<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/NCT04460508</url>
  </required_header>
  <id_info>
    <org_study_id>mecapegfilgrastim-lym-2020-1</org_study_id>
    <nct_id>NCT04460508</nct_id>
  </id_info>
  <brief_title>Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma</brief_title>
  <official_title>Efficacy and Safety of Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma: a Randomized, Open-label, Active-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Hospital of Jilin University</source>
  <oversight_info>
    <has_dmc>No</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>
      Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor&#xD;
      to limit the dosage and the continuation of chemotherapy.A newly pegylated rhG-CSF was&#xD;
      independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2&#xD;
      trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma&#xD;
      half-life, and prolonged efficacy in compare with ﬁlgrastim.&#xD;
&#xD;
      This study is to evaluate efficacy and safety in chemotherapy-induced neutropenia of&#xD;
      once-per-cycle Mecapegfilgrastim Injection(PEG-G-CSF) and daily G-CSF in Patients with&#xD;
      lymphoma patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, controlled study. A total of 170 lymphoma patients who are eligible are&#xD;
      planned to randomized assigned into two groups to receive mecapegfilgrastim fixed dose of 6&#xD;
      mg or filgrastim 5 µg/kg/day during chemotherapy.&#xD;
&#xD;
      The primary endpoint is the duration of grade ≥3 neutropenia in cycle 1. The secondary&#xD;
      endpoints include incidence of grade ≥3 neutropenia and febrile neutropenia (FN) in cycle&#xD;
      1-4, The pharmacoeconomics and safety profile are also evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 20, 2020</start_date>
  <completion_date type="Anticipated">March 20, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 20, 2022</primary_completion_date>
  <phase>Phase 2</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>Duration of grade ≥3 neutropenia in cycle 1</measure>
    <time_frame>21 days</time_frame>
    <description>Duration of subjects developing ANC lower than 1.0 × 109/L</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of grade ≥3 neutropenia in cycle 1-4</measure>
    <time_frame>84 days</time_frame>
    <description>Proportion of subjects developing ANC lower than 1.0 × 109/L from cycle 1 to cycle 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidenc of febrile neutropenia (FN) in cycle 1-4</measure>
    <time_frame>84 days</time_frame>
    <description>Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius from cycle 1 to cycle 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (AEs)</measure>
    <time_frame>84 days</time_frame>
    <description>Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Chemotherapy-induced Neutropenia</condition>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>Mecapegfilgrastim</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>rhG-CSF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pegylated rhG-CSF</intervention_name>
    <description>Pegylated rhG-CSF:6mg</description>
    <arm_group_label>Mecapegfilgrastim</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rhG-CSF</intervention_name>
    <description>rhG-CSF:5ug/kg/d</description>
    <arm_group_label>rhG-CSF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 to 75 years;&#xD;
&#xD;
          2. Patients with primary malignant lymphoma confirmed by histopathology or&#xD;
             immunomolecular biology and requiring treatment with multi-cycle high-intensity&#xD;
             chemotherapy regimen;&#xD;
&#xD;
          3. ECOG performance status ≤ 1;&#xD;
&#xD;
          4. ANC ≥1.5×109/L, PLT≥80×109 /L, Hb≥ 75g/L, WBC ≥3.0×109/L;&#xD;
&#xD;
          5. Subjects with pregnancy ability must agree to use reliable contraceptive measures from&#xD;
             screening to 1 year after treatment;&#xD;
&#xD;
          6. Patients must sign informed consent and be willing and able to comply with the&#xD;
             requirements of visits, treatment, laboratory tests and other research requirements&#xD;
             stipulated in the research schedul.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lymphoma central involvement;&#xD;
&#xD;
          2. Recipients of hematopoietic stem cell transplantation or organ transplantation;&#xD;
&#xD;
          3. Currently conducting clinical trials of other drugs;&#xD;
&#xD;
          4. There is an uncontrollable infection with body temperature ≥38℃;&#xD;
&#xD;
          5. liver function examination: total bilirubin (TBIL., alanine aminotransferase (ALT. and&#xD;
             ascetic aminotransferase (AST. were all 2.5 times the upper limit of the normal value&#xD;
             of &gt;; if they were caused by liver metastasis, the upper limit of the normal value of&#xD;
             &gt; was 5 times;Renal function test: serum creatinine (Cr. &gt;2 times the upper limit of&#xD;
             normal value&#xD;
&#xD;
          6. Patients with serious chronic diseases of heart, kidney, liver and other important&#xD;
             organs;&#xD;
&#xD;
          7. Patients with severe uncontrolled diabetes;&#xD;
&#xD;
          8. Pregnant or lactating female patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The First Bethune Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ou BAI, doctor</last_name>
      <phone>13039046656</phone>
      <email>oubai16@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 6, 2022</last_update_submitted>
  <last_update_submitted_qc>July 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Hospital of Jilin University</investigator_affiliation>
    <investigator_full_name>Ou Bai, MD/PHD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</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/NCT04460508
org study id: mecapegfilgrastim-lym-2020-1
nct id: NCT04460508
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor
      to limit the dosage and the continuation of chemotherapy.A newly pegylated rhG-CSF was
      independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2
      trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma
      half-life, and prolonged efficacy in compare with ﬁlgrastim.

      This study is to evaluate efficacy and safety in chemotherapy-induced neutropenia of
      once-per-cycle Mecapegfilgrastim Injection(PEG-G-CSF) and daily G-CSF in Patients with
      lymphoma patients.
This is a randomized, controlled study. A total of 170 lymphoma patients who are eligible are
      planned to randomized assigned into two groups to receive mecapegfilgrastim fixed dose of 6
      mg or filgrastim 5 µg/kg/day during chemotherapy.

      The primary endpoint is the duration of grade ≥3 neutropenia in cycle 1. The secondary
      endpoints include incidence of grade ≥3 neutropenia and febrile neutropenia (FN) in cycle
      1-4, The pharmacoeconomics and safety profile are also evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Duration of grade ≥3 neutropenia in cycle 1
time frame: 21 days
description: Duration of subjects developing ANC lower than 1.0 × 109/L
measure: Incidence of grade ≥3 neutropenia in cycle 1-4
time frame: 84 days
description: Proportion of subjects developing ANC lower than 1.0 × 109/L from cycle 1 to cycle 4
measure: Incidenc of febrile neutropenia (FN) in cycle 1-4
time frame: 84 days
description: Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius from cycle 1 to cycle 4
measure: Incidence of adverse events (AEs)
time frame: 84 days
description: Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0
arm group label: Mecapegfilgrastim
arm group type: Experimental
description: Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle.
arm group label: rhG-CSF
arm group type: Active Comparator
description: Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle.
intervention type: Drug
intervention name: Pegylated rhG-CSF
description: Pegylated rhG-CSF:6mg
arm group label: Mecapegfilgrastim
intervention type: Drug
intervention name: rhG-CSF
description: rhG-CSF:5ug/kg/d
arm group label: rhG-CSF
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Hospital of Jilin University
investigator full name: Ou Bai, MD/PHD
investigator title: Professor
mesh term: Lymphoma
mesh term: Neutropenia