<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/NCT02204722</url>
  </required_header>
  <id_info>
    <org_study_id>IMA_CML_IV</org_study_id>
    <nct_id>NCT02204722</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Efficacy and Safety of Glinib in Newly Diagnosed CML Patients</brief_title>
  <acronym>IDEAL</acronym>
  <official_title>A Phase IV Study to Evaluate Efficacy and Safety of Imatinib(Glinib®) 600mg/Day Depending on Early Molecular Response in Newly Diagnosed Patients With Chronic Myeloid Leukemia in Chronic Phase</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dong-A ST Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SeoulCRO</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dong-A ST Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to evaluate efficacy and safety of Imatinib in two groups of patients; all&#xD;
      patients should be diagnosed less than 3 months as chronic myeloid leukemia in a chronic&#xD;
      phase. The group A, the reference group, will have 10% or less than 10% of the BCR-ABL level&#xD;
      after three month dosing and be maintained their dose of 400mg/day. On the other hand, the&#xD;
      group B, will have more than 10% and the dose will be increased from 400mg/day to 600mg/day.&#xD;
      The superiority of the group B will be proved by evaluating the MMR rate of these two groups&#xD;
      after 12 months of administeration of Imatinib.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor's decision to halt the study.&#xD;
  </why_stopped>
  <start_date type="Actual">October 13, 2014</start_date>
  <completion_date type="Actual">January 9, 2018</completion_date>
  <primary_completion_date type="Actual">May 23, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MMR rate at 12 months in two groups</measure>
    <time_frame>12 months</time_frame>
    <description>MMR rate at 12 months in two groups will be compared. Group A is consisted of patients with equal or less than 10% of BDR-ABL, Group B is consisted of patients with more than 10% of BDR-ABL.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CCyR in group A and B</measure>
    <time_frame>12 months</time_frame>
    <description>CCyR rate for 12 months and the duration of the complete CCyR will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MMR in group A and B</measure>
    <time_frame>12 months</time_frame>
    <description>MMR rate for 12 months and the duration of MMR will be measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CMR in group A and B</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival rate in group A and B</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression rate to AP/BC in group A and B</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the actual administration</measure>
    <time_frame>12 months</time_frame>
    <description>the total dose will be divided by total days of the treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Chronic Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the group who has more than 10% of the BCR-ABL(IS) level for three months will receive 600mg/day of Imatinib after three months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the group who has more than 10% of the BCR-ABL(IS) level for three months will maintain the dose, 400mg/day of Imatinib, after three months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>600mg/day of Imatinib</intervention_name>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>400mg/day of Imatinib</intervention_name>
    <arm_group_label>Group A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at the age of 18 or more&#xD;
&#xD;
          -  newly diagnosed within three months as a Chronic Myeloid Leukemia&#xD;
&#xD;
          -  with positive Philadelphia chromosome and appearance of BCR-ABL transcript&#xD;
&#xD;
          -  with 0 - 2 of ECOG Performance Status&#xD;
&#xD;
          -  with normal renal function&#xD;
&#xD;
          -  with normal hepatic function&#xD;
&#xD;
          -  able to understand and decide to involve the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of radiation therapy for more than 25% of bone marrow due to other malignant&#xD;
             diseases&#xD;
&#xD;
          -  history of other clinically relevant malignant tumors&#xD;
&#xD;
          -  with bleeding disorders which are not related to leukemia&#xD;
&#xD;
          -  evidence of clinically relevant cardiac dysfunction&#xD;
&#xD;
          -  with severe disease which cannot be regulated by other organs&#xD;
&#xD;
          -  a previous administration of Imatinib more than a week prior to the first dose.&#xD;
&#xD;
          -  participation in other drug study(eg. intervention trial) within 30 days prior to the&#xD;
             screening visit&#xD;
&#xD;
          -  HIV-infected&#xD;
&#xD;
          -  females with pregnancy, childbearing or lactating potential&#xD;
&#xD;
          -  other reasons determined by investigators&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyu-Hyoung Lee, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jin-hee Park, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gachon University Gil Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chul-won Choi, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University Guro Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sae-ryun Lee, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University Ansan Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yong Park, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University Anam Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joo-sup Joeng, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pusan National University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jung-ok Lee, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chul-won Jung, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sung-soo Yoon, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kyung-ha Kim, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Soonchunhyang University Hospital Seoul</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joon-sung Park, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ajou University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Duk-yeon Cho, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chungnam National University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sung-nam Im, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inje University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>138736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2018</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>June 14, 2018</last_update_submitted>
  <last_update_submitted_qc>June 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2018</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, Myelogenous, Chronic, BCR-ABL Positive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Imatinib Mesylate</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/NCT02204722
org study id: IMA_CML_IV
nct id: NCT02204722
lead sponsor: 
collaborator: 
has dmc: No
This study is to evaluate efficacy and safety of Imatinib in two groups of patients; all
      patients should be diagnosed less than 3 months as chronic myeloid leukemia in a chronic
      phase. The group A, the reference group, will have 10% or less than 10% of the BCR-ABL level
      after three month dosing and be maintained their dose of 400mg/day. On the other hand, the
      group B, will have more than 10% and the dose will be increased from 400mg/day to 600mg/day.
      The superiority of the group B will be proved by evaluating the MMR rate of these two groups
      after 12 months of administeration of Imatinib.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MMR rate at 12 months in two groups
time frame: 12 months
description: MMR rate at 12 months in two groups will be compared. Group A is consisted of patients with equal or less than 10% of BDR-ABL, Group B is consisted of patients with more than 10% of BDR-ABL.
measure: CCyR in group A and B
time frame: 12 months
description: CCyR rate for 12 months and the duration of the complete CCyR will be evaluated.
measure: MMR in group A and B
time frame: 12 months
description: MMR rate for 12 months and the duration of MMR will be measured.
measure: CMR in group A and B
time frame: 12 months
measure: Survival rate in group A and B
time frame: 12 months
measure: Progression rate to AP/BC in group A and B
time frame: 12 months
measure: the actual administration
time frame: 12 months
description: the total dose will be divided by total days of the treatment.
arm group label: Group B
arm group type: Experimental
description: the group who has more than 10% of the BCR-ABL(IS) level for three months will receive 600mg/day of Imatinib after three months.
arm group label: Group A
arm group type: Experimental
description: the group who has more than 10% of the BCR-ABL(IS) level for three months will maintain the dose, 400mg/day of Imatinib, after three months.
intervention type: Drug
intervention name: 600mg/day of Imatinib
arm group label: Group B
intervention type: Drug
intervention name: 400mg/day of Imatinib
arm group label: Group A
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kyu-Hyoung Lee, M.D.
role: Principal Investigator
affiliation: Asan Medical Center
last name: Jin-hee Park, M.D.
role: Principal Investigator
affiliation: Gachon University Gil Medical Center
last name: Chul-won Choi, M.D.
role: Principal Investigator
affiliation: Korea University Guro Hospital
last name: Sae-ryun Lee, M.D.
role: Principal Investigator
affiliation: Korea University Ansan Hospital
last name: Yong Park, M.D.
role: Principal Investigator
affiliation: Korea University Anam Hospital
last name: Joo-sup Joeng, M.D.
role: Principal Investigator
affiliation: Pusan National University Hospital
last name: Jung-ok Lee, M.D.
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
last name: Chul-won Jung, M.D.
role: Principal Investigator
affiliation: Seoul Medical Center
last name: Sung-soo Yoon, M.D.
role: Principal Investigator
affiliation: Seoul National University Hospital
last name: Kyung-ha Kim, M.D.
role: Principal Investigator
affiliation: Soonchunhyang University Hospital Seoul
last name: Joon-sung Park, M.D.
role: Principal Investigator
affiliation: Ajou University School of Medicine
last name: Duk-yeon Cho, M.D.
role: Principal Investigator
affiliation: Chungnam National University Hospital
last name: Sung-nam Im, M.D.
role: Principal Investigator
affiliation: Inje University
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
mesh term: Imatinib Mesylate