<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/NCT04405375</url>
  </required_header>
  <id_info>
    <org_study_id>TRhos-ENKTCL-6</org_study_id>
    <nct_id>NCT04405375</nct_id>
  </id_info>
  <brief_title>GPED Regimen for Relapsed/Refractory or Advanced ENKTCL</brief_title>
  <official_title>Gemcitabine, Pegaspargase, Etoposide, and Dexamethasone (GPED) for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Tongren Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Tongren Hospital</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 purpose of this study is to evaluate the efficacy and safety of gemcitabine,&#xD;
      pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of Relapsed/Refractory or&#xD;
      advanced NK/T-cell lymphoma patients (ENKTCL).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pegaspargase is the cornor stone for the treatment of ENKTCL, and gemcitabine has been shown&#xD;
      to be active in ENKTCL. For several patients with relapsed/refractory or advance ENKTCL,&#xD;
      hemophagocytic sysdrome (HPS) occurs, and the prognosis is very poor. Studies have found that&#xD;
      etoposide and dexamethasone may be effective in controlling HPS. Thus, this study aims to&#xD;
      evaluate the role of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the&#xD;
      treatment of relapsed/refractory or advance ENKTCL, wishing to improve the prognosis for&#xD;
      these patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 21, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>2-year progression free survival (PFS) rate</measure>
    <time_frame>From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months</time_frame>
    <description>PFS is defined as date of enrollment to date of disease progression, relapse, death of any reason, or last follow-up, whichever comes first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR)</measure>
    <time_frame>evaluated every 2 cycles of treamtent, up to one month after the end of treatment</time_frame>
    <description>evaluated by PET-CT and MRI, according to Lugano 2014 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete response rate (CRR)</measure>
    <time_frame>evaluated every 2 cycles of treamtent, up to one month after the end of treatment</time_frame>
    <description>evaluated by PET-CT and MRI, according to Lugano 2014 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2-year overall survial (OS) rate</measure>
    <time_frame>From date of enrollment until the date of death from any cause or last follow-up, assessed up to 24 months</time_frame>
    <description>OS is defined as date of enrollment to date of death of any reason, or last follow-up, whichever comes first.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">29</enrollment>
  <condition>Extranodal NK/T-cell Lymphoma, Nasal Type</condition>
  <arm_group>
    <arm_group_label>treatment arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>gemcitabine 1.25g/㎡ d1, pegaspargase 2500IU/㎡ d1 (max dose =&lt;3750IU) etoposide 75mg/㎡ d1-3 dexamethasone 20mg d1-4 repeated every 21 days, up to 6 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>gemcitabin</intervention_name>
    <description>1.25g/㎡ d1, repeated every 21 days</description>
    <arm_group_label>treatment arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pegaspargase</intervention_name>
    <description>2500IU/㎡ d1, total dose=&lt;3750IU, repeated every 21 days</description>
    <arm_group_label>treatment arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etoposide</intervention_name>
    <description>75mg/㎡ d1-3, repeated every 21 days</description>
    <arm_group_label>treatment arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>20mg d1-4</description>
    <arm_group_label>treatment arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma&#xD;
             according to WHO 2016 criteria.&#xD;
&#xD;
          -  refractory or relapsed after initial remission, or stage III-IV de novo patients&#xD;
&#xD;
          -  PET/CT or CT/MRI with at least one objectively evaluable lesion.&#xD;
&#xD;
          -  General status ECOG score 0-3 points.&#xD;
&#xD;
          -  The laboratory test within 1 week before enrollment meets the following conditions:&#xD;
&#xD;
          -  Blood routine: Hb&gt;80g/L, PLT&gt;50×10e9/L.&#xD;
&#xD;
          -  Liver function: ALT, AST, TBIL ≤2 times the upper limit of normal.&#xD;
&#xD;
          -  Renal function: Cr is normal.&#xD;
&#xD;
          -  Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction,&#xD;
             arrhythmia or atrioventricular conduction above I Blocking.&#xD;
&#xD;
          -  Sign the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active infection requires ICU treatment. Concomitant HIV infection or active infection&#xD;
             with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same&#xD;
             time are notexcluded.&#xD;
&#xD;
          -  Significant organ dysfunction Pregnant and lactating women.&#xD;
&#xD;
          -  Those who were known to be allergic to drugs in the study regimen.&#xD;
&#xD;
          -  Patients with other tumors who require surgery or chemotherapy within 6 months.&#xD;
&#xD;
          -  Other experimental drugs are being used.&#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>Beijing Tongren Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liang Wang, MD</last_name>
      <phone>+8615001108693</phone>
      <email>wangliangtrhos@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 24, 2020</last_update_submitted>
  <last_update_submitted_qc>May 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Tongren Hospital</investigator_affiliation>
    <investigator_full_name>JING-WEN WANG</investigator_full_name>
    <investigator_title>Director of department of hematology</investigator_title>
  </responsible_party>
  <keyword>extranodal NK/T-cell lymphoma</keyword>
  <keyword>gemcitabine</keyword>
  <keyword>etoposide</keyword>
  <keyword>dexamethasone</keyword>
  <keyword>pegaspargase</keyword>
  <keyword>hemophagocytic syndrome</keyword>
  <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>Dexamethasone</mesh_term>
    <mesh_term>Etoposide</mesh_term>
    <mesh_term>Pegaspargase</mesh_term>
    <mesh_term>Gemcitabine</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/NCT04405375
org study id: TRhos-ENKTCL-6
nct id: NCT04405375
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of gemcitabine,
      pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of Relapsed/Refractory or
      advanced NK/T-cell lymphoma patients (ENKTCL).
Pegaspargase is the cornor stone for the treatment of ENKTCL, and gemcitabine has been shown
      to be active in ENKTCL. For several patients with relapsed/refractory or advance ENKTCL,
      hemophagocytic sysdrome (HPS) occurs, and the prognosis is very poor. Studies have found that
      etoposide and dexamethasone may be effective in controlling HPS. Thus, this study aims to
      evaluate the role of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the
      treatment of relapsed/refractory or advance ENKTCL, wishing to improve the prognosis for
      these patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 2-year progression free survival (PFS) rate
time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
description: PFS is defined as date of enrollment to date of disease progression, relapse, death of any reason, or last follow-up, whichever comes first.
measure: Overall response rate (ORR)
time frame: evaluated every 2 cycles of treamtent, up to one month after the end of treatment
description: evaluated by PET-CT and MRI, according to Lugano 2014 criteria
measure: Complete response rate (CRR)
time frame: evaluated every 2 cycles of treamtent, up to one month after the end of treatment
description: evaluated by PET-CT and MRI, according to Lugano 2014 criteria
measure: 2-year overall survial (OS) rate
time frame: From date of enrollment until the date of death from any cause or last follow-up, assessed up to 24 months
description: OS is defined as date of enrollment to date of death of any reason, or last follow-up, whichever comes first.
arm group label: treatment arm
arm group type: Experimental
description: gemcitabine 1.25g/㎡ d1, pegaspargase 2500IU/㎡ d1 (max dose =<3750IU) etoposide 75mg/㎡ d1-3 dexamethasone 20mg d1-4 repeated every 21 days, up to 6 cycles.
intervention type: Drug
intervention name: gemcitabin
description: 1.25g/㎡ d1, repeated every 21 days
arm group label: treatment arm
intervention type: Drug
intervention name: Pegaspargase
description: 2500IU/㎡ d1, total dose=<3750IU, repeated every 21 days
arm group label: treatment arm
intervention type: Drug
intervention name: Etoposide
description: 75mg/㎡ d1-3, repeated every 21 days
arm group label: treatment arm
intervention type: Drug
intervention name: Dexamethasone
description: 20mg d1-4
arm group label: treatment arm
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: Beijing Tongren Hospital
investigator full name: JING-WEN WANG
investigator title: Director of department of hematology
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Lymphoma, Extranodal NK-T-Cell
mesh term: Dexamethasone
mesh term: Etoposide
mesh term: Pegaspargase
mesh term: Gemcitabine
sharing ipd: No