<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/NCT03273452</url>
  </required_header>
  <id_info>
    <org_study_id>Xuehw001</org_study_id>
    <nct_id>NCT03273452</nct_id>
  </id_info>
  <brief_title>Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma (PET: Prednisone, Etoposide and Thalidomide)</brief_title>
  <acronym>PET</acronym>
  <official_title>Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma, a Multicentric, Single Arm, Open Label Phase II Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Qingdao University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Qingdao 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>
      This study aims to investigate the efficacy and safety of PET regimen combined with Chidamide&#xD;
      for angioimmunoblastic T cell lymphoma patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients enrolled in the trial would be given prednisone, etoposide, thalidomide and&#xD;
      Chidamide, and the response and side effects are observed and documented.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">May 2019</completion_date>
  <primary_completion_date type="Anticipated">February 2019</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>
    <intervention_model_description>single arm trial, patients enrolled would be treated in this arm.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective remission rate(ORR)</measure>
    <time_frame>every 3 months until 24 months after the last patient's enrollment</time_frame>
    <description>the rate of patients who achieve objective remission after the treatment,including CR (complete remission),CRu (complete remission with unrecovered platelet count) and PR (partial remission).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>duration of remission</measure>
    <time_frame>from the day of remission to the date of first documented progression，up to 24 months after the last patient's enrollment</time_frame>
    <description>from date of complete remission to date of progression, relapse, or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progression free survival</measure>
    <time_frame>from the day of treatment to the date of first documented progression，up to 24 months after the last patient's enrollment</time_frame>
    <description>from date of inclusion to date of progression, relapse, or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>24 months after the last patient's enrollment</time_frame>
    <description>from the date of inclusion to date of death, irrespective of cause</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Angioimmunoblastic T-cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, patients will be given prednisone 100mg,qd,d1-5; etoposide 100mg,qd,d1-5; thalidomide 100mg,qn,d1-14; Chidamide 30mg,biw;</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chidamide</intervention_name>
    <description>Chidamide will be given orally 30mg,biw, along with PET regimen (prednisone 100mg,po,qd,d1-5; etoposide 100mg,po,qd,d1-5; thalidomide 100mg,po,qn,d1-14;)</description>
    <arm_group_label>treatment group</arm_group_label>
    <other_name>PCT regimen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pathologically diagnosed as angioimmunoblastic T cell lymphoma (diagnosed by&#xD;
             pathologic department in IIIA hospitals or verified by certified institutions),&#xD;
             immunohistochemistry should include: CD3, CD4, CD8, CD20, CD10, CD21, CD35, Bcl6,&#xD;
             CXCL13, EBER, PD-1, Ki67.&#xD;
&#xD;
          2. At least on measurable focus (≥1.0*1.0cm by imaging), or at least one evaluable focus;&#xD;
&#xD;
          3. Age 18-75 years, both male and female;&#xD;
&#xD;
          4. ECOG 0-2, KPS≥ 70points;&#xD;
&#xD;
          5. Expected survival ≥3 months;&#xD;
&#xD;
          6. Peripheral blood neutrophil count ≥1.5×10^9/L, platelet count≥ 75×10^9/L, Hb≥ 90g/L;&#xD;
&#xD;
          7. Liver function: bilirubin ≤1.5 times of the normal maximum; AST、ALT≤2 times of the&#xD;
             normal maximum (for patients with liver infiltration AST、ALT≤3 times of the normal&#xD;
             maximum); renal function: blood creatinine ≤2 times the normal maximum;&#xD;
&#xD;
          8. Negative random pregnancy test for fertile women patients within 7 days before&#xD;
             enrollment;&#xD;
&#xD;
          9. No radiation therapy, chemotherapy, targeted therapy nor hemopoietic stem cell&#xD;
             transplantation within 4 weeks before enrollment;&#xD;
&#xD;
         10. No anti-tumor therapy at enrollment, including herbal therapy, immunotherapy and&#xD;
             biologic therapy, symptomatic treatment is not within this range;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women during pregnancy or lactation, and fertile women that are not willing to take&#xD;
             contraceptive measurements;&#xD;
&#xD;
          2. Patients with other malignant tumors simultaneously that have not been effectively&#xD;
             controlled;&#xD;
&#xD;
          3. Patients with history of using HDAC inhibitors;&#xD;
&#xD;
          4. Patients who are allergic to medicine used in the trial, or have metabolic disorders&#xD;
             toward these medicine;&#xD;
&#xD;
          5. Patients with severe active infection;&#xD;
&#xD;
          6. Patients with HIV or syphilis infection;&#xD;
&#xD;
          7. Patients with prolonged QT interval (male &gt; 450ms，female &gt; 470ms), or chronic heart&#xD;
             failure patients with level III or IV cardiac function; or those have the following&#xD;
             heart disease within 6 months before enrollment: acute coronary syndrome, acute heart&#xD;
             failure (heart function level III or IV), distinctive ventricular arrhythmias&#xD;
             (prolonged ventricular tachycardia, ventricular fibrillation, etc);&#xD;
&#xD;
          8. Patients with history of organ transplantation;&#xD;
&#xD;
          9. Patients with history of thrombosis and embolism;&#xD;
&#xD;
         10. Patients with mental disorders or those who are unable to sign a written consent;&#xD;
&#xD;
         11. Patients with drug abuse or long-time alcoholism that may influence the result of the&#xD;
             trial;&#xD;
&#xD;
         12. Patients who do not have capacity of legal transactions;&#xD;
&#xD;
         13. Patients currently in other clinical trials;&#xD;
&#xD;
         14. Those who are recognized as inappropriate for the trial by the investigators;&#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>Hongwei Xue, MD. PhD</last_name>
    <phone>(+86)13475875599</phone>
    <email>Xuehongwei1867@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Affiliated Hospital of Qingdao University</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongwei Xue, MD. PhD</last_name>
      <phone>(+86)13475875599</phone>
      <email>Xuehongwei1867@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Qingdao University</investigator_affiliation>
    <investigator_full_name>Hongwei Xue</investigator_full_name>
    <investigator_title>MD.</investigator_title>
  </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>Immunoblastic Lymphadenopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After the trial is finished, all the data would be available at the principle investigator's location.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </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/NCT03273452
org study id: Xuehw001
nct id: NCT03273452
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the efficacy and safety of PET regimen combined with Chidamide
      for angioimmunoblastic T cell lymphoma patients.
Patients enrolled in the trial would be given prednisone, etoposide, thalidomide and
      Chidamide, and the response and side effects are observed and documented.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: single arm trial, patients enrolled would be treated in this arm.
primary purpose: Treatment
masking: None (Open Label)
measure: Objective remission rate(ORR)
time frame: every 3 months until 24 months after the last patient's enrollment
description: the rate of patients who achieve objective remission after the treatment,including CR (complete remission),CRu (complete remission with unrecovered platelet count) and PR (partial remission).
measure: duration of remission
time frame: from the day of remission to the date of first documented progression，up to 24 months after the last patient's enrollment
description: from date of complete remission to date of progression, relapse, or death from any cause
measure: progression free survival
time frame: from the day of treatment to the date of first documented progression，up to 24 months after the last patient's enrollment
description: from date of inclusion to date of progression, relapse, or death from any cause
measure: overall survival
time frame: 24 months after the last patient's enrollment
description: from the date of inclusion to date of death, irrespective of cause
arm group label: treatment group
arm group type: Experimental
description: In this group, patients will be given prednisone 100mg,qd,d1-5; etoposide 100mg,qd,d1-5; thalidomide 100mg,qn,d1-14; Chidamide 30mg,biw;
intervention type: Drug
intervention name: Chidamide
description: Chidamide will be given orally 30mg,biw, along with PET regimen (prednisone 100mg,po,qd,d1-5; etoposide 100mg,po,qd,d1-5; thalidomide 100mg,po,qn,d1-14;)
arm group label: treatment group
other name: PCT regimen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hongwei Xue, MD. PhD
phone: (+86)13475875599
email: Xuehongwei1867@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Qingdao University
investigator full name: Hongwei Xue
investigator title: MD.
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Immunoblastic Lymphadenopathy
sharing ipd: Yes
ipd description: After the trial is finished, all the data would be available at the principle investigator's location.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)