<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/NCT04497688</url>
  </required_header>
  <id_info>
    <org_study_id>CSPC -JYL-NHL-03</org_study_id>
    <nct_id>NCT04497688</nct_id>
  </id_info>
  <brief_title>Evaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma</brief_title>
  <official_title>A Multi-center, Open-label, Single-arm Study to Evaluate the Efficacy and Safety of PEG-rhG-CSF(Jinyouli®) in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hebei Medical University Fourth 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>
      The main treatments for non-Hodgkin's lymphoma are surgery, radiotherapy, chemotherapy, and&#xD;
      bone marrow transplantation. Neutropenia is the most common and serious complication of most&#xD;
      chemotherapy. This study is a multi-center, open-label, single-arm clinical study to evaluate&#xD;
      the efficacy and safety of jinyouli in preventing neutropenia in patients with non Hodgkin's&#xD;
      lymphoma after chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">October 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of grade Ⅲ/Ⅳ neutropenia</measure>
    <time_frame>From date of randomization until the date of the study completion，up to 24 weeks</time_frame>
    <description>Grade Ⅲ neutropenia is defined as ANC≥0.5×10^9/L, and &lt;1×10^9/L; Grade Ⅳ neutropenia is defined as ANC&lt;0.5×10^9/L</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of febrile neutropenia (FN)</measure>
    <time_frame>From date of randomization until the date of the study completion，up to 24 weeks</time_frame>
    <description>A single oral temperature is 38.3℃ or ≥38℃ for more than 1 h, and the absolute value of neutrophils is less than 0.5×10^9/L or the absolute value of neutrophils is less than 1.0×10^9/L but it is expected to drop to less than 0.5×10^9/L within 48 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibiotic use rate</measure>
    <time_frame>From date of randomization until the date of the study completion，up to 24 weeks</time_frame>
    <description>Antibiotic use rate during the treatment cycle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of dose adjustment of chemotherapy or delay of chemotherapy</measure>
    <time_frame>From date of randomization until the date of the study completion，up to 24 weeks</time_frame>
    <description>Dose adjustment is defined as the reduction of planned dose of chemotherapy; Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">104</enrollment>
  <condition>Non Hodgkin's Lymphoma</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®) 48 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>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PEG-rhG-CSF</intervention_name>
    <description>Patients received a single dose of PEG-rhG-CSF per cycle. The chemotherapy regimen must meet the interval between two chemotherapy sessions at least 12 days.</description>
    <arm_group_label>PEG-rhG-CSF group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years, gender is not limited;&#xD;
&#xD;
          2. Patients with lymphoma diagnosed by histopathology or cytology;&#xD;
&#xD;
          3. Patients requiring multi-cycle chemotherapy;&#xD;
&#xD;
          4. Planned chemotherapy regimen FN risk ≥ 20 % , or 10% &lt;FN risk &lt; 20% with high risk&#xD;
             factors ; According to the judgment of the investigator, there is a risk of FN&#xD;
             occurrence if G-CSF support is not accepted, PEG-rhG-CSF should be used&#xD;
             prophylactically from the first cycle;&#xD;
&#xD;
          5. Physical status (KPS) score ≥ 70 points;&#xD;
&#xD;
          6. Expected Survival period of more than 3 months;&#xD;
&#xD;
          7. Normal bone marrow hematopoietic function (ANC ≥1.5×10^9/L, PLT≥80×10^9/L, Hb≥75g/L,&#xD;
             WBC≥3.0×10^9/L);&#xD;
&#xD;
          8. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 times the&#xD;
             upper limit of normal value, or≤5 times the upper limit of normal value when there is&#xD;
             liver metastasis; total bilirubin (TBIL)≤2.5 times the upper limit of normal value;&#xD;
             serum creatinine (Cr)≤2 times the upper limit of normal value;&#xD;
&#xD;
          9. Female patients of childbearing age must be negative in urine pregnancy test before&#xD;
             treatment;&#xD;
&#xD;
         10. The testers (or their legal representatives/guardians) must sign an informed consent&#xD;
             form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lymphoma central involvement;&#xD;
&#xD;
          2. Hematopoietic stem cell transplantation or organ transplantation;&#xD;
&#xD;
          3. Local or systemic infection without adequate control;&#xD;
&#xD;
          4. Severe internal organ dysfunction and occurred in the last 6 months Myocardial&#xD;
             infarction;&#xD;
&#xD;
          5. Those who used other test drugs of the same kind or accepted other clinical trials&#xD;
             within 4 weeks before enrollmen；&#xD;
&#xD;
          6. Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by&#xD;
             Escherichia coli;&#xD;
&#xD;
          7. Severe mental illness, affecting informed consent and/or adverse reaction expression&#xD;
             or observation;&#xD;
&#xD;
          8. Pregnant or lactating female patients; women who refuse to accept contraceptive&#xD;
             measures ;&#xD;
&#xD;
          9. Researchers determine unsuited to participate in this trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lihong Liu, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Fourth Hospital of Hebei Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lihong Liu, PHD</last_name>
    <phone>86-13831177920</phone>
    <email>13831177920@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The fourth hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050019</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lihong Liu, PHD</last_name>
      <phone>86-13831177920</phone>
      <email>13831177920@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 2, 2020</last_update_submitted>
  <last_update_submitted_qc>August 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 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>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Neutropenia</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/NCT04497688
org study id: CSPC -JYL-NHL-03
nct id: NCT04497688
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The main treatments for non-Hodgkin's lymphoma are surgery, radiotherapy, chemotherapy, and
      bone marrow transplantation. Neutropenia is the most common and serious complication of most
      chemotherapy. This study is a multi-center, open-label, single-arm clinical study to evaluate
      the efficacy and safety of jinyouli in preventing neutropenia in patients with non Hodgkin's
      lymphoma after chemotherapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The incidence of grade Ⅲ/Ⅳ neutropenia
time frame: From date of randomization until the date of the study completion，up to 24 weeks
description: Grade Ⅲ neutropenia is defined as ANC≥0.5×10^9/L, and <1×10^9/L; Grade Ⅳ neutropenia is defined as ANC<0.5×10^9/L
measure: Incidence of febrile neutropenia (FN)
time frame: From date of randomization until the date of the study completion，up to 24 weeks
description: A single oral temperature is 38.3℃ or ≥38℃ for more than 1 h, and the absolute value of neutrophils is less than 0.5×10^9/L or the absolute value of neutrophils is less than 1.0×10^9/L but it is expected to drop to less than 0.5×10^9/L within 48 hours
measure: Antibiotic use rate
time frame: From date of randomization until the date of the study completion，up to 24 weeks
description: Antibiotic use rate during the treatment cycle
measure: Incidence of dose adjustment of chemotherapy or delay of chemotherapy
time frame: From date of randomization until the date of the study completion，up to 24 weeks
description: Dose adjustment is defined as the reduction of planned dose of chemotherapy; Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days.
arm group label: PEG-rhG-CSF group
arm group type: Experimental
description: Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®) 48 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
intervention type: Drug
intervention name: PEG-rhG-CSF
description: Patients received a single dose of PEG-rhG-CSF per cycle. The chemotherapy regimen must meet the interval between two chemotherapy sessions at least 12 days.
arm group label: PEG-rhG-CSF group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lihong Liu, PHD
role: Principal Investigator
affiliation: The Fourth Hospital of Hebei Medical University
last name: Lihong Liu, PHD
phone: 86-13831177920
email: 13831177920@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Neutropenia