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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Innate Pharma
Sponsor:
Information provided by (Responsible Party):
Innate Pharma
ClinicalTrials.gov Identifier:
NCT01687387
First received: September 11, 2012
Last updated: March 4, 2014
Last verified: March 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

Contacts
Contact: Renaud Buffet, MD renaud.buffet@innate-pharma.fr
Contact: Robert Zerbib robert.zerbib@innate-pharma.fr

Locations
France
CHU d'Amiens Recruiting
Amiens, France, 80054
Principal Investigator: Jean-Pierre Marolleau         
CHU Angers Recruiting
Angers, France, 49933
Principal Investigator: Mathilde Hunault-Berger         
Centre hospitalier Victor Dupouy Recruiting
Argenteuil, France, 95107
Principal Investigator: Laurent Sutton         
Centre hospitalier de la côte Basque Recruiting
Bayonne, France, 64100
Principal Investigator: Anne Banos         
CHU de Besançon Recruiting
Besançon, France, 25030
Principal Investigator: Fabrice LAROSA         
CH de Blois Recruiting
Blois, France, 41000
Principal Investigator: Abderrazak EL YAMANI         
Hôpital Avicenne Recruiting
Bobigny, France, 93000
Principal Investigator: Claude Gardin         
Hôpital Morvan CHU Brest Recruiting
Brest, France, 29609
Principal Investigator: Gaëlle Guillerm         
CHG de Béziers Recruiting
Béziers, France, 34500
Principal Investigator: Alain Saad         
CH René Dubos Recruiting
Cergy Pontoise, France, 95303
Principal Investigator: Ioana-Dana Vaida         
Hôpital Militaire Percy Recruiting
Clamart, France, 92141
Principal Investigator: Jean-Valère Malfuson         
CHU Estaing Recruiting
Clermont-Ferrand, France, 63003
Principal Investigator: Romain Guieze         
Centre hospitalier sud francilien Not yet recruiting
Corbeil Essonnes, France, 91100
Principal Investigator: Stéphanie Haïat         
Hôpital Henri Mondor Recruiting
Créteil, France, 94010
Principal Investigator: Cécile Pautas         
CHU de Grenoble Recruiting
Grenoble, France, 38043
Principal Investigator: Claude-Eric Bulabois         
Centre Hospitalier de Versailles Recruiting
Le Chesnay Cedex, France, 78157
Principal Investigator: Philippe Rousselot         
Hôpital Claude Huriez Recruiting
Lille, France, 59037
Principal Investigator: Bruno Quesnel         
CHU de Limoges Recruiting
Limoges, France, 87042
Principal Investigator: Pascal Turlure         
Institut Paoli - Calmettes Recruiting
Marseille Cedex 09, France, 13273
Principal Investigator: Norbert Vey         
CH de Meaux Recruiting
Meaux, France, 77104
Principal Investigator: Jamilé Frayfer         
CHU Saint Eloi Recruiting
Montpellier Cedex 5, France, 34295
Principal Investigator: Yosr HICHRI         
Centre Hospitalier de Mulhouse Recruiting
Mulhouse, France, 68100
Principal Investigator: Mario Ojeda-Uribe         
CHU de Nantes Recruiting
Nantes, France, 44000
Principal Investigator: Jacques Delaunay         
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Principal Investigator: Lauris Gastaud         
CHU Caremeau Recruiting
Nîmes, France, 30029
Principal Investigator: Eric Jourdan         
CHR d'Orléans Recruiting
Orléans, France, 45067
Principal Investigator: Magda Alexis         
Hôpital Saint-Antoine Recruiting
Paris, France, 75012
Principal Investigator: Françoise Isnard         
Hôpital Saint-Louis Recruiting
Paris, France, 75010
Principal Investigator: Emmanuel Raffoux         
Hôpital Necker Recruiting
Paris Cedex 15, France, 75743
Principal Investigator: Olivier Hermine         
CH Saint-Jean Recruiting
Perpignan, France, 66000
Principal Investigator: Laurence Sanhes         
CHU de Bordeaux - Hôpital Haut-Lévêque Recruiting
Pessac, France, 33604
Principal Investigator: Arnaud Pigneux         
Centre hospitalier Lyon Sud Recruiting
Pierre Bénite, France, 69495
Principal Investigator: Xavier Thomas         
CHU de Poitiers Recruiting
Poitiers, France, 86021
Principal Investigator: François Guilhot         
CHR d'Annecy Recruiting
Pringy, France, 74374
Principal Investigator: Frédérique ORSINI-PIOCELLE         
CHU de Reims Recruiting
Reims, France, 51092
Principal Investigator: Chantal HIMBERLIN         
Centre Henri Becquerel Recruiting
Rouen, France, 76038
Principal Investigator: Stéphane Leprêtre         
Centre René Huguenin Recruiting
Saint-Cloud, France, 92210
Principal Investigator: Jacques Vargaftig         
CH Saint-Quentin Recruiting
Saint-Quentin, France, 02321
Principal Investigator: Réda Garidi         
Hôpital Haute Pierre et Hôpital Civil Recruiting
Strasbourg, France, 67098
Principal Investigator: Bruno Lioure         
CHU Purpan Recruiting
Toulouse, France, 31059
Principal Investigator: Christian Recher         
CH Valenciennes Recruiting
Valenciennes, France, 59322
Principal Investigator: José Fernandes         
CHU de Nancy Hôpitaux de Brabois Recruiting
Vandoeuvre Les Nancy, France, 54511
Principal Investigator: Caroline Bonmati         
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Principal Investigator: Jean-Henri Bourhis         
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: March 4, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Antibodies, Monoclonal
Pharmaceutical Solutions
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014