<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/NCT02204644</url>
  </required_header>
  <id_info>
    <org_study_id>HS-10096-301</org_study_id>
    <nct_id>NCT02204644</nct_id>
  </id_info>
  <brief_title>The Study of the Efficacy and the Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With CML</brief_title>
  <official_title>Randomized, Multi-center, Open-label Phase III Study of the Efficacy and Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu Hansoh Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu Hansoh Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to observe the efficacy and the safety of Flumatinib vs Imatinib as first line&#xD;
      treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia.&#xD;
&#xD;
      Randomized,Open Label,Control&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SIX-month major molecular response rate</measure>
    <time_frame>six months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>major molecular response rate</measure>
    <time_frame>3 months, 9 months and 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>CML, CML-CP,MMR,TKI</condition>
  <arm_group>
    <arm_group_label>Flumatinib mesylate tablets</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Flumatinib mesylate tablets 600mg qd for 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Imatinib mesylate tablets</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Imatinib mesylate tablets 400mg qd for 12months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Flumatinib 600mg qd</intervention_name>
    <arm_group_label>Flumatinib mesylate tablets</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Imatinib 400mg qd</intervention_name>
    <arm_group_label>Imatinib mesylate tablets</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women aged 18-75 year-old&#xD;
&#xD;
          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2&#xD;
&#xD;
          3. Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph +&#xD;
             CP-CML) within 6 months of diagnosis&#xD;
&#xD;
          4. Adequate organ function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. received TKIs drug treatment before enrollment&#xD;
&#xD;
          2. Central nervous system leukemia&#xD;
&#xD;
          3. Previous anti-CML therapy over two weeks (hydroxyurea, except anagrelide) or surgery&#xD;
             (including hematopoietic stem cell transplantation)&#xD;
&#xD;
          4. Cardiac dysfunction&#xD;
&#xD;
          5. Previous splenectomy&#xD;
&#xD;
          6. History of congenital or acquired bleeding disorders unrelated to CML&#xD;
&#xD;
          7. Previous malignancy except CML&#xD;
&#xD;
          8. Acute or chronic liver or severe kidney disease unrelated to CML&#xD;
&#xD;
          9. Pregnant, breastfeeding, child bearing potential but failed to take effective&#xD;
             contraception&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital of Blood Diseases, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300020</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>February 24, 2018</last_update_submitted>
  <last_update_submitted_qc>February 24, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Imatinib Mesylate</mesh_term>
    <mesh_term>Flumatinib</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02204644
org study id: HS-10096-301
nct id: NCT02204644
lead sponsor: 
has dmc: Yes
A study to observe the efficacy and the safety of Flumatinib vs Imatinib as first line
      treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia.

      Randomized,Open Label,Control
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: SIX-month major molecular response rate
time frame: six months
measure: major molecular response rate
time frame: 3 months, 9 months and 12 months
arm group label: Flumatinib mesylate tablets
arm group type: Experimental
description: Flumatinib mesylate tablets 600mg qd for 12 months
arm group label: Imatinib mesylate tablets
arm group type: Active Comparator
description: Imatinib mesylate tablets 400mg qd for 12months
intervention type: Drug
intervention name: Flumatinib 600mg qd
arm group label: Flumatinib mesylate tablets
intervention type: Drug
intervention name: Imatinib 400mg qd
arm group label: Imatinib mesylate tablets
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Imatinib Mesylate
mesh term: Flumatinib