<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/NCT02244658</url>
  </required_header>
  <id_info>
    <org_study_id>RhTPO-AML thrombocytopenia</org_study_id>
    <nct_id>NCT02244658</nct_id>
  </id_info>
  <brief_title>Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia</brief_title>
  <official_title>Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia: a Multicenter Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chemotherapy-related myelosuppression usually occurs in AML patients, which induces severe&#xD;
      thrombocytopenia and haemorrhage, a leading cause of death. This clinical trial aims at&#xD;
      evaluating efficacy and safety of rhTPO in management of chemotherapy-induced&#xD;
      thrombocytopenia in acute myelocytic leukemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are undertaking a parallel group, multicentre, randomized controlled trial&#xD;
      of 80 adults with chemotherapy-induced thrombocytopenia from 8 medical centers in China. AML&#xD;
      patients with PLT count &lt;30×10^9/L during the previous cycle of chemotherapy are randomized&#xD;
      into two groups that one receives rhTPO at 1.0μg/kg·d subcutaneously for 7~14 consecutive&#xD;
      days and the other receives no rhTPO or other thrombopoietic factor. Platelet count, bleeding&#xD;
      and other symptoms were evaluated before and after treatment. Adverse events are also&#xD;
      recorded throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">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>Evaluation of platelet response</measure>
    <time_frame>21 days since the first administration</time_frame>
    <description>days that PLT count rebound to 30×10^9/L, 50×10^9/L and 100×10^9/L, respectively, from the minimal level after the very cycle of chemotherapy.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Antineoplastic Adverse Reaction</condition>
  <condition>Thrombocytopenia</condition>
  <condition>Acute Myelocytic Leukemia</condition>
  <arm_group>
    <arm_group_label>rhTPO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>rhTPO 1.0 μg/kg·d subcutaneously for 7~14 consecutive days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>no thrombopoietic agents</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rhTPO</intervention_name>
    <description>rhTPO 1.0 μg/kg·d subcutaneously for 7~14 consecutive days</description>
    <arm_group_label>rhTPO</arm_group_label>
    <other_name>TPIAO</other_name>
    <other_name>S20050048/49 (SFDA, China)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AML patients with PLT count &lt;30×10^9/L during the previous cycle of chemotherapy to&#xD;
             minimize the risk of clinically significant bleeding.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergic history to biological agents; history of thrombotic or hemorrhagic diseases;&#xD;
             M3 or M7 subtype; pregnancy; hypertension; cardiovascular disease; diabetes; liver and&#xD;
             kidney function impairment;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ming Hou</last_name>
    <email>houming@medmail.com.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Qilu hospital, Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ming Hou</last_name>
      <email>houming@medmail.com.cn</email>
    </contact>
    <investigator>
      <last_name>Ming Hou</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 13, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>April 18, 2016</last_update_submitted>
  <last_update_submitted_qc>April 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Ming Hou</investigator_full_name>
    <investigator_title>Professor and Director</investigator_title>
  </responsible_party>
  <keyword>chemotherapy-induced thrombocytopenia</keyword>
  <keyword>recombinant human thrombopoietin</keyword>
  <keyword>acute myelocytic leukemia</keyword>
  <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, Myeloid, Acute</mesh_term>
    <mesh_term>Thrombocytopenia</mesh_term>
  </condition_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/NCT02244658
org study id: RhTPO-AML thrombocytopenia
nct id: NCT02244658
lead sponsor: 
has dmc: Yes
Chemotherapy-related myelosuppression usually occurs in AML patients, which induces severe
      thrombocytopenia and haemorrhage, a leading cause of death. This clinical trial aims at
      evaluating efficacy and safety of rhTPO in management of chemotherapy-induced
      thrombocytopenia in acute myelocytic leukemia.
The investigators are undertaking a parallel group, multicentre, randomized controlled trial
      of 80 adults with chemotherapy-induced thrombocytopenia from 8 medical centers in China. AML
      patients with PLT count <30×10^9/L during the previous cycle of chemotherapy are randomized
      into two groups that one receives rhTPO at 1.0μg/kg·d subcutaneously for 7~14 consecutive
      days and the other receives no rhTPO or other thrombopoietic factor. Platelet count, bleeding
      and other symptoms were evaluated before and after treatment. Adverse events are also
      recorded throughout the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of platelet response
time frame: 21 days since the first administration
description: days that PLT count rebound to 30×10^9/L, 50×10^9/L and 100×10^9/L, respectively, from the minimal level after the very cycle of chemotherapy.
arm group label: rhTPO
arm group type: Experimental
description: rhTPO 1.0 μg/kg·d subcutaneously for 7~14 consecutive days
arm group label: control
arm group type: No Intervention
description: no thrombopoietic agents
intervention type: Drug
intervention name: rhTPO
description: rhTPO 1.0 μg/kg·d subcutaneously for 7~14 consecutive days
arm group label: rhTPO
other name: TPIAO
other name: S20050048/49 (SFDA, China)
criteria: 
gender: All
minimum age: 15 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ming Hou
email: houming@medmail.com.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Ming Hou
investigator title: Professor and Director
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Thrombocytopenia