<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01687387</url>
  </required_header>
  <id_info>
    <org_study_id>IPH2102-201</org_study_id>
    <nct_id>NCT01687387</nct_id>
  </id_info>
  <brief_title>Efficacy Study of Anti-KIR Monoclonal Antibody as Maintenance Treatment in Acute Myeloid Leukemia (EFFIKIR)</brief_title>
  <acronym>EFFIKIR</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Innate Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Innate Pharma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Double-Blind Placebo-Controlled Randomized Phase 2 Study evaluating the efficacy of lirilumab&#xD;
      (IPH2102/BMS-986015) as Maintenance Treatment administered in elderly patients with Acute&#xD;
      Myeloid Leukemia (AML) in first complete remission&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 17, 2016</completion_date>
  <primary_completion_date type="Actual">November 17, 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Leukemia-Free Survival</measure>
    <time_frame>from date of randomization until the date of first documented relapse, assessed up to 48 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <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</time_frame>
    <description>Number of Participants with Adverse Events based on full physical examination each treatment visit and collection of AEs</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">152</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>IPH2102 at 1 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>lirilumab (IPH2102/BMS986015) at 1 mg/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPH2102 at 0.1 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>lirilumab (IPH2102/BMS986015) at 0.1 mg/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Normal saline solution)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Normal saline solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IPH2102 at 0.1 mg/kg</intervention_name>
    <description>every 3 months</description>
    <arm_group_label>IPH2102 at 0.1 mg/kg</arm_group_label>
    <other_name>lirilumab/BMS986015</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>IPH2102 at 1 mg/kg</intervention_name>
    <description>every 4 weeks</description>
    <arm_group_label>IPH2102 at 1 mg/kg</arm_group_label>
    <other_name>lirilumab/BMS986015</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo (normal saline solution)</intervention_name>
    <description>every 4 weeks</description>
    <arm_group_label>IPH2102 at 0.1 mg/kg</arm_group_label>
    <arm_group_label>Placebo (Normal saline solution)</arm_group_label>
    <other_name>normal saline solution</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Primary or secondary Acute Myeloid Leukemia (AML, defined according to WHO 2008&#xD;
             criteria), in first CR/CRi (according to the revised recommendations of the&#xD;
             International Working Group for Diagnosis, Standardization of Response Criteria,&#xD;
             Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid&#xD;
             Leukemia J Clin Oncol. 2003 Dec 15; 21(24):4642-9 see appendix 19.3) following&#xD;
             induction chemotherapy and who received 1 or 2 consolidation cycles. Induction&#xD;
             chemotherapy should be performed within 6 months before randomization. Consolidation&#xD;
             cycle is defined as any chemotherapy administered within 3 months following CR and&#xD;
             including aracytine irrespective of the administered dose(s). A minimum of one and&#xD;
             maximum of 2 cycles should be administered before enrollment&#xD;
&#xD;
          2. Patients not eligible for an allogeneic hematopoietic cell transplantation&#xD;
&#xD;
          3. Age 60 to 80&#xD;
&#xD;
          4. ECOG Performance status of 0 or 1&#xD;
&#xD;
          5. Clinical laboratory values at screening&#xD;
&#xD;
               -  Calculated creatinine clearance (according to MDRD) &gt; 60 ml/min/1.73 m2&#xD;
&#xD;
               -  Platelet &gt; 75 x 109/l&#xD;
&#xD;
               -  Hemoglobin ≥ 10 g/dl supported or unsupported by transfusions&#xD;
&#xD;
               -  ANC &gt; 1 x 109/l&#xD;
&#xD;
               -  Total Bilirubin levels ≤ 1.5 ULN&#xD;
&#xD;
               -  ALT and AST ≤ 3 ULN&#xD;
&#xD;
          6. Recovery from acute toxicity of previous anti-tumor therapy&#xD;
&#xD;
          7. Male patients who accept and are able to use contraception methods recognized as&#xD;
             highly effective.&#xD;
&#xD;
          8. Signed informed consent prior to any protocol specific procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute Promyelocytic Leukemia with t (15; 17), or its molecular equivalents (PML-RARA)&#xD;
&#xD;
          2. Favorable risk AML corresponding defined as t(8;21) or inv (16) and t(16;16) and their&#xD;
             molecular equivalents (AML-ETO and CBFB-MYH11)&#xD;
&#xD;
          3. Last consolidation completed more than 3 months prior to first dosing&#xD;
&#xD;
          4. Concomitant treatment by chemotherapy, immunotherapy or by systemic corticosteroids&#xD;
&#xD;
          5. Within 28 days prior to first dosing: chemotherapy or systemic corticosteroid&#xD;
             treatment&#xD;
&#xD;
          6. History of allogeneic hematopoietic cell transplantation or solid organ&#xD;
             transplantation&#xD;
&#xD;
          7. History of high dose chemotherapy with autologous hematopoietic transplantation&#xD;
             performed as treatment for AML&#xD;
&#xD;
          8. Use of any investigational agent within 2 months prior to the first dosing&#xD;
&#xD;
          9. Use of growth factors (G- or GM-CSF or EPO) within 28 days prior to first dosing&#xD;
&#xD;
         10. Any irradiation within the last 3 months except for analgesic intent&#xD;
&#xD;
         11. Intermittent or continuous renal replacement therapy&#xD;
&#xD;
         12. Abnormal cardiac status with any of the following&#xD;
&#xD;
               -  Ejection fraction (measured by ultra-sound or radionuclide imaging) &lt;50%&#xD;
&#xD;
               -  Myocardial infarction within the previous 6 months&#xD;
&#xD;
               -  QTc ≥ 480 ms (Bazett's).&#xD;
&#xD;
         13. Current active infectious disease or positive serology for HIV, and/or HCV with&#xD;
             detectable viremia and/ or HBV with positive Hbs Antigen and/or negative anti Hbs&#xD;
             Antibody&#xD;
&#xD;
         14. Auto-immune disease:&#xD;
&#xD;
               -  Which currently or previously required systemic immunosuppressive or&#xD;
                  immuno-modulatory therapy (including corticosteroids administered by systemic&#xD;
                  route)&#xD;
&#xD;
               -  And/or has substantial probability to cause an irreversible injury to any tissue&#xD;
&#xD;
               -  And/or is recent or unstable or has substantial risk to progress and cause severe&#xD;
                  complications.&#xD;
&#xD;
         15. Serious concurrent uncontrolled medical disorder&#xD;
&#xD;
         16. History of another malignancy (apart from myelodysplastic syndromes, basal cell&#xD;
             carcinoma of the skin, or in situ cervix carcinoma) except if free of disease for ≥ 3&#xD;
             years&#xD;
&#xD;
         17. Any psychological, familial, sociological or geographical condition potentially&#xD;
             hampering compliance with the study protocol and follow-up schedule.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Norbert Vey, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Paoli Calmettes Marseille France</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hervé Dombret, MD</last_name>
    <role>Study Chair</role>
    <affiliation>ALFA cooperative Group</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Norbert Ifrah, MD</last_name>
    <role>Study Chair</role>
    <affiliation>GOELAMS Cooperative Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU d'Amiens</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier Victor Dupouy</name>
      <address>
        <city>Argenteuil</city>
        <zip>95107</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier de la côte Basque</name>
      <address>
        <city>Bayonne</city>
        <zip>64100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Besançon</name>
      <address>
        <city>Besançon</city>
        <zip>25030</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Blois</name>
      <address>
        <city>Blois</city>
        <zip>41000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Avicenne</name>
      <address>
        <city>Bobigny</city>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Morvan CHU Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHG de Béziers</name>
      <address>
        <city>Béziers</city>
        <zip>34500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH René Dubos</name>
      <address>
        <city>Cergy Pontoise</city>
        <zip>95303</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Militaire Percy</name>
      <address>
        <city>Clamart</city>
        <zip>92141</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Estaing</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier sud francilien</name>
      <address>
        <city>Corbeil Essonnes</city>
        <zip>91100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Henri Mondor</name>
      <address>
        <city>Créteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Versailles</name>
      <address>
        <city>Le Chesnay Cedex</city>
        <zip>78157</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Claude Huriez</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Limoges</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Paoli - Calmettes</name>
      <address>
        <city>Marseille Cedex 09</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Meaux</name>
      <address>
        <city>Meaux</city>
        <zip>77104</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Saint Eloi</name>
      <address>
        <city>Montpellier Cedex 5</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Mulhouse</name>
      <address>
        <city>Mulhouse</city>
        <zip>68100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne</name>
      <address>
        <city>Nice</city>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Caremeau</name>
      <address>
        <city>Nîmes</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR d'Orléans</name>
      <address>
        <city>Orléans</city>
        <zip>45067</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Necker</name>
      <address>
        <city>Paris Cedex 15</city>
        <zip>75743</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Louis</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint-Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Saint-Jean</name>
      <address>
        <city>Perpignan</city>
        <zip>66000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux - Hôpital Haut-Lévêque</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier Lyon Sud</name>
      <address>
        <city>Pierre Bénite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR d'Annecy</name>
      <address>
        <city>Pringy</city>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Reims</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Henri Becquerel</name>
      <address>
        <city>Rouen</city>
        <zip>76038</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre René Huguenin</name>
      <address>
        <city>Saint-Cloud</city>
        <zip>92210</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Saint-Quentin</name>
      <address>
        <city>Saint-Quentin</city>
        <zip>02321</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Haute Pierre et Hôpital Civil</name>
      <address>
        <city>Strasbourg</city>
        <zip>67098</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Purpan</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Valenciennes</name>
      <address>
        <city>Valenciennes</city>
        <zip>59322</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nancy Hôpitaux de Brabois</name>
      <address>
        <city>Vandoeuvre Les Nancy</city>
        <zip>54511</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <results_first_submitted>December 15, 2017</results_first_submitted>
  <results_first_submitted_qc>September 6, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 8, 2019</results_first_posted>
  <last_update_submitted>September 6, 2018</last_update_submitted>
  <last_update_submitted_qc>September 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>169 patients were screened and 152 patients were randomized and treated in France</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>IPH2102 at 1 mg/kg</title>
          <description>lirilumab (IPH2102/BMS986015) at 1 mg/kg&#xD;
IPH2102 at 1 mg/kg: every 4 weeks</description>
        </group>
        <group group_id="P2">
          <title>IPH2102 at 0.1 mg/kg</title>
          <description>lirilumab (IPH2102/BMS986015) at 0.1 mg/kg&#xD;
IPH2102 at 0.1 mg/kg: every 3 months&#xD;
Placebo (normal saline solution): every 4 weeks</description>
        </group>
        <group group_id="P3">
          <title>Placebo (Normal Saline Solution)</title>
          <description>Normal saline solution&#xD;
Placebo (normal saline solution): every 4 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="50"/>
                <participants group_id="P3" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="38"/>
                <participants group_id="P3" count="38"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>IPH2102 at 1 mg/kg</title>
          <description>lirilumab (IPH2102/BMS986015) at 1 mg/kg&#xD;
IPH2102 at 1 mg/kg: every 4 weeks</description>
        </group>
        <group group_id="B2">
          <title>IPH2102 at 0.1 mg/kg</title>
          <description>lirilumab (IPH2102/BMS986015) at 0.1 mg/kg&#xD;
IPH2102 at 0.1 mg/kg: every 3 months&#xD;
Placebo (normal saline solution): every 4 weeks</description>
        </group>
        <group group_id="B3">
          <title>Placebo (Normal Saline Solution)</title>
          <description>Normal saline solution&#xD;
Placebo (normal saline solution): every 4 weeks</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="51"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="51"/>
            <count group_id="B4" value="152"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70" lower_limit="60" upper_limit="80"/>
                    <measurement group_id="B2" value="70" lower_limit="60" upper_limit="80"/>
                    <measurement group_id="B3" value="68" lower_limit="60" upper_limit="77"/>
                    <measurement group_id="B4" value="70" lower_limit="60" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="34"/>
                    <measurement group_id="B4" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                    <count group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="51"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="51"/>
                    <count group_id="B4" value="152"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Leukemia-Free Survival</title>
        <time_frame>from date of randomization until the date of first documented relapse, assessed up to 48 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IPH2102 at 1 mg/kg</title>
            <description>lirilumab (IPH2102/BMS986015) at 1 mg/kg&#xD;
IPH2102 at 1 mg/kg: every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>IPH2102 at 0.1 mg/kg</title>
            <description>lirilumab (IPH2102/BMS986015) at 0.1 mg/kg&#xD;
IPH2102 at 0.1 mg/kg: every 3 months&#xD;
Placebo (normal saline solution): every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Normal Saline Solution)</title>
            <description>Normal saline solution&#xD;
Placebo (normal saline solution): every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Leukemia-Free Survival</title>
          <units>MONTHS</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" lower_limit="2.9" upper_limit="14.8"/>
                    <measurement group_id="O2" value="17.6" lower_limit="11.2" upper_limit="25"/>
                    <measurement group_id="O3" value="13.9" lower_limit="7.9" upper_limit="27.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>Number of Participants with Adverse Events based on full physical examination each treatment visit and collection of AEs</description>
        <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</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IPH2102 at 1 mg/kg</title>
            <description>lirilumab (IPH2102/BMS986015) at 1 mg/kg&#xD;
IPH2102 at 1 mg/kg: every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>IPH2102 at 0.1 mg/kg</title>
            <description>lirilumab (IPH2102/BMS986015) at 0.1 mg/kg&#xD;
IPH2102 at 0.1 mg/kg: every 3 months&#xD;
Placebo (normal saline solution): every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Placebo (Normal Saline Solution)</title>
            <description>Normal saline solution&#xD;
Placebo (normal saline solution): every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>Number of Participants with Adverse Events based on full physical examination each treatment visit and collection of AEs</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="50"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="49"/>
                    <measurement group_id="O3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs and SAEs will be collected throughout the study from the time of patient signing the consent form until 28 days after the last administration, or until the patient's last study visit</time_frame>
      <group_list>
        <group group_id="E1">
          <title>IPH2102 at 1 mg/kg</title>
          <description>lirilumab (IPH2102/BMS986015) at 1 mg/kg&#xD;
IPH2102 at 1 mg/kg: every 4 weeks</description>
        </group>
        <group group_id="E2">
          <title>IPH2102 at 0.1 mg/kg</title>
          <description>lirilumab (IPH2102/BMS986015) at 0.1 mg/kg&#xD;
IPH2102 at 0.1 mg/kg: every 3 months&#xD;
Placebo (normal saline solution): every 4 weeks</description>
        </group>
        <group group_id="E3">
          <title>Placebo (Normal Saline Solution)</title>
          <description>Normal saline solution&#xD;
Placebo (normal saline solution): every 4 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Hydrocele</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Chorioretinal disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal wall haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Sialoadenitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Injury corneal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Biopsy spleen</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Chondrocalcinosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Invasive lobular breast carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Lung cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Myxofibrosarcoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Papillary thyroid cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Polycythaemia vera</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Rectal adenocarcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acute febrile neutrophilic dermatosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Respiratory therapy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="50"/>
                <counts group_id="E3" subjects_affected="43" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E3" events="11" subjects_affected="5" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="51"/>
                <counts group_id="E2" events="11" subjects_affected="7" subjects_at_risk="50"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="51"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="14" subjects_at_risk="51"/>
                <counts group_id="E2" events="19" subjects_affected="14" subjects_at_risk="50"/>
                <counts group_id="E3" events="22" subjects_affected="14" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="51"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E3" events="9" subjects_affected="5" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="51"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="51"/>
                <counts group_id="E2" events="20" subjects_affected="17" subjects_at_risk="50"/>
                <counts group_id="E3" events="15" subjects_affected="14" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="8" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" events="7" subjects_affected="5" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="51"/>
                <counts group_id="E2" events="9" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="51"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="51"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="51"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="51"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="50"/>
                <counts group_id="E3" events="12" subjects_affected="7" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="51"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director Clinical Operations</name_or_title>
      <organization>Innate Pharma</organization>
      <phone>+33043030 ext 30</phone>
      <email>info@innate-pharma.fr</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01687387
org study id: IPH2102-201
nct id: NCT01687387
lead sponsor: 
has dmc: Yes
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Leukemia-Free Survival
time frame: from date of randomization until the date of first documented relapse, assessed up to 48 months
measure: Number of Participants With 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
description: Number of Participants with Adverse Events based on full physical examination each treatment visit and collection of AEs
arm group label: IPH2102 at 1 mg/kg
arm group type: Experimental
description: lirilumab (IPH2102/BMS986015) at 1 mg/kg
arm group label: IPH2102 at 0.1 mg/kg
arm group type: Experimental
description: lirilumab (IPH2102/BMS986015) at 0.1 mg/kg
arm group label: Placebo (Normal saline solution)
arm group type: Placebo Comparator
description: Normal saline solution
intervention type: Drug
intervention name: IPH2102 at 0.1 mg/kg
description: every 3 months
arm group label: IPH2102 at 0.1 mg/kg
other name: lirilumab/BMS986015
intervention type: Drug
intervention name: IPH2102 at 1 mg/kg
description: every 4 weeks
arm group label: IPH2102 at 1 mg/kg
other name: lirilumab/BMS986015
intervention type: Drug
intervention name: Placebo (normal saline solution)
description: every 4 weeks
arm group label: IPH2102 at 0.1 mg/kg
arm group label: Placebo (Normal saline solution)
other name: normal saline solution
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: No
last name: Norbert Vey, MD
role: Principal Investigator
affiliation: Institut Paoli Calmettes Marseille France
last name: Hervé Dombret, MD
role: Study Chair
affiliation: ALFA cooperative Group
last name: Norbert Ifrah, MD
role: Study Chair
affiliation: GOELAMS Cooperative Group
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country: France
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Pharmaceutical Solutions
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