<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/NCT03228303</url>
  </required_header>
  <id_info>
    <org_study_id>Jgmaxwell</org_study_id>
    <nct_id>NCT03228303</nct_id>
  </id_info>
  <brief_title>Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia</brief_title>
  <official_title>Nilotinib Versus Imatinib in Treatment of Patients With Newly Diagnosed Chronic Myeloid Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nilotinib vs imatinib in patients with newly diagnosed CML-CP&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study size is 100 patients in 2 arms 50 patients in nilotinib ttt 50 patients in imatinib ttt&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2017</start_date>
  <completion_date type="Anticipated">August 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2020</primary_completion_date>
  <phase>Early Phase 1</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Overall survival rate in years</measure>
    <time_frame>3 years cutoff</time_frame>
    <description>Overall survival rate in years</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Cholesterol level in mg</measure>
    <time_frame>3 years cutoff</time_frame>
    <description>cholesterol level in mg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Heart state by assessment by ECG</measure>
    <time_frame>3 years cutoff</time_frame>
    <description>heart state by assessment by ECG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Free survival rate in years</measure>
    <time_frame>3 years cutoff</time_frame>
    <description>free survival rate in years</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Chronic Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>Chronic phase CML treated by nilotinib</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Newly diagnosed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic phase CML treated by imatinib</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Newly diagnosed</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nilotinib 150 MG [Tasigna]</intervention_name>
    <description>Nilotinib vs imatinib in patients with newly diagnosed CML-CP</description>
    <arm_group_label>Chronic phase CML treated by nilotinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Imatinib 400mg</intervention_name>
    <description>Nilotinib vs imatinib in patients with newly diagnosed CML-CP</description>
    <arm_group_label>Chronic phase CML treated by imatinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic phase CML not received treatment&#xD;
&#xD;
          -  Pts with no heart disease&#xD;
&#xD;
          -  Pts with no abnormal cholesterol level&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any pts treated before with diff. Treatment&#xD;
&#xD;
          -  Pts. With past history of heart problems&#xD;
&#xD;
          -  Pts. With abnormal cholesterol level&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 16, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>October 7, 2017</last_update_submitted>
  <last_update_submitted_qc>October 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Jean George Maxwell</investigator_full_name>
    <investigator_title>ClinIcal professor</investigator_title>
  </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/NCT03228303
org study id: Jgmaxwell
nct id: NCT03228303
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Nilotinib vs imatinib in patients with newly diagnosed CML-CP
Study size is 100 patients in 2 arms 50 patients in nilotinib ttt 50 patients in imatinib ttt
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Overall survival rate in years
time frame: 3 years cutoff
description: Overall survival rate in years
measure: Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Cholesterol level in mg
time frame: 3 years cutoff
description: cholesterol level in mg
measure: Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Heart state by assessment by ECG
time frame: 3 years cutoff
description: heart state by assessment by ECG
measure: Nilotinib vs imatinib in patients with newly diagnosed CML-CP: Free survival rate in years
time frame: 3 years cutoff
description: free survival rate in years
arm group label: Chronic phase CML treated by nilotinib
arm group type: Active Comparator
description: Newly diagnosed
arm group label: Chronic phase CML treated by imatinib
arm group type: Active Comparator
description: Newly diagnosed
intervention type: Drug
intervention name: Nilotinib 150 MG [Tasigna]
description: Nilotinib vs imatinib in patients with newly diagnosed CML-CP
arm group label: Chronic phase CML treated by nilotinib
intervention type: Drug
intervention name: Imatinib 400mg
description: Nilotinib vs imatinib in patients with newly diagnosed CML-CP
arm group label: Chronic phase CML treated by imatinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Jean George Maxwell
investigator title: ClinIcal professor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
mesh term: Imatinib Mesylate