<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/NCT04484506</url>
  </required_header>
  <id_info>
    <org_study_id>COEPL for NKTCL</org_study_id>
    <nct_id>NCT04484506</nct_id>
  </id_info>
  <brief_title>Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Extra-nodal NK/T Cell Lymphoma</brief_title>
  <official_title>A Prospective Phase II Study of Pegaspargase-COEP Chemotherapy Combined With Radiotherapy for Patients With Newly Diagnosed Extra-nodal NK/T-cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking University Cancer Hospital &amp; Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University International Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hebei Medical University Fourth Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jiangxi Provincial Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University</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 optimal first-line treatment for extra-nodal NK/T-cell lymphoma (ENKTL) has not been&#xD;
      well-defined. This phase II study aimed to evaluate the efficacy and safety of pegaspargase,&#xD;
      cyclophosphamide, vincristine, etoposide and prednisone (COEPL) regimen combined with&#xD;
      radiotherapy for patients with newly diagnosed ENKTL.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 20, 2011</start_date>
  <completion_date type="Anticipated">December 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete response rate</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>3-year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>3-year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>1-year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>NK/T Cell Lymphoma Nos</condition>
  <arm_group>
    <arm_group_label>Stage I/II nasal ENKTL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2-3 cycles of induction pegaspargase-COEP chemotherapy followed by concurrent chemoradiotherapy, then by 1-2 cycles of pegaspargase-COEP chemotherapy as consolidation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage III/IV or primary extra-nasal ENKTL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6-8 cycles of pegaspargase-COEP chemotherapy with or without local radiotherapy and/or consolidative autologous stem cell transplantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone</intervention_name>
    <description>Cyclophosphamide 750 mg/m2 intravenously on day 1, vincristine 1.4 mg/m2 intravenously on day1, etoposide 60mg/m2 intravenously on days 1-3; pegaspargase 2500IU/m2 intramuscularly on day 2, prednisone 100mg orally on days 1-5.</description>
    <arm_group_label>Stage I/II nasal ENKTL</arm_group_label>
    <arm_group_label>Stage III/IV or primary extra-nasal ENKTL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with confirmed pathological diagnosis of ENKTL as defined by WHO criteria&#xD;
&#xD;
          -  age 14-80 years&#xD;
&#xD;
          -  no prior chemotherapy or radiotherapy&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2&#xD;
&#xD;
          -  at least one measurable lesion&#xD;
&#xD;
          -  adequate bone marrow function (i.e. hemoglobin ≥80 g/l, absolute neutrophil count ≥&#xD;
             1.0 × 10^9/L, platelets ≥ 100 ×10^9/L), adequate renal function (i.e. serum creatinine&#xD;
             ≤177 μmol/L), adequate hepatic function (e.g. total bilirubin ≤ two times the upper&#xD;
             limit of normal, and ALT /AST ≤2.5 times the upper limit of normal)&#xD;
&#xD;
          -  expected survival of more than three months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  invasion of lymphoma to central nervous system&#xD;
&#xD;
          -  pre-existing coagulation disorder&#xD;
&#xD;
          -  other concomitant neoplasms&#xD;
&#xD;
          -  severe infection&#xD;
&#xD;
          -  positive HIV antibody&#xD;
&#xD;
          -  HBV DNA titer higher than 10^4 copies /ml in HBsAg-positive patients post antiviral&#xD;
             therapy&#xD;
&#xD;
          -  pregnant or lactating women&#xD;
&#xD;
          -  women of childbearing age unwilling to take contraceptive measures during the study&#xD;
             period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jun Zhu, Dr.</last_name>
    <phone>+86-13910333346</phone>
    <email>zhu-jun@bjcancer.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University Cancer Hospital &amp; Institute</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Zhu</last_name>
      <email>zj@bjcancer.org</email>
    </contact>
    <contact_backup>
      <last_name>Yuqin Song</last_name>
      <email>songyuqin622@sina.com</email>
    </contact_backup>
    <investigator>
      <last_name>Yuqin Song</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University Cancer Hospital &amp; Institute</investigator_affiliation>
    <investigator_full_name>Jun Zhu</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
    <mesh_term>Lymphoma, Extranodal NK-T-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Etoposide</mesh_term>
    <mesh_term>Vincristine</mesh_term>
    <mesh_term>Pegaspargase</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04484506
org study id: COEPL for NKTCL
nct id: NCT04484506
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The optimal first-line treatment for extra-nodal NK/T-cell lymphoma (ENKTL) has not been
      well-defined. This phase II study aimed to evaluate the efficacy and safety of pegaspargase,
      cyclophosphamide, vincristine, etoposide and prednisone (COEPL) regimen combined with
      radiotherapy for patients with newly diagnosed ENKTL.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete response rate
time frame: 1 year
measure: Overall response rate
time frame: 1 year
measure: Progression-free survival
time frame: 3-year
measure: Overall survival
time frame: 3-year
measure: Adverse events
time frame: 1-year
arm group label: Stage I/II nasal ENKTL
arm group type: Experimental
description: 2-3 cycles of induction pegaspargase-COEP chemotherapy followed by concurrent chemoradiotherapy, then by 1-2 cycles of pegaspargase-COEP chemotherapy as consolidation
arm group label: Stage III/IV or primary extra-nasal ENKTL
arm group type: Experimental
description: 6-8 cycles of pegaspargase-COEP chemotherapy with or without local radiotherapy and/or consolidative autologous stem cell transplantation
intervention type: Drug
intervention name: pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone
description: Cyclophosphamide 750 mg/m2 intravenously on day 1, vincristine 1.4 mg/m2 intravenously on day1, etoposide 60mg/m2 intravenously on days 1-3; pegaspargase 2500IU/m2 intramuscularly on day 2, prednisone 100mg orally on days 1-5.
arm group label: Stage I/II nasal ENKTL
arm group label: Stage III/IV or primary extra-nasal ENKTL
criteria: 
gender: All
minimum age: 14 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jun Zhu, Dr.
phone: +86-13910333346
email: zhu-jun@bjcancer.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University Cancer Hospital & Institute
investigator full name: Jun Zhu
investigator title: Dr.
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Lymphoma, Extranodal NK-T-Cell
mesh term: Prednisone
mesh term: Cyclophosphamide
mesh term: Etoposide
mesh term: Vincristine
mesh term: Pegaspargase
sharing ipd: No