<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/NCT03280030</url>
  </required_header>
  <id_info>
    <org_study_id>CPKC412A2220</org_study_id>
    <nct_id>NCT03280030</nct_id>
  </id_info>
  <brief_title>A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML</brief_title>
  <official_title>A Phase II, Randomized, Double-blind, Multi-center, Placebo-controlled Study to Evaluate the Efficacy and Safety of Twice Daily Oral Midostaurin in Combination With Daunorubicin/Cytarabine Induction, High-dose Cytarabine Consolidation, and Midostaurin Single Agent Continuation Therapy in Newly Diagnosed Patients With FLT3-mutated Acute Myeloid Leukemia (AML).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy and safety of midostaurin in combination with&#xD;
      daunorubicin/cytarabine induction, high dose cytarabine consolidation and midostaurin single&#xD;
      agent continuation therapy in newly diagnosed patients with FLT3-mutated acute myeloid&#xD;
      leukemia (AML).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 6, 2018</start_date>
  <completion_date type="Actual">November 14, 2022</completion_date>
  <primary_completion_date type="Actual">March 11, 2020</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Safety Events (Part 1, Japan only)</measure>
    <time_frame>Day 21 of the first Consolidation cycle</time_frame>
    <description>Incidence and severity of Safety Events, defined as death or serious adverse event leading to treatment discontinuation that occurs on or before Day 21 of the first Consolidation cycle. This is is determined by the Independent Safety Committee to be definitely or probably related to midostaurin.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Event Free Survival (Part 2 - randomized, controlled)</measure>
    <time_frame>up to 3 years after last patient started treatment</time_frame>
    <description>Event Free survival defined as the time from the date of randomization until an EFS event is observed. An EFS event is defined as a failure to obtain a CR within an induction 2, relapse after CR, or death due to any cause, whichever occurs first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>up to 3 years after last patient started treatment</time_frame>
    <description>Overall survival defined as the time from the date of randomization to date of death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Remission</measure>
    <time_frame>up to 3 years after last patient started treatment</time_frame>
    <description>Complete Remission defined as the proportion of patients with a CR according to Chelson Criteria, at various timepoints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of relapse (CIR)</measure>
    <time_frame>up to 3 years after last patient started treatment</time_frame>
    <description>CIR (only for patients who have achieved CR after study treatment initiation), is measured from the date of first CR to relapse or death due to AML, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolite CGP52421</measure>
    <time_frame>Induction 1 Cycle 1 Day 8, Day 11, Day 15, Day 18 and Day 21, Consolidation Cycle 1 Day 8, Day 21, Cycle 3 Day 8, Day 21 Prior to first cycle of continuation cycle 1, Continuation Cycle 5, Continuation Cycle 9 and Completion Cycle 12</time_frame>
    <description>Evaluate the pharmacokinetic of major metabolite of midostaurin CGP52421</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolite CGP62221</measure>
    <time_frame>Induction 1 Cycle 1 Day 8, Day 11, Day 15, Day 18 and Day 21, Consolidation Cycle 1 Day 8, Day 21, Cycle 3 Day 8, Day 21 Prior to first cycle of continuation cycle 1, Continuation Cycle 5, Continuation Cycle 9 and Completion Cycle 12</time_frame>
    <description>Evaluate the pharmacokinetic of major metabolite of Midostaurin CGP62221.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QoL) per European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30</measure>
    <time_frame>Screening, D21 of each cycle of Induction and Consolidation; D1 of each cycle of Continuation, at end of treatment and during the post treatment follow up every 4 months during the first year</time_frame>
    <description>EORTC)QLQ-C30 total score and functional scales scores as determined by the score and absolute change from baseline at each scheduled assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (QoL) per Patient Global Impression of Change (PGIC)</measure>
    <time_frame>D21 of each cycle of Induction and Consolidation; D1 of each cycle of Continuation, at end of treatment and during the post treatment follow up every 4 months during the first year</time_frame>
    <description>PGIC score determined frequencies and percentages by scheduled timepoint.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>Midostaurin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will take study drug on day 8-21 during induction and consolidation phase; then continuously during continuation phase.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will take placebo on day 8-21 during induction and consolidation phase; then continuously during continuation phase.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midostaurin</intervention_name>
    <description>Midostaurin 50 mg [two 25 mg capsules] will be administered twice per day by mouth on day 8-21 during induction and consolidation phase; then continuously during continuation phase</description>
    <arm_group_label>Midostaurin</arm_group_label>
    <other_name>PKC412</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo two capsules will be administered twice per day by mouth on day 8-21 during induction and consolidation phase ; then continuously during continuation phase.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of AML (≥ 20% blasts in the bone marrow based on WHO 2016 classification).&#xD;
             Patients with APL (acute promyelocytic leukemia) with PML-RARA are not eligible&#xD;
&#xD;
          -  Documented presence of an ITD and/or TKD activating mutation in the FLT3 gene, as&#xD;
             determined by analysis in a Novartis designated laboratory An exception will be&#xD;
             patients who are enrolled into the part 1 in Japan, who may be treated with&#xD;
             midostaurin irrespective of AML FLT3 genotype.&#xD;
&#xD;
          -  Patients must meet the following laboratory value criteria that indicate adequate&#xD;
             organ function at the screening visit:&#xD;
&#xD;
               -  Estimated creatinine clearance ≥ 30 ml/min&#xD;
&#xD;
               -  Total bilirubin ≤ 1.5 x ULN, except in the setting of isolated Gilbert syndrome&#xD;
&#xD;
               -  Aspartate transaminase (AST) ≤ 3.0 x ULN&#xD;
&#xD;
               -  Alanine transaminase (ALT) ≤ 3.0 x ULN&#xD;
&#xD;
          -  Suitability for intensive chemotherapy in the judgment of the investigator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurologic symptoms suggestive of CNS leukemia unless CNS leukemia has been excluded&#xD;
             by a lumbar puncture. Patients with CSF fluid positive for AML blasts are not eligible&#xD;
&#xD;
          -  Developed therapy-related AML after prior radiotherapy (RT) or chemotherapy for&#xD;
             another cancer or disorder&#xD;
&#xD;
          -  Known hypersensitivity to midostaurin, cytarabine or daunorubicin or to any of the&#xD;
             excipients of midostaurin/placebo, cytarabine or daunorubicin&#xD;
&#xD;
          -  Abnormal chest X-ray unless the abnormality represents a non-active, or non-clinically&#xD;
             significant finding, such as scarring (subjects with controlled non active lung&#xD;
             infection are eligible)&#xD;
&#xD;
          -  Known impairment of gastrointestinal (GI) function or GI disease that might alter&#xD;
             significantly the absorption of midostaurin&#xD;
&#xD;
          -  Cardiac or cardiac repolarization abnormality&#xD;
&#xD;
          -  Pregnant or nursing (lactating) women&#xD;
&#xD;
          -  Women of child-bearing potential, unless they are using highly effective methods of&#xD;
             contraception during dosing and for 4 months after stopping medication Other&#xD;
             protocol-defined Inclusion/Exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nagoya-city</city>
        <state>Aichi</state>
        <zip>466-8650</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Toyoake city</city>
        <state>Aichi</state>
        <zip>470 1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kashiwa</city>
        <state>Chiba</state>
        <zip>277 8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Fukuoka city</city>
        <state>Fukuoka</state>
        <zip>812-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Fukushima city</city>
        <state>Fukushima</state>
        <zip>960 1295</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>064 0804</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Isehara</city>
        <state>Kanagawa</state>
        <zip>259-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kochi city</city>
        <state>Kochi</state>
        <zip>781 8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nagasaki-city</city>
        <state>Nagasaki</state>
        <zip>852-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Okayama city</city>
        <state>Okayama</state>
        <zip>701-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Osaka Sayama</city>
        <state>Osaka</state>
        <zip>589 8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Osaka-city</city>
        <state>Osaka</state>
        <zip>543-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hamamatsu</city>
        <state>Shizuoka</state>
        <zip>432-8580</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Shimotsuke</city>
        <state>Tochigi</state>
        <zip>329-0498</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bunkyo ku</city>
        <state>Tokyo</state>
        <zip>113-8677</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8603</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Shinagawa ku</city>
        <state>Tokyo</state>
        <zip>141 8625</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Aomori</city>
        <zip>030 8553</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>810-8563</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kyoto</city>
        <zip>606 8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Osaka</city>
        <zip>534-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Yamagata</city>
        <zip>990 9585</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <state>Seocho Gu</state>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kirov</city>
        <zip>610027</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>123182</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>125284</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Samara</city>
        <zip>443079</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>St Petersburg</city>
        <zip>194044</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Putzu City</city>
        <state>Chiayi Hsien</state>
        <zip>61363</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kaohsiung City</city>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Taipei</city>
        <zip>10002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Taoyuan</city>
        <zip>33305</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hanoi</city>
        <zip>100000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Russian Federation</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>April 18, 2023</last_update_submitted>
  <last_update_submitted_qc>April 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>midostaurin</keyword>
  <keyword>PKC412</keyword>
  <keyword>cytarabine</keyword>
  <keyword>daunorubicin</keyword>
  <keyword>acute myeloid leukemia</keyword>
  <keyword>combination treatment</keyword>
  <keyword>FLT3</keyword>
  <keyword>acute myeloid leukemia (AML)</keyword>
  <keyword>acute myelogenous leukemia (AML)</keyword>
  <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>Midostaurin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03280030
org study id: CPKC412A2220
nct id: NCT03280030
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the efficacy and safety of midostaurin in combination with
      daunorubicin/cytarabine induction, high dose cytarabine consolidation and midostaurin single
      agent continuation therapy in newly diagnosed patients with FLT3-mutated acute myeloid
      leukemia (AML).
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Incidence of Safety Events (Part 1, Japan only)
time frame: Day 21 of the first Consolidation cycle
description: Incidence and severity of Safety Events, defined as death or serious adverse event leading to treatment discontinuation that occurs on or before Day 21 of the first Consolidation cycle. This is is determined by the Independent Safety Committee to be definitely or probably related to midostaurin.
measure: Event Free Survival (Part 2 - randomized, controlled)
time frame: up to 3 years after last patient started treatment
description: Event Free survival defined as the time from the date of randomization until an EFS event is observed. An EFS event is defined as a failure to obtain a CR within an induction 2, relapse after CR, or death due to any cause, whichever occurs first.
measure: Overall Survival
time frame: up to 3 years after last patient started treatment
description: Overall survival defined as the time from the date of randomization to date of death due to any cause
measure: Complete Remission
time frame: up to 3 years after last patient started treatment
description: Complete Remission defined as the proportion of patients with a CR according to Chelson Criteria, at various timepoints
measure: Cumulative incidence of relapse (CIR)
time frame: up to 3 years after last patient started treatment
description: CIR (only for patients who have achieved CR after study treatment initiation), is measured from the date of first CR to relapse or death due to AML, whichever occurs first.
measure: Metabolite CGP52421
time frame: Induction 1 Cycle 1 Day 8, Day 11, Day 15, Day 18 and Day 21, Consolidation Cycle 1 Day 8, Day 21, Cycle 3 Day 8, Day 21 Prior to first cycle of continuation cycle 1, Continuation Cycle 5, Continuation Cycle 9 and Completion Cycle 12
description: Evaluate the pharmacokinetic of major metabolite of midostaurin CGP52421
measure: Metabolite CGP62221
time frame: Induction 1 Cycle 1 Day 8, Day 11, Day 15, Day 18 and Day 21, Consolidation Cycle 1 Day 8, Day 21, Cycle 3 Day 8, Day 21 Prior to first cycle of continuation cycle 1, Continuation Cycle 5, Continuation Cycle 9 and Completion Cycle 12
description: Evaluate the pharmacokinetic of major metabolite of Midostaurin CGP62221.
measure: Quality of life (QoL) per European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
time frame: Screening, D21 of each cycle of Induction and Consolidation; D1 of each cycle of Continuation, at end of treatment and during the post treatment follow up every 4 months during the first year
description: EORTC)QLQ-C30 total score and functional scales scores as determined by the score and absolute change from baseline at each scheduled assessment.
measure: Quality of life (QoL) per Patient Global Impression of Change (PGIC)
time frame: D21 of each cycle of Induction and Consolidation; D1 of each cycle of Continuation, at end of treatment and during the post treatment follow up every 4 months during the first year
description: PGIC score determined frequencies and percentages by scheduled timepoint.
arm group label: Midostaurin
arm group type: Experimental
description: Patients will take study drug on day 8-21 during induction and consolidation phase; then continuously during continuation phase.
arm group label: Placebo
arm group type: Placebo Comparator
description: Patients will take placebo on day 8-21 during induction and consolidation phase; then continuously during continuation phase.
intervention type: Drug
intervention name: Midostaurin
description: Midostaurin 50 mg [two 25 mg capsules] will be administered twice per day by mouth on day 8-21 during induction and consolidation phase; then continuously during continuation phase
arm group label: Midostaurin
other name: PKC412
intervention type: Drug
intervention name: Placebo
description: Placebo two capsules will be administered twice per day by mouth on day 8-21 during induction and consolidation phase ; then continuously during continuation phase.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
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country: Hong Kong
country: Japan
country: Korea, Republic of
country: Russian Federation
country: Taiwan
country: Thailand
country: Vietnam
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Midostaurin
sharing ipd: Undecided
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com