xml: <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/NCT05967949</url>
    </required_header>
    <id_info>
      <org_study_id>CS123</org_study_id>
      <nct_id>NCT05967949</nct_id>
    </id_info>
    <brief_title>A Retrospective Clinical Study on the First-line Maintenance Treatment of PTCL With Chidamide.</brief_title>
    <official_title>A Retrospective (Non-interventional) Clinical Study on the First-line Maintenance Treatment of Peripheral T-cell Lymphoma (PTCL) With Chidamide.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital with Nanjing Medical 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 efficacy and safety of chidamide in first-line maintenance therapy for PTCL will be&#xD;
        assessed through a retrospective case analysis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study design belongs to a retrospective study, collecting information on patients with&#xD;
        PTCL who were diagnosed and treated with chidamide as maintenance therapy at our center. The&#xD;
        collected data includes age, gender, previous treatment regimens, results of auxiliary&#xD;
        examinations (such as blood routine, biochemistry, bone marrow cytology, pathology, flow&#xD;
        cytometry, NGS, etc.), as well as PET-CT images. The safety and efficacy of Chidemide as&#xD;
        first-line maintenance therapy in PTCL will be analyzed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>PFS</measure>
      <time_frame>2 years</time_frame>
      <description>progression free survival</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>OS</measure>
      <time_frame>2 years</time_frame>
      <description>overall survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CR</measure>
      <time_frame>2 years</time_frame>
      <description>complete remission</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>DOR</measure>
      <time_frame>2 years</time_frame>
      <description>duration of remission</description>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>PTCL</condition>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>chidamide</intervention_name>
      <description>This subset of patients received chidamide as first-line maintenance therapy.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adults diagnosed with PTCL, who have undergone first-line treatment and are using chidemide&#xD;
          as maintenance therapy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  (1) Age: 18 years and older; (2) Gender: Male/Female; (3) Diagnosed with PTCL; (4)&#xD;
               Received chidamide as maintenance therapy after first-line treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  (1) Patients with other types of lymphomas; (2) Pregnant women.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>wei xu</last_name>
      <phone>+862568302182</phone>
      <email>xuwei10000@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hematological Department, People's Hospital of Jiangsu Province</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210029</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wei Xu, PhD</last_name>
        <phone>+86-2568302182</phone>
        <email>xuwei10000@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>chidamide</keyword>
    <keyword>maintenance treatment</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05967949
  org study id: CS123
  nct id: NCT05967949
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The efficacy and safety of chidamide in first-line maintenance therapy for PTCL will be
        assessed through a retrospective case analysis.
  The study design belongs to a retrospective study, collecting information on patients with
        PTCL who were diagnosed and treated with chidamide as maintenance therapy at our center. The
        collected data includes age, gender, previous treatment regimens, results of auxiliary
        examinations (such as blood routine, biochemistry, bone marrow cytology, pathology, flow
        cytometry, NGS, etc.), as well as PET-CT images. The safety and efficacy of Chidemide as
        first-line maintenance therapy in PTCL will be analyzed.
  observational model: Cohort
  time perspective: Retrospective
  measure: PFS
  time frame: 2 years
  description: progression free survival
  measure: OS
  time frame: 2 years
  description: overall survival
  measure: CR
  time frame: 2 years
  description: complete remission
  measure: DOR
  time frame: 2 years
  description: duration of remission
  intervention type: Drug
  intervention name: chidamide
  description: This subset of patients received chidamide as first-line maintenance therapy.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: wei xu
  phone: +862568302182
  email: xuwei10000@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  sharing ipd: No