<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/NCT04497701</url>
  </required_header>
  <id_info>
    <org_study_id>CSPC-JYL-CHIL-01</org_study_id>
    <nct_id>NCT04497701</nct_id>
  </id_info>
  <brief_title>Evaluate the Efficacy and Safety of the Prophylactic Use of PEG-rhG-CSF in Children With Hematological Malignancies</brief_title>
  <official_title>A Multi-center, Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of the Prophylactic Use of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor After Chemotherapy in Children With Hematological Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital of Fudan University</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 incidence of infectious complications in hematological malignancies is higher than that&#xD;
      in children with solid tumors, which may be related to the type and dose intensity of&#xD;
      chemotherapy regimens used in hematological tumors. The treatment of childhood cancer has&#xD;
      changed in the past few decades: intensive treatment and good supportive treatment can&#xD;
      improve the 5-year survival rate of children. The aim of this study was to evaluate the&#xD;
      efficacy and safety of prophylactic use of pegylated recombinant human granulocyte&#xD;
      colony-stimulating factor (PEG-rhG-CSF) after chemotherapy in children with hematological&#xD;
      malignancies.&#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">December 1, 2021</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_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>ANC&lt;0.5×10^9/L or ANC (0.5-0.9)×10^9/L, and predicted to drop to ≤0.5×10^9/L in the next 48 hours, and the oral cavity temperature is ≥38.3℃ or ≥38.0℃ for more than 1 hour.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of febrile neutropenia</measure>
    <time_frame>From date of randomization until the date of the study completion, up to 24 weeks.</time_frame>
    <description>Defined as days when the FN occurs to the time when FN disappears.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and duration of grade IV neutropenia (ANC&lt;0.5×10^9/L)</measure>
    <time_frame>From date of randomization until the date of the study completion, up to 24 weeks.</time_frame>
    <description>Grade IV neutropenia is defined as the absolute neutrophil count(ANC)&lt;0.5×10^9/L; Duration of grade IV neutropenia is 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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery time of grade IV neutropenia</measure>
    <time_frame>From date of randomization until the date of the study completion, up to 24 weeks.</time_frame>
    <description>Time from the first day of chemotherapy to ANC≥0.5×10^9/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic curve of absolute neutrophil count (ANC)</measure>
    <time_frame>From date of randomization until the date of the study completion, up to 24 weeks.</time_frame>
    <description>Dynamic changes of ANC after chemotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>From date of randomization until the date of the study completion, up to 24 weeks.</time_frame>
    <description>Number of days the patient was hospitalized</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of infection</measure>
    <time_frame>From date of randomization until the date of the study completion, up to 24 weeks.</time_frame>
    <description>Incidence of various infections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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 of chemotherapy is defined as incidence of 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>2</number_of_arms>
  <enrollment type="Anticipated">139</enrollment>
  <condition>Lymphoma</condition>
  <condition>Leukemia</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®)24~72 hours after the end of chemotherapy, 100µg/kg, once in each 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 24~72 hours after the end of chemotherapy, 100µg/kg/d, and stop using it until the ANC value exceeds the lowest value for 2 consecutive days&gt; 0.5×10^9/L.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PEG-rhG-CSF group</intervention_name>
    <description>Patients received a single dose of 100 ug/kg of PEG-rhG-CSF（Jinyouli®）, on the basis of actual body weight. Peg-rhG-CSF can be used prophylactically only when the interval between two chemotherapy regimens is no less than 12 days.</description>
    <arm_group_label>PEG-rhG-CSF group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rhG-CSF group</intervention_name>
    <description>Patients received 5μg/kg/d of rhG-CSF, on the basis of actual body weight.</description>
    <arm_group_label>rhG-CSF group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Under the age of 18, no gender limit;&#xD;
&#xD;
          2. Children with hematological malignancies, leukemia or lymphoma, diagnosed by bone&#xD;
             marrow pathology or cytology;&#xD;
&#xD;
          3. The prophylactic use of PEG-rhG-CSF or rhG-CSF after chemotherapy is intended to&#xD;
             prevent neutropenia, and the chemotherapy regimen must meet the interval between two&#xD;
             chemotherapy sessions at least 12 days;&#xD;
&#xD;
          4. The effect of chemotherapy in leukemia patients was complete remission, while that in&#xD;
             lymphoma patients was complete remission or partial remission;&#xD;
&#xD;
          5. The expected survival time is more than 8 months;&#xD;
&#xD;
          6. Liver and kidney function: Liver function: total bilirubin (TBIL), alanine&#xD;
             aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit&#xD;
             of normal value, or≤5 times the upper limit of normal value when there is liver&#xD;
             metastasis; renal function test: serum creatinine (Cr) ≤ 1.5 times the upper limit of&#xD;
             normal value;&#xD;
&#xD;
          7. Eastern Cooperative Oncology Group(ECOG) performance status(PS) &lt;2;&#xD;
&#xD;
          8. The subjects had good mental consciousness, and the subject's legal guardian must sign&#xD;
             an informed consent form;&#xD;
&#xD;
          9. Researchers believe that the subject can benefit;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe internal organ dysfunction;&#xD;
&#xD;
          2. Those who used other test drugs of the same kind or accepted other clinical trials&#xD;
             within 4 weeks before enrollment;&#xD;
&#xD;
          3. Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by&#xD;
             Escherichia coli;&#xD;
&#xD;
          4. Researchers determine unsuited to participate in this trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaowen Zhai, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaowen Zhai, Doctor</last_name>
    <phone>86-18017590808</phone>
    <email>zhaixiaowendy@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Children's Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Xiaowen Zhai, Doctor</last_name>
      <phone>86-18017590808</phone>
      <email>zhaixiaowendy@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>Hematologic Neoplasms</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/NCT04497701
org study id: CSPC-JYL-CHIL-01
nct id: NCT04497701
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The incidence of infectious complications in hematological malignancies is higher than that
      in children with solid tumors, which may be related to the type and dose intensity of
      chemotherapy regimens used in hematological tumors. The treatment of childhood cancer has
      changed in the past few decades: intensive treatment and good supportive treatment can
      improve the 5-year survival rate of children. The aim of this study was to evaluate the
      efficacy and safety of prophylactic use of pegylated recombinant human granulocyte
      colony-stimulating factor (PEG-rhG-CSF) after chemotherapy in children with hematological
      malignancies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of febrile neutropenia (FN)
time frame: From date of randomization until the date of the study completion, up to 24 weeks.
description: ANC<0.5×10^9/L or ANC (0.5-0.9)×10^9/L, and predicted to drop to ≤0.5×10^9/L in the next 48 hours, and the oral cavity temperature is ≥38.3℃ or ≥38.0℃ for more than 1 hour.
measure: Duration of febrile neutropenia
time frame: From date of randomization until the date of the study completion, up to 24 weeks.
description: Defined as days when the FN occurs to the time when FN disappears.
measure: Incidence and duration of grade IV neutropenia (ANC<0.5×10^9/L)
time frame: From date of randomization until the date of the study completion, up to 24 weeks.
description: Grade IV neutropenia is defined as the absolute neutrophil count(ANC)<0.5×10^9/L; Duration of grade IV neutropenia is defined as days when the ANC<0.5×10^9/L occurs to the time when the ANC≥0.5×10^9/L
measure: Recovery time of grade IV neutropenia
time frame: From date of randomization until the date of the study completion, up to 24 weeks.
description: Time from the first day of chemotherapy to ANC≥0.5×10^9/L
measure: Dynamic curve of absolute neutrophil count (ANC)
time frame: From date of randomization until the date of the study completion, up to 24 weeks.
description: Dynamic changes of ANC after chemotherapy
measure: Hospital stay
time frame: From date of randomization until the date of the study completion, up to 24 weeks.
description: Number of days the patient was hospitalized
measure: Incidence of infection
time frame: From date of randomization until the date of the study completion, up to 24 weeks.
description: Incidence of various infections
measure: 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 of chemotherapy is defined as incidence of 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®)24~72 hours after the end of chemotherapy, 100µg/kg, once in each chemotherapy cycle.
arm group label: rhG-CSF group
arm group type: Active Comparator
description: Patients received subcutaneous injection of rhG-CSF 24~72 hours after the end of chemotherapy, 100µg/kg/d, and stop using it until the ANC value exceeds the lowest value for 2 consecutive days> 0.5×10^9/L.
intervention type: Drug
intervention name: PEG-rhG-CSF group
description: Patients received a single dose of 100 ug/kg of PEG-rhG-CSF（Jinyouli®）, on the basis of actual body weight. Peg-rhG-CSF can be used prophylactically only when the interval between two chemotherapy regimens is no less than 12 days.
arm group label: PEG-rhG-CSF group
intervention type: Drug
intervention name: rhG-CSF group
description: Patients received 5μg/kg/d of rhG-CSF, on the basis of actual body weight.
arm group label: rhG-CSF group
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Xiaowen Zhai, Doctor
role: Principal Investigator
affiliation: Children's Hospital of Fudan University
last name: Xiaowen Zhai, Doctor
phone: 86-18017590808
email: zhaixiaowendy@163.com
facility: 
contact: 
country: China
responsible party type: Sponsor
mesh term: Hematologic Neoplasms