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/NCT06037239</url>
    </required_header>
    <id_info>
      <org_study_id>PUMCH-NHL-015</org_study_id>
      <nct_id>NCT06037239</nct_id>
    </id_info>
    <brief_title>Phase I/II Study of Linperlisib Plus Chidamide for R/R Cutaneous T-cell Lymphoma: a Prospective, Single-center Study</brief_title>
    <official_title>Phase I/II Study of Linperlisib in Combination With Chidamide for Relapsed and Refractory Cutaneous T-cell Lymphoma: a Prospective, Single-center Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</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>
        HDAC inhibitor chidamide and PI3K inhibitor linperlisib has shown clinical activity as mono&#xD;
        therapy in PTCL. The combination of duvelisib and romidepsin is highly active against&#xD;
        relapsed and refractory T-cell lymphomas including cutaneous T-cell lymphomas (CTCLs). The&#xD;
        aim of this study is to further explore the efficacy and safety of HDAC inhibitor chidamide&#xD;
        combined with PI3K inhibitor linperlisib in the treatment of relapsed and refractory CTCLs.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">July 2025</completion_date>
    <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
    <phase>Phase 1/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>Recommended phase 2 dose (RP2D)（Phase 1）</measure>
      <time_frame>4 weeks since the date of first dose</time_frame>
      <description>Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) will be established according to the incidence of dose-limiting toxicities (DLTs) of escalated doses of linperlisib.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Objective response rate (ORR)（Phase 2）</measure>
      <time_frame>evaluated every 3 months (up to 24 months）</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival</measure>
      <time_frame>Baseline up to data cut-off (up to 5 years)</time_frame>
      <description>Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, or death from any cause, whichever occurred first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>Baseline up to data cut-off (up to 5 years)</time_frame>
      <description>Overall survival was defined as the time from the date of enrollment to the date of death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>complete remission (CR) rate</measure>
      <time_frame>evaluated every 3 months (up to 24 months）</time_frame>
      <description>Treatment responses were assessed according to the 2014 Lugano classification criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>adverse events</measure>
      <time_frame>evaluated every treatment cycle (up to 24 months）</time_frame>
      <description>Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">53</enrollment>
    <condition>Cutaneous T-cell Lymphoma</condition>
    <arm_group>
      <arm_group_label>Linperlisib + Chidamide</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Linperlisib combined with chidamide</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Linperlisib in combined with Chidamide</intervention_name>
      <description>Phase 1: dose escalation phase. Drug Linperlisib: 3 dose level of 40mg, 60mg, 80mg qd; Drug Chidamide: fixed dose of 20mg twice weekly.&#xD;
  Phase 2：dose expansion phase. Drug Linperlisib: RP2D established in the phase I study; Drug Chidamide: fixed dose of 20mg twice weekly in a 4-week cycle</description>
      <arm_group_label>Linperlisib + Chidamide</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ages 18-75;&#xD;
  &#xD;
            -  Mycosis fungoides and Sezary syndrome confirmed by histopathology;&#xD;
  &#xD;
            -  Patients with measurable lesions, with or without extra-cutaneous lesions, and&#xD;
               clinical stage IIB-IVB;&#xD;
  &#xD;
            -  No remission or relapse after at least one systemic therapy (including total body&#xD;
               electron irradiation, becarodine, retinoic acid, interferon, photoseparation and&#xD;
               replacement, methotrexate, chidamide, etc.);&#xD;
  &#xD;
            -  ECOG score of 0-2;&#xD;
  &#xD;
            -  Adequate bone marrow hematopoietic function: neutrophil count (ANC) ≥1.5×109/L,&#xD;
               platelet count (PLT) ≥80×109/L, hemoglobin (HGB) ≥90g/L;&#xD;
  &#xD;
            -  Adequate organ function: NYHA grade 1-2, LVEF≥50%, ALT&lt;2.5UNL, TBil&lt;1.5ULN, SPO2 &gt;&#xD;
               93%@RA, SCr&gt;60ml/(min·1.73m2);&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Acute myocardial infarction or unstable angina, congestive heart failure, symptomatic&#xD;
               arrhythmia, and significantly prolonged QT interval (&gt; 450ms in men and &gt; 470ms in&#xD;
               women) within 6 months;&#xD;
  &#xD;
            -  Uncontrolled active infections;&#xD;
  &#xD;
            -  Active hepatitis B and C infection (hepatitis B virus DNA over 1×103 copies /mL is&#xD;
               excluded, hepatitis C virus RNA over 1×103 copies /mL is excluded)&#xD;
  &#xD;
            -  Pregnant or lactating women;&#xD;
  &#xD;
            -  Investigators judged that they were not suitable to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Wei Zhang</last_name>
      <phone>+8613681473557</phone>
      <email>vv1223@vip.sina.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Chong Wei</last_name>
      <phone>+8613521760705</phone>
      <email>QH5035@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zhang Wei</last_name>
        <phone>+86 136 8147 3557</phone>
        <email>vv1223@vip.sina.com</email>
      </contact>
      <contact_backup>
        <last_name>Wei Chong</last_name>
        <phone>+86 13521760705</phone>
        <email>QH5035@163.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </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, T-Cell, Cutaneous</mesh_term>
    </condition_browse>
    <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/NCT06037239
  org study id: PUMCH-NHL-015
  nct id: NCT06037239
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  HDAC inhibitor chidamide and PI3K inhibitor linperlisib has shown clinical activity as mono
        therapy in PTCL. The combination of duvelisib and romidepsin is highly active against
        relapsed and refractory T-cell lymphomas including cutaneous T-cell lymphomas (CTCLs). The
        aim of this study is to further explore the efficacy and safety of HDAC inhibitor chidamide
        combined with PI3K inhibitor linperlisib in the treatment of relapsed and refractory CTCLs.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Recommended phase 2 dose (RP2D)（Phase 1）
  time frame: 4 weeks since the date of first dose
  description: Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) will be established according to the incidence of dose-limiting toxicities (DLTs) of escalated doses of linperlisib.
  measure: Objective response rate (ORR)（Phase 2）
  time frame: evaluated every 3 months (up to 24 months）
  measure: Progression-free survival
  time frame: Baseline up to data cut-off (up to 5 years)
  description: Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, or death from any cause, whichever occurred first.
  measure: Overall survival
  time frame: Baseline up to data cut-off (up to 5 years)
  description: Overall survival was defined as the time from the date of enrollment to the date of death from any cause.
  measure: complete remission (CR) rate
  time frame: evaluated every 3 months (up to 24 months）
  description: Treatment responses were assessed according to the 2014 Lugano classification criteria
  measure: adverse events
  time frame: evaluated every treatment cycle (up to 24 months）
  description: Graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
  arm group label: Linperlisib + Chidamide
  arm group type: Experimental
  description: Linperlisib combined with chidamide
  intervention type: Drug
  intervention name: Linperlisib in combined with Chidamide
  description: Phase 1: dose escalation phase. Drug Linperlisib: 3 dose level of 40mg, 60mg, 80mg qd; Drug Chidamide: fixed dose of 20mg twice weekly.
  Phase 2：dose expansion phase. Drug Linperlisib: RP2D established in the phase I study; Drug Chidamide: fixed dose of 20mg twice weekly in a 4-week cycle
  arm group label: Linperlisib + Chidamide
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Wei Zhang
  phone: +8613681473557
  email: vv1223@vip.sina.com
  last name: Chong Wei
  phone: +8613521760705
  email: QH5035@163.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Lymphoma
  mesh term: Lymphoma, T-Cell
  mesh term: Lymphoma, T-Cell, Peripheral
  mesh term: Lymphoma, T-Cell, Cutaneous
  sharing ipd: No