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/NCT05976997</url>
    </required_header>
    <id_info>
      <org_study_id>CSPC-KBT-PTCL-C01</org_study_id>
      <nct_id>NCT05976997</nct_id>
    </id_info>
    <brief_title>Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)</brief_title>
    <official_title>Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Liling Zhang</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>CSPC Ouyi Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Huazhong University of Science and Technology</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective, single arm, single center study to evaluate the efficacy and safety of&#xD;
        Duvelisib combined with Chidamide in the treatment of newly diagnosed peripheral T-cell&#xD;
        lymphoma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, single arm, single center study, including two phases. It plans to&#xD;
        recruit36 patients with clinically diagnosed primary PTCL who will be treated with Duvelisib&#xD;
        and Chidamide. In the first phase Duvelisib is Oral administration at a dose of 25mg twice a&#xD;
        day, and every 4 weeks (28 days) was a cycle. Next administration will be depend on whether&#xD;
        the efficacy reaches CR in the second phase.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 8, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 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>Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0)</measure>
      <time_frame>from the initiation of the first dose to 28 days after the last dose</time_frame>
      <description>To identify the incidence of AE and SAE in clinical trial</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR)</measure>
      <time_frame>up to 26 weeks</time_frame>
      <description>To evaluate the efficacy of anti-lymphoma</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complete remission rate (CR)</measure>
      <time_frame>up to 26 weeks</time_frame>
      <description>To evaluate the efficacy of anti-lymphoma</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response（DOR）</measure>
      <time_frame>The time from the first assessment as CR or PR to the first assessment as PD or death (due to any cause)，assessed up to 12 months</time_frame>
      <description>To evaluate the efficacy of anti-lymphoma</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression free survival (PFS)</measure>
      <time_frame>From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months</time_frame>
      <description>To evaluate the efficacy of anti-lymphoma</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>From date of randomization until the date of death from any cause, assessed up to 20 months</time_frame>
      <description>To evaluate the efficacy of anti-lymphoma</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Newly Diagnosed Peripheral T-cell Lymphoma</condition>
    <arm_group>
      <arm_group_label>Duvelisib-Chidamide</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with newly diagnosed PTCL were treated with a combination of Duvelisib and Chidamide. The dose of Duvelisib was 25mg twice a day. Every 4 weeks (28 days) is a cycle with a total of 2 cycles.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Duvelisib, Chidamide</intervention_name>
      <description>Duvelisib, 25mg, BID, PO; Chidamide, 20mg, BIW, PO;</description>
      <arm_group_label>Duvelisib-Chidamide</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          -&#xD;
  &#xD;
          1.Age: 18-70 Years (Contains boundary values 18 and 70);&#xD;
  &#xD;
            -  2.The newly diagnosed PTCL confirmed by histopathology is one of the following&#xD;
               subtypes;&#xD;
  &#xD;
               a) Angioimmunoblastic T-cell lymphoma (AITL); b) Follicular T helper cell lymphoma&#xD;
               (T-FHCL); Including but not limited to the above two subtypes;&#xD;
  &#xD;
            -  3.ECOG ≤ 3;&#xD;
  &#xD;
            -  4.At least one measurable or evaluable tumor lesion according to the Lugano-2014&#xD;
               standard;&#xD;
  &#xD;
            -  5.Expected survival ≥ 3 months;&#xD;
  &#xD;
            -  6.Subjects fully understand and voluntarily participate in this study and sign&#xD;
               informed consent;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
  &#xD;
          1.Subjects who have previously received systemic treatment for lymphoma or currently&#xD;
          undergoing anticancer treatment;&#xD;
  &#xD;
            -  2.Subjects with central nervous system (CNS) lymphoma or lymphoma involving CNS;&#xD;
  &#xD;
            -  3.Significant active heart disease within the past 6 months, including: New York Heart&#xD;
               Association (NYHA) Class III/IV congestive heart failure unstable angina pectoris or&#xD;
               angina requiring surgical or medication intervention, and/or myocardial infarction;&#xD;
  &#xD;
            -  4.Uncontrolled systemic fungal, bacterial, or viral infections (defined as persistent&#xD;
               signs/symptoms related to infection that have not improved despite the use of&#xD;
               appropriate antibiotics, antiviral therapy, and/or other treatments);&#xD;
  &#xD;
            -  5.Human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection and history&#xD;
               of severe skin reaction;&#xD;
  &#xD;
            -  6.Subjects with any other active malignant tumor at the time of screening, except for&#xD;
               adequately treated cervical Carcinoma in situ or breast cancer Carcinoma in situ, skin&#xD;
               Basal-cell carcinoma or local skin squamous cell carcinoma;&#xD;
  &#xD;
            -  7.Pregnant women, lactating women, patients who refused to take effective&#xD;
               contraceptive measures during the study;&#xD;
  &#xD;
            -  8.Any serious uncontrolled systemic disease;&#xD;
  &#xD;
            -  9.increasing the risk of the subject or interfering with the test results determined&#xD;
               by the investigator;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Liling Zhang, M.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wuhan Union Hospital, China</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Liling Zhang, M.D</last_name>
      <phone>15871725926</phone>
      <email>15871725926lily1228@sina.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Union Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430022</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Liling Zhang, M.D</last_name>
        <phone>15871725926</phone>
        <email>15871725926lily1228@sina.com</email>
      </contact>
      <investigator>
        <last_name>Liling Zhang, M.D</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
      <investigator_full_name>Liling Zhang</investigator_full_name>
      <investigator_title>chief physician</investigator_title>
    </responsible_party>
    <keyword>Duvelisib</keyword>
    <keyword>Chidamide</keyword>
    <keyword>Peripheral T-cell Lymphoma</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>
    <!-- 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/NCT05976997
  org study id: CSPC-KBT-PTCL-C01
  nct id: NCT05976997
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This is a prospective, single arm, single center study to evaluate the efficacy and safety of
        Duvelisib combined with Chidamide in the treatment of newly diagnosed peripheral T-cell
        lymphoma.
  This is a prospective, single arm, single center study, including two phases. It plans to
        recruit36 patients with clinically diagnosed primary PTCL who will be treated with Duvelisib
        and Chidamide. In the first phase Duvelisib is Oral administration at a dose of 25mg twice a
        day, and every 4 weeks (28 days) was a cycle. Next administration will be depend on whether
        the efficacy reaches CR in the second phase.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0)
  time frame: from the initiation of the first dose to 28 days after the last dose
  description: To identify the incidence of AE and SAE in clinical trial
  measure: Objective response rate (ORR)
  time frame: up to 26 weeks
  description: To evaluate the efficacy of anti-lymphoma
  measure: Complete remission rate (CR)
  time frame: up to 26 weeks
  description: To evaluate the efficacy of anti-lymphoma
  measure: Duration of Response（DOR）
  time frame: The time from the first assessment as CR or PR to the first assessment as PD or death (due to any cause)，assessed up to 12 months
  description: To evaluate the efficacy of anti-lymphoma
  measure: Progression free survival (PFS)
  time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months
  description: To evaluate the efficacy of anti-lymphoma
  measure: Overall survival (OS)
  time frame: From date of randomization until the date of death from any cause, assessed up to 20 months
  description: To evaluate the efficacy of anti-lymphoma
  arm group label: Duvelisib-Chidamide
  arm group type: Experimental
  description: Patients with newly diagnosed PTCL were treated with a combination of Duvelisib and Chidamide. The dose of Duvelisib was 25mg twice a day. Every 4 weeks (28 days) is a cycle with a total of 2 cycles.
  intervention type: Drug
  intervention name: Duvelisib, Chidamide
  description: Duvelisib, 25mg, BID, PO; Chidamide, 20mg, BIW, PO;
  arm group label: Duvelisib-Chidamide
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Liling Zhang, M.D
  role: Principal Investigator
  affiliation: Wuhan Union Hospital, China
  last name: Liling Zhang, M.D
  phone: 15871725926
  email: 15871725926lily1228@sina.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Huazhong University of Science and Technology
  investigator full name: Liling Zhang
  investigator title: chief physician
  mesh term: Lymphoma
  mesh term: Lymphoma, T-Cell
  mesh term: Lymphoma, T-Cell, Peripheral