<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/NCT02977312</url>
  </required_header>
  <id_info>
    <org_study_id>Cemivil-2011-01</org_study_id>
    <nct_id>NCT02977312</nct_id>
  </id_info>
  <brief_title>Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan</brief_title>
  <acronym>CCMLJ</acronym>
  <official_title>Observational Study of Cemivil® (Imatinib) in Chronic Myeloid Leukemia Patients in Jordan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hikma Pharmaceuticals LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hikma Pharmaceuticals LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study assessed the efficacy and safety of generic imatinib in patients with chronic&#xD;
      myeloid leukemia (CML) in Jordan. It was a multicenter, non-interventional, open-label,&#xD;
      prospective study combined with retrospective data collection from files of patients with a&#xD;
      diagnosis of Ph+ CML, treated with Cemivil (imatinib), where no visits or intervention(s)&#xD;
      additional to the daily practice were performed&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary objectives&#xD;
&#xD;
      Measure the proportion of Philadelphia chromosome positive (Ph+) CML patients in CP treated&#xD;
      with Cemivil who achieve optimal response :&#xD;
&#xD;
        -  Complete hematologic response (CHR) at 3 months;&#xD;
&#xD;
        -  Minor cytogenetic response (mCyR) at 3 months (Ph+ ≤65%); partial cytogenetic response&#xD;
           (PCyR) at 6 months (Ph+ ≤35%), and complete cytogenetic response (CCyR) at 12 months (No&#xD;
           Ph+ metaphases);&#xD;
&#xD;
        -  Major molecular response (MMR) at 12 months of Cemivil therapy [a ratio of BCR-ABL1 to&#xD;
           ABL1 ≤0.1% on the International Scale];&#xD;
&#xD;
      Assess the safety and tolerability of Cemivil after one year of treatment, based on:&#xD;
&#xD;
        -  Incidence, severity, and relationship of adverse events (AEs) to the study medication;&#xD;
&#xD;
        -  Serious AEs;&#xD;
&#xD;
        -  AEs leading to permanent treatment discontinuation;&#xD;
&#xD;
        -  Clinically relevant changes in laboratory tests (according to laboratory reference&#xD;
           ranges).&#xD;
&#xD;
      Number of Subjects evaluated: 91 (N=33 received generic imatinib as first-line therapy&#xD;
      &quot;first-line patients&quot;. N=58 switched from patented imatinib to generic imatinib &quot;switched&#xD;
      patients&quot;)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Complete Cytogenetic Response (CCyR)</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Major Molecular Response (MMR)</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of treatment-emergent adverse events (AEs)</measure>
    <time_frame>12 months</time_frame>
    <description>(Safety &amp; Tolerability)</description>
  </secondary_outcome>
  <enrollment type="Actual">91</enrollment>
  <condition>Chronic Myeloid Leukemia, Chronic Phase</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Imatinib</intervention_name>
    <description>Observation of chronic myeloid leukemia (CML) patients in chronic phase (CP) treated with Cemivil</description>
    <other_name>Cemivil</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) patients in chronic&#xD;
        phase (CP)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Newly diagnosed patients with Ph+ CML in CP; or CML patients who started with Cemivil&#xD;
             treatment since its registration in Jordan and who confirmed CHR&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  CML in accelerated phase&#xD;
&#xD;
          -  CML in blast crisis&#xD;
&#xD;
          -  CML with mutation(s) in the BCR-ABL gene&#xD;
&#xD;
          -  Contraindications to the administration of the study drug according to the approved&#xD;
             Summary of Product Characteristics (SPC)&#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>Abdallah Abbadi, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jordan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Al Bashir Hospital</name>
      <address>
        <city>Amman</city>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jordan University Hospital</name>
      <address>
        <city>Amman</city>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King Hussein Cancer Center</name>
      <address>
        <city>Amman</city>
        <country>Jordan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Jordan</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 29, 2016</last_update_submitted>
  <last_update_submitted_qc>November 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2016</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02977312
org study id: Cemivil-2011-01
nct id: NCT02977312
lead sponsor: 
has dmc: No
This study assessed the efficacy and safety of generic imatinib in patients with chronic
      myeloid leukemia (CML) in Jordan. It was a multicenter, non-interventional, open-label,
      prospective study combined with retrospective data collection from files of patients with a
      diagnosis of Ph+ CML, treated with Cemivil (imatinib), where no visits or intervention(s)
      additional to the daily practice were performed
Primary objectives

      Measure the proportion of Philadelphia chromosome positive (Ph+) CML patients in CP treated
      with Cemivil who achieve optimal response :

        -  Complete hematologic response (CHR) at 3 months;

        -  Minor cytogenetic response (mCyR) at 3 months (Ph+ ≤65%); partial cytogenetic response
           (PCyR) at 6 months (Ph+ ≤35%), and complete cytogenetic response (CCyR) at 12 months (No
           Ph+ metaphases);

        -  Major molecular response (MMR) at 12 months of Cemivil therapy [a ratio of BCR-ABL1 to
           ABL1 ≤0.1% on the International Scale];

      Assess the safety and tolerability of Cemivil after one year of treatment, based on:

        -  Incidence, severity, and relationship of adverse events (AEs) to the study medication;

        -  Serious AEs;

        -  AEs leading to permanent treatment discontinuation;

        -  Clinically relevant changes in laboratory tests (according to laboratory reference
           ranges).

      Number of Subjects evaluated: 91 (N=33 received generic imatinib as first-line therapy
      "first-line patients". N=58 switched from patented imatinib to generic imatinib "switched
      patients")
observational model: Cohort
measure: Rate of Complete Cytogenetic Response (CCyR)
time frame: 12 months
measure: Rate of Major Molecular Response (MMR)
time frame: 12 months
measure: Incidence of treatment-emergent adverse events (AEs)
time frame: 12 months
description: (Safety & Tolerability)
intervention type: Drug
intervention name: Imatinib
description: Observation of chronic myeloid leukemia (CML) patients in chronic phase (CP) treated with Cemivil
other name: Cemivil
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Abdallah Abbadi, Professor
role: Principal Investigator
affiliation: Jordan University Hospital
facility: 
facility: 
facility: 
country: Jordan
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
mesh term: Imatinib Mesylate
sharing ipd: No