil
Strasbourg, France, 67098
CHU Purpan
Toulouse, France, 31059
CH Valenciennes
Valenciennes, France, 59322
CHU de Nancy Hôpitaux de Brabois
Vandoeuvre Les Nancy, France, 54511
Institut Gustave Roussy
Villejuif, France, 94805
Sponsors and Collaborators
Innate Pharma
Investigators
Principal Investigator: Norbert Vey, MD Institut Paoli Calmettes Marseille France
Study Chair: Hervé Dombret, MD ALFA cooperative Group
Study Chair: Norbert Ifrah, MD GOELAMS Cooperative Group
  More Information

No publications provided

Responsible Party: Innate Pharma
ClinicalTrials.gov Identifier: NCT01687387     History of Changes
Other Study ID Numbers: IPH2102-201
Study First Received: September 11, 2012
Last Updated: December 1, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 29, 2015