<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/NCT04500886</url>
  </required_header>
  <id_info>
    <org_study_id>CSPC-JYL-HLH-01</org_study_id>
    <nct_id>NCT04500886</nct_id>
  </id_info>
  <brief_title>Evaluate the Efficacy and Safety of PEG-rhG-CSF in Patients With Hemophagocytic Syndrome</brief_title>
  <official_title>A Single-center, Open-label, Controlled Clinical Study to Evaluate the Efficacy and Safety of Jinyouli®(PEG-rhG-CSF) for the Recovery of Neutropenia After Chemotherapy in Patients With Hemophagocytic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hemophagocytic syndrome (HPS), also known as hemophagocytic lymphohistiocytosis (HLH), is an&#xD;
      immune mediated life-threatening disease. There is no uniform recommendation for salvage&#xD;
      treatment of HLH. Based on the results of current clinical trials, the marketing situation of&#xD;
      the drug in China, and the use requirements of pegylated recombinant human granulocyte&#xD;
      stimulating factor(PEG-rhG-CSF), this study was conducted in patients who received the DEP&#xD;
      rescue therapy or dexamethasone combined with VP-16 maintenance therapy. The aim of this&#xD;
      study was to evaluate the efficacy and safety of PEG-rhG-CSF(Jinyouli®) for the recovery of&#xD;
      neutropenia after chemotherapy in patients with hemophagocytic syndrome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of grade IV neutropenia</measure>
    <time_frame>From date of randomization until the date of the study completion，up to 1 year.</time_frame>
    <description>Defined as days when the ANC&lt;0.5×10^9/L occurs to the time when the ANC≥0.5×10^9/L.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The recovery time of neutrophils after chemotherapy</measure>
    <time_frame>From date of randomization until the date of the study completion，up to 1 year.</time_frame>
    <description>Defined as days when the ANC&lt;2.0×10^9/L occurs to the time when the ANC≥2.0×10^9/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neutrophil dynamic changes</measure>
    <time_frame>From date of randomization until the date of the study completion，up to 1 year.</time_frame>
    <description>The dynamic changes of neutrophil count were observed after chemotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy evaluation of salvage therapy</measure>
    <time_frame>From date of randomization until the date of the study completion，up to 1 year.</time_frame>
    <description>Complete response (CR) and partial response (PR) rates.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Hemophagocytic Syndrome</condition>
  <arm_group>
    <arm_group_label>PEG-rhG-CSF group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®)24 hours after the end of chemotherapy, 6mg for patients with body weight ≥ 45kg and 3mg for patients with body weight less than 45kg, once per chemotherapy cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>rhG-CSF group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients received subcutaneous injection of rhG-CSF 24 hours after the end of chemotherapy, 300ug for patients with body weight ≥45kg and 150ug for patients with body weight less than 45kg, Once a day for 3-5 days until the absolute count of neutrophils ≥2×109/L.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PEG-rhG-CSF</intervention_name>
    <description>PEG-rhG-CSF is a sustained-duration form of rhG-CSF, a recombinant methionyl form of human granulocyte colony-stimulating factor (G-CSF), similar to rhG-CSF, PEG-rhG-CSF increases the proliferation and differentiation of neutrophils from committed progenitor cells, induces maturation, and enhances the survival and function of mature neutrophils, resulting in dose-dependent increases in neutrophils.</description>
    <arm_group_label>PEG-rhG-CSF group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rhG-CSF</intervention_name>
    <description>rhG-CSF can increase the proliferation and differentiation of neutrophils from committed progenitor cells, induces maturation, and enhances the survival and function of mature neutrophils.</description>
    <arm_group_label>rhG-CSF group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria：&#xD;
&#xD;
          1. Age ≥ 18 years old, ≤ 70 years old;&#xD;
&#xD;
          2. Patients with hemophagocytic syndrome diagnosed by HLH-2004 diagnostic criteria;&#xD;
&#xD;
          3. Patients who plan to receive rescue treatment or maintenance treatment;&#xD;
&#xD;
          4. The expected survival time is more than 1 month;&#xD;
&#xD;
          5. Patients sign informed consent form.&#xD;
&#xD;
        Exclusion Criteria：&#xD;
&#xD;
          1. Patients who have received bone marrow or hematopoietic stem cell transplantation in&#xD;
             the past 3 months;&#xD;
&#xD;
          2. Patients with brain metastases;&#xD;
&#xD;
          3. Patients who are allergic to this product or other biological products derived from&#xD;
             genetic engineering E. coli;&#xD;
&#xD;
          4. People with mental or nervous system disorders who cannot cooperate;&#xD;
&#xD;
          5. Pregnant or lactating female patients; women who refuse to accept contraceptive&#xD;
             measures ;&#xD;
&#xD;
          6. Researchers determine unsuited to participate in this trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhao Wang, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Friendship Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhao Wang, PHD</last_name>
    <phone>86-1063139862</phone>
    <email>catenny@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Friendship Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Zhao Wang, PHD</last_name>
      <phone>86-1063139862</phone>
      <email>catenny@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</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>Lymphohistiocytosis, Hemophagocytic</mesh_term>
    <mesh_term>Syndrome</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/NCT04500886
org study id: CSPC-JYL-HLH-01
nct id: NCT04500886
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Hemophagocytic syndrome (HPS), also known as hemophagocytic lymphohistiocytosis (HLH), is an
      immune mediated life-threatening disease. There is no uniform recommendation for salvage
      treatment of HLH. Based on the results of current clinical trials, the marketing situation of
      the drug in China, and the use requirements of pegylated recombinant human granulocyte
      stimulating factor(PEG-rhG-CSF), this study was conducted in patients who received the DEP
      rescue therapy or dexamethasone combined with VP-16 maintenance therapy. The aim of this
      study was to evaluate the efficacy and safety of PEG-rhG-CSF(Jinyouli®) for the recovery of
      neutropenia after chemotherapy in patients with hemophagocytic syndrome.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Duration of grade IV neutropenia
time frame: From date of randomization until the date of the study completion，up to 1 year.
description: Defined as days when the ANC<0.5×10^9/L occurs to the time when the ANC≥0.5×10^9/L.
measure: The recovery time of neutrophils after chemotherapy
time frame: From date of randomization until the date of the study completion，up to 1 year.
description: Defined as days when the ANC<2.0×10^9/L occurs to the time when the ANC≥2.0×10^9/L.
measure: Neutrophil dynamic changes
time frame: From date of randomization until the date of the study completion，up to 1 year.
description: The dynamic changes of neutrophil count were observed after chemotherapy.
measure: Efficacy evaluation of salvage therapy
time frame: From date of randomization until the date of the study completion，up to 1 year.
description: Complete response (CR) and partial response (PR) rates.
arm group label: PEG-rhG-CSF group
arm group type: Experimental
description: Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®)24 hours after the end of chemotherapy, 6mg for patients with body weight ≥ 45kg and 3mg for patients with body weight less than 45kg, once per chemotherapy cycle
arm group label: rhG-CSF group
arm group type: Active Comparator
description: Patients received subcutaneous injection of rhG-CSF 24 hours after the end of chemotherapy, 300ug for patients with body weight ≥45kg and 150ug for patients with body weight less than 45kg, Once a day for 3-5 days until the absolute count of neutrophils ≥2×109/L.
intervention type: Drug
intervention name: PEG-rhG-CSF
description: PEG-rhG-CSF is a sustained-duration form of rhG-CSF, a recombinant methionyl form of human granulocyte colony-stimulating factor (G-CSF), similar to rhG-CSF, PEG-rhG-CSF increases the proliferation and differentiation of neutrophils from committed progenitor cells, induces maturation, and enhances the survival and function of mature neutrophils, resulting in dose-dependent increases in neutrophils.
arm group label: PEG-rhG-CSF group
intervention type: Drug
intervention name: rhG-CSF
description: rhG-CSF can increase the proliferation and differentiation of neutrophils from committed progenitor cells, induces maturation, and enhances the survival and function of mature neutrophils.
arm group label: rhG-CSF group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Zhao Wang, PHD
role: Principal Investigator
affiliation: Beijing Friendship Hospital
last name: Zhao Wang, PHD
phone: 86-1063139862
email: catenny@hotmail.com
facility: 
contact: 
country: China
responsible party type: Sponsor
mesh term: Lymphohistiocytosis, Hemophagocytic
mesh term: Syndrome