xml: <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/NCT06026995</url>
    </required_header>
    <id_info>
      <org_study_id>CSPC-JYL-PBSCT-02</org_study_id>
      <nct_id>NCT06026995</nct_id>
    </id_info>
    <brief_title>Clinical Study on PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells</brief_title>
    <official_title>Clinical Study on the Effectiveness and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells for Lymphoma and Multiple Myeloma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chongqing University Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Chongqing University Cancer Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a randomized controlled, open and multi-center clinical study. Patients who&#xD;
        meet the selection criteria and do not meet the exclusion criteria are randomly given&#xD;
        PEG-rhG-CSF with a fixed dose of 12mg when white blood cells reach the lowest point, or given&#xD;
        rhG-CSF with a daily mobilization of 5-10μ g/kg until the collection is completed, so as to&#xD;
        evaluate the effectiveness and safety of PEG-rhG-CSF in mobilizing autologous stem cells for&#xD;
        lymphoma and multiple myeloma.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2022</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</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>The proportion of patients with CD34+ cells ≥2×106/kg</measure>
      <time_frame>28 days</time_frame>
      <description>The proportion of patients with CD34+ cells ≥2×106/kg</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>CD34+cell count</measure>
      <time_frame>28 days</time_frame>
      <description>CD34+cell count</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acquisition times</measure>
      <time_frame>28 days</time_frame>
      <description>The number of times a patient needs to collect a sufficient number of CD34+ cells</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mobilization time</measure>
      <time_frame>28 days</time_frame>
      <description>Time interval from mobilization to collection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hematopoietic reconstruction time after transplantation</measure>
      <time_frame>3 months</time_frame>
      <description>Hematopoietic reconstruction time after transplantation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>complication</measure>
      <time_frame>3 months</time_frame>
      <description>complication</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">174</enrollment>
    <condition>Lymphoma</condition>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>PEG-rhG-CSF</intervention_name>
      <description>Subcutaneous injection with a fixed dose of 12 mg</description>
      <arm_group_label>experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>RhG-CSF</intervention_name>
      <description>Inject rhG-CSF 5-10 μg/kg subcutaneously every day</description>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 18-65 years old, regardless of sex;&#xD;
  &#xD;
            2. Patients with lymphoma and multiple myeloma who need autologous hematopoietic stem&#xD;
               cell transplantation;&#xD;
  &#xD;
            3. KPS score ≥70;&#xD;
  &#xD;
            4. creatinine clearance rate ≥ 50mL/min, total bilirubin level &lt; 1.5mg/dL, ALT and AST &lt;&#xD;
               2 times the upper limit of normal value;&#xD;
  &#xD;
            5. Absolute neutrophil count (ANC)≥1.5×109/L, platelet count ≥80×109/L, Hb≥ 75g/L, WBC ≥&#xD;
               3.0× 109/L;&#xD;
  &#xD;
            6. Patients can tolerate chemotherapy;&#xD;
  &#xD;
            7. No active infection before chemotherapy;&#xD;
  &#xD;
            8. The patient voluntarily participated in this trial and signed the informed consent&#xD;
               form;&#xD;
  &#xD;
            9. The researcher thinks that the subjects can benefit.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Those who have previously received allogeneic or autologous hematopoietic stem cell&#xD;
               transplantation;&#xD;
  &#xD;
            2. Serious or uncontrolled virus infection: HIV, syphilis positive;&#xD;
  &#xD;
            3. Severe dysfunction of internal organs;&#xD;
  &#xD;
            4. severe mental or nervous system diseases;&#xD;
  &#xD;
            5. allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed in&#xD;
               Escherichia coli;&#xD;
  &#xD;
            6. pregnant or lactating female patients; Women of childbearing age refuse to accept&#xD;
               contraceptive measures; Those who plan to become pregnant during the study period;&#xD;
  &#xD;
            7. The researcher judges other subjects who are not suitable to participate.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yao Liu, doctor</last_name>
      <phone>132 2868 4685</phone>
      <email>64823926@qq.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chongqing University Cancer Hospital</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <zip>400030</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yao Liu</last_name>
        <phone>13228684685</phone>
        <email>64823926@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chongqing University Cancer Hospital</investigator_affiliation>
      <investigator_full_name>Yao Liu</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026995
  org study id: CSPC-JYL-PBSCT-02
  nct id: NCT06026995
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study is a randomized controlled, open and multi-center clinical study. Patients who
        meet the selection criteria and do not meet the exclusion criteria are randomly given
        PEG-rhG-CSF with a fixed dose of 12mg when white blood cells reach the lowest point, or given
        rhG-CSF with a daily mobilization of 5-10μ g/kg until the collection is completed, so as to
        evaluate the effectiveness and safety of PEG-rhG-CSF in mobilizing autologous stem cells for
        lymphoma and multiple myeloma.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The proportion of patients with CD34+ cells ≥2×106/kg
  time frame: 28 days
  description: The proportion of patients with CD34+ cells ≥2×106/kg
  measure: CD34+cell count
  time frame: 28 days
  description: CD34+cell count
  measure: Acquisition times
  time frame: 28 days
  description: The number of times a patient needs to collect a sufficient number of CD34+ cells
  measure: Mobilization time
  time frame: 28 days
  description: Time interval from mobilization to collection
  measure: Hematopoietic reconstruction time after transplantation
  time frame: 3 months
  description: Hematopoietic reconstruction time after transplantation
  measure: complication
  time frame: 3 months
  description: complication
  arm group label: experimental group
  arm group type: Experimental
  arm group label: control group
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: PEG-rhG-CSF
  description: Subcutaneous injection with a fixed dose of 12 mg
  arm group label: experimental group
  intervention type: Drug
  intervention name: RhG-CSF
  description: Inject rhG-CSF 5-10 μg/kg subcutaneously every day
  arm group label: control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Yao Liu, doctor
  phone: 132 2868 4685
  email: 64823926@qq.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Chongqing University Cancer Hospital
  investigator full name: Yao Liu
  investigator title: Director
  mesh term: Lymphoma
  sharing ipd: No