<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/NCT03014102</url>
  </required_header>
  <id_info>
    <org_study_id>LC2016B03</org_study_id>
    <nct_id>NCT03014102</nct_id>
  </id_info>
  <brief_title>Recombinant Human Thrombopoietin for Mobilization of Peripheral Blood Progenitor Cells for Autologous Transplantation</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hongnan Mo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether recombinant human thrombopoietin are&#xD;
      effective in peripheral blood progenitor cells mobilization for autologous transplantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the average number of cluster of differentiation 34 positive cells/kg</measure>
    <time_frame>up to 24 months</time_frame>
    <description>To evaluate the effect of combining various treatment schedules of recombinant human thrombopoietin with granulocyte colony stimulating factor on the mobilization of peripheral blood progenitor cells.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Thrombocytopoietin</condition>
  <condition>Hematopoietic Stem Cell Mobilization</condition>
  <condition>Hematopoietic Stem Cell Transplantation</condition>
  <arm_group>
    <arm_group_label>TPOqd</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Recombinant Human Thrombopoietin 300U/kg/d ih quaque die, day-3/-2/-1 before mobilization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TPOqod</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Recombinant Human Thrombopoietin 300U/kg/d ih qua altera die, day-3/-1/+2 before mobilization</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Recombinant Human Thrombopoietin</intervention_name>
    <description>Recombinant human Thrombopoietin is a full length glycosylated molecule identical to endogenous Thrombopoietin.</description>
    <arm_group_label>TPOqd</arm_group_label>
    <arm_group_label>TPOqod</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a histologically confirmed diagnosis of Hodgkin's disease, non-Hodgkin's lymphoma, or&#xD;
             selected high-risk solid tumors that are planned to receive autologous peripheral&#xD;
             blood progenitor cell transplantation&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status of 0 - 2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  abnormal liver function (aminotransferase or bilirubin levels 2 times upper limit of&#xD;
             normal), leukopenia (white blood cell count 3000/L), or a history of platelet or other&#xD;
             disorders associated with a bleeding diathesis&#xD;
&#xD;
          -  a history of thromboembolic disease, coronary heart disease,stroke, arrhythmias,&#xD;
             central nervous system metastases,or other organ system diseases or abnormalities that&#xD;
             might predispose individuals to treatment-related complications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hongnan Mo, MD</last_name>
    <phone>8610-87787451</phone>
    <email>mhnzlyynk@outlook.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cancer Hospital, Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongnan Mo, MD</last_name>
      <phone>8610-87788103</phone>
      <email>mhnzlyynk@outlook.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>December 5, 2019</last_update_submitted>
  <last_update_submitted_qc>December 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Hongnan Mo</investigator_full_name>
    <investigator_title>Attending Physician</investigator_title>
  </responsible_party>
  <!-- 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/NCT03014102
org study id: LC2016B03
nct id: NCT03014102
lead sponsor: 
The purpose of this study is to determine whether recombinant human thrombopoietin are
      effective in peripheral blood progenitor cells mobilization for autologous transplantation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: the average number of cluster of differentiation 34 positive cells/kg
time frame: up to 24 months
description: To evaluate the effect of combining various treatment schedules of recombinant human thrombopoietin with granulocyte colony stimulating factor on the mobilization of peripheral blood progenitor cells.
arm group label: TPOqd
arm group type: Experimental
description: Recombinant Human Thrombopoietin 300U/kg/d ih quaque die, day-3/-2/-1 before mobilization
arm group label: TPOqod
arm group type: Active Comparator
description: Recombinant Human Thrombopoietin 300U/kg/d ih qua altera die, day-3/-1/+2 before mobilization
intervention type: Drug
intervention name: Recombinant Human Thrombopoietin
description: Recombinant human Thrombopoietin is a full length glycosylated molecule identical to endogenous Thrombopoietin.
arm group label: TPOqd
arm group label: TPOqod
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Hongnan Mo, MD
phone: 8610-87787451
email: mhnzlyynk@outlook.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Hongnan Mo
investigator title: Attending Physician