<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/NCT03010579</url>
  </required_header>
  <id_info>
    <org_study_id>PKU-2016KT64</org_study_id>
    <nct_id>NCT03010579</nct_id>
  </id_info>
  <brief_title>Erythropoietin in the Treatment of Anemia After Autologous Hematopoietic Stem Cell Transplantation</brief_title>
  <official_title>Efficacy and Safety of Erythropoietin in the Treatment of Anemia in Patients With Lymphoma After Autologous Hematopoietic Stem Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an randomized trial to evaluate the potential benefit of erythropoietin in the&#xD;
      treatment of anemia in patients with lymphoma after autologous hematopoietic stem cell&#xD;
      transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lymphoma patients with anemia on day +15 post-transplant will be randomized to erythropoietin&#xD;
      group or control group. Potential benefit of erythropoietin will be evaluatedon day +60&#xD;
      post-transplant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 4</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>complete hemoglobin response rate</measure>
    <time_frame>from day +15 to day +60 after autologous hematopoietic stem cell transplantation</time_frame>
    <description>proportion of complete correctors (reaching hemoglobin 120 g/L in male patients, 110 g/L in female patients) before day +60 post-transplant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>proportion of participants with red blood cell transfusions</measure>
    <time_frame>from day +15 to day +60 after autologous hematopoietic stem cell transplantation</time_frame>
    <description>proportion of participants with red blood cell transfusions from day +15 to day +60 post-transplant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of participants with deep vein thrombosis</measure>
    <time_frame>from day +15 to day +60 after autologous hematopoietic stem cell transplantation</time_frame>
    <description>proportion of participants with deep vein thrombosis from day +15 to day +60 post-transplant</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Anemia</condition>
  <condition>Lymphoma</condition>
  <condition>Hematopoietic Stem Cell Transplantation</condition>
  <arm_group>
    <arm_group_label>erythropoietin group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For those lymphoma patients with hemoglobin level less than 100 g/L on day +15 after autologous hematopoietic stem cell transplantation, erythropoietin will be administered. If necessary,oral ferrous succinate vitamins B12 and folic acid will be administered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>iron supplementation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>If necessary，oral ferrous succinate, vitamins B12 and folic acid will be administered.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>erythropoietin</intervention_name>
    <description>Erythropoietin will be administered subcutaneously (s.c.) at the dose of 10 000 IU, three times a week. If necessary,oral ferrous succinate vitamins B12 and folic acid will be administered.</description>
    <arm_group_label>erythropoietin group</arm_group_label>
    <other_name>Erythropoiesis-Stimulating Agent</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>iron supplementation</intervention_name>
    <description>If necessary, oral ferrous succinate, vitamins B12 and folic acid will be administered.</description>
    <arm_group_label>iron supplementation</arm_group_label>
    <other_name>ferrous succinate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  confirmed lymphoma&#xD;
&#xD;
          -  first autologous hematopoietic stem cell transplantation&#xD;
&#xD;
          -  hemoglobin level less than 100 g/L on day +15 post-transplant&#xD;
&#xD;
          -  written informed consent given by patient or his/her guardian if of minor age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  HIV positive&#xD;
&#xD;
          -  Known allergy to recombinant human erythropoietin&#xD;
&#xD;
          -  Uncontrolled infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking University Cancer Hospital &amp; Institute</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wei Ping Liu</last_name>
      <email>dreaming2217@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Xiao Pei Wang</last_name>
      <email>cadillac570@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 3, 2017</last_update_submitted>
  <last_update_submitted_qc>January 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Jun Zhu</investigator_full_name>
    <investigator_title>Chairman of Lymphoma Department</investigator_title>
  </responsible_party>
  <keyword>Anemia</keyword>
  <keyword>Lymphoma</keyword>
  <keyword>Hematopoietic stem cell transplantation</keyword>
  <keyword>Erythropoietin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Anemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epoetin Alfa</mesh_term>
    <mesh_term>Ferrous succinate</mesh_term>
    <mesh_term>Hematinics</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/NCT03010579
org study id: PKU-2016KT64
nct id: NCT03010579
lead sponsor: 
has dmc: No
This is an randomized trial to evaluate the potential benefit of erythropoietin in the
      treatment of anemia in patients with lymphoma after autologous hematopoietic stem cell
      transplantation.
Lymphoma patients with anemia on day +15 post-transplant will be randomized to erythropoietin
      group or control group. Potential benefit of erythropoietin will be evaluatedon day +60
      post-transplant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: complete hemoglobin response rate
time frame: from day +15 to day +60 after autologous hematopoietic stem cell transplantation
description: proportion of complete correctors (reaching hemoglobin 120 g/L in male patients, 110 g/L in female patients) before day +60 post-transplant
measure: proportion of participants with red blood cell transfusions
time frame: from day +15 to day +60 after autologous hematopoietic stem cell transplantation
description: proportion of participants with red blood cell transfusions from day +15 to day +60 post-transplant
measure: proportion of participants with deep vein thrombosis
time frame: from day +15 to day +60 after autologous hematopoietic stem cell transplantation
description: proportion of participants with deep vein thrombosis from day +15 to day +60 post-transplant
arm group label: erythropoietin group
arm group type: Experimental
description: For those lymphoma patients with hemoglobin level less than 100 g/L on day +15 after autologous hematopoietic stem cell transplantation, erythropoietin will be administered. If necessary,oral ferrous succinate vitamins B12 and folic acid will be administered.
arm group label: iron supplementation
arm group type: Active Comparator
description: If necessary，oral ferrous succinate, vitamins B12 and folic acid will be administered.
intervention type: Drug
intervention name: erythropoietin
description: Erythropoietin will be administered subcutaneously (s.c.) at the dose of 10 000 IU, three times a week. If necessary,oral ferrous succinate vitamins B12 and folic acid will be administered.
arm group label: erythropoietin group
other name: Erythropoiesis-Stimulating Agent
intervention type: Drug
intervention name: iron supplementation
description: If necessary, oral ferrous succinate, vitamins B12 and folic acid will be administered.
arm group label: iron supplementation
other name: ferrous succinate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Jun Zhu
investigator title: Chairman of Lymphoma Department
mesh term: Lymphoma
mesh term: Anemia
mesh term: Epoetin Alfa
mesh term: Ferrous succinate
mesh term: Hematinics
sharing ipd: No