<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/NCT04490590</url>
  </required_header>
  <id_info>
    <org_study_id>hnslblzlzx20180814</org_study_id>
    <nct_id>NCT04490590</nct_id>
  </id_info>
  <brief_title>A Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma</brief_title>
  <official_title>A Clinical Trial of Chidamide Combined With Etoposide in Relapsed or Refractory NK/T-cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mingzhi Zhang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhengzhou University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To observe the safety, tolerability and clinical effects of Chidamide Combined With Etoposide&#xD;
      in Relapsed or Refractory NK/T-cell Lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, open-label, one-arm, single center clinical trial, aimed to evaluate&#xD;
      the safety, tolerability, and efficacy of Chidamide Combined With Etoposide in Relapsed or&#xD;
      Refractory NK/T-cell Lymphoma. A total of 30 patients are planned to be enrolled into the&#xD;
      study. Patients with diagnosis of Relapsed or Refractory NK/T-cell Lymphoma will be treated&#xD;
      with Chidamide plus Etoposide capsules. The primary end points are objective responder rate&#xD;
      (ORR) and a time to response(TTR) and response duration (DOR) and progression free&#xD;
      survival(PFS) and adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2016</start_date>
  <completion_date type="Anticipated">October 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2020</primary_completion_date>
  <phase>Phase 4</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>Objective Response Rate (ORR)</measure>
    <time_frame>up to 24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time To Response (TTR)</measure>
    <time_frame>Up to 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS) Progression Free Survival</measure>
    <time_frame>up to 24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>NK/T-Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>Chidamide+ Etoposide capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chidamide: 30mg, twice a week(BIW), PO.&#xD;
Etoposide capsule:50mg, quaque die （QD）, PO, d1-10，21days for one cycle. Patients receive the other treatment of chidamide and etoposide capsule, and those who have achieved PD(progressive disease) will give the other treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chidamide+ Etoposide</intervention_name>
    <description>Patients will receive the treatment of and chidamide and etoposide capsule, and those who have achieved CR（complete response）or PR（partial response）or SD(stable disease)will continue the treatment.</description>
    <arm_group_label>Chidamide+ Etoposide capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.age:10-65 years;Eastern Cooperative Oncology Group (ECOG)score≤2;expected survival≥3&#xD;
        months 2 patients with NK/T Cell Lymphoma diagnosed by immuno-histochemistry (IHC) or&#xD;
        fluorescence in situ hybridization (FISH); 3.Refractory or relapse after at least 2 regimen&#xD;
        4.Once the patient received radiotherapy, need to be more than 3 months away from this&#xD;
        treatment, and it is a non-primary recurrence; 5.No chemotherapy contraindications:&#xD;
        hemoglobin ≥ 100g / L, absolute neutrophil count ≥ 1.5 × 109 / L, platelets ≥ 80 × 109 / L,&#xD;
        ALT, AST ≤ 2 times the upper limit of normal, serum total bilirubin ≤ 1.5 times normal&#xD;
        Upper limit, serum creatinine ≥ 1.5 times normal upper limit, serum protein ≥ 30g / L; 6.At&#xD;
        least one measurable lesion 7.There are no other serious diseases that conflict with this&#xD;
        program, and the cardiopulmonary function is normal; 8.Women of childbearing age must have&#xD;
        a negative urine or blood pregnancy test, and male patients should be contraceptive during&#xD;
        medication; 9.There is no other antitumor treatment, but bisphosphonate for anti-bone&#xD;
        metastasis treatment and other symptomatic treatment can be applied.&#xD;
&#xD;
        10.Can understand the situation of this study and sign the informed consent voluntarily&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. rejecting providing blood preparation;&#xD;
&#xD;
          2. allergic to drug in this study or with hemophagocytic syndrome;&#xD;
&#xD;
          3. rejecting adopting reliable contraceptive method in pregnancy or lactation period;&#xD;
&#xD;
          4. uncontrolled internal medicine disease(including uncontrolled diabetes,severe&#xD;
             incompetence cardiac,lung,liver and pancreas）；&#xD;
&#xD;
          5. with severe infection;&#xD;
&#xD;
          6. with primary or secondary central nervous system tumor invasion;&#xD;
&#xD;
          7. with Chemotherap or radiotherapy contraindication;&#xD;
&#xD;
          8. ever suffered with malignant tumor;&#xD;
&#xD;
          9. Human immunodeficiency virus (HIV)-positive patients&#xD;
&#xD;
         10. Drug abuse or long-term alcohol abuse that affects the evaluation of test results;&#xD;
&#xD;
         11. Have peripheral nervous system disorder or mental disorder;&#xD;
&#xD;
         12. Those who have no legal capacity or whose research is affected by medical or ethical&#xD;
             reasons;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lei Zhang, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Zhengzhou University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lei Zhang, Professor</last_name>
    <phone>13525533696</phone>
    <email>zl2909@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mingzhi Zhang, Professor</last_name>
    <phone>138385656</phone>
    <email>mingzhi_zhang@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Oncology Department of The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450052</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mingzhi Zhang, Pro,Dr</last_name>
      <phone>13838565629</phone>
      <email>mingzhi_zhang@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Zhengzhou University</investigator_affiliation>
    <investigator_full_name>Mingzhi Zhang</investigator_full_name>
    <investigator_title>The director of oncology department of the first affiliated hospital</investigator_title>
  </responsible_party>
  <keyword>Chidamide combined with Etoposide</keyword>
  <keyword>ORR</keyword>
  <keyword>CR</keyword>
  <keyword>PR</keyword>
  <keyword>TTR</keyword>
  <keyword>DOR</keyword>
  <keyword>PFS</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etoposide</mesh_term>
  </intervention_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/NCT04490590
org study id: hnslblzlzx20180814
nct id: NCT04490590
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
To observe the safety, tolerability and clinical effects of Chidamide Combined With Etoposide
      in Relapsed or Refractory NK/T-cell Lymphoma.
This is a prospective, open-label, one-arm, single center clinical trial, aimed to evaluate
      the safety, tolerability, and efficacy of Chidamide Combined With Etoposide in Relapsed or
      Refractory NK/T-cell Lymphoma. A total of 30 patients are planned to be enrolled into the
      study. Patients with diagnosis of Relapsed or Refractory NK/T-cell Lymphoma will be treated
      with Chidamide plus Etoposide capsules. The primary end points are objective responder rate
      (ORR) and a time to response(TTR) and response duration (DOR) and progression free
      survival(PFS) and adverse events.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR)
time frame: up to 24 months
measure: Time To Response (TTR)
time frame: Up to 3 months
measure: Duration of Response (DOR)
time frame: Up to 2 years
measure: Progression Free Survival (PFS) Progression Free Survival
time frame: up to 24 months
arm group label: Chidamide+ Etoposide capsule
arm group type: Experimental
description: Chidamide: 30mg, twice a week(BIW), PO.
Etoposide capsule:50mg, quaque die （QD）, PO, d1-10，21days for one cycle. Patients receive the other treatment of chidamide and etoposide capsule, and those who have achieved PD(progressive disease) will give the other treatment.
intervention type: Drug
intervention name: Chidamide+ Etoposide
description: Patients will receive the treatment of and chidamide and etoposide capsule, and those who have achieved CR（complete response）or PR（partial response）or SD(stable disease)will continue the treatment.
arm group label: Chidamide+ Etoposide capsule
criteria: 
gender: All
minimum age: 10 Years
maximum age: 65 Years
healthy volunteers: No
last name: Lei Zhang, Professor
role: Principal Investigator
affiliation: The First Affiliated Hospital of Zhengzhou University
last name: Lei Zhang, Professor
phone: 13525533696
email: zl2909@163.com
last name: Mingzhi Zhang, Professor
phone: 138385656
email: mingzhi_zhang@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Zhengzhou University
investigator full name: Mingzhi Zhang
investigator title: The director of oncology department of the first affiliated hospital
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Etoposide