<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/NCT03268889</url>
  </required_header>
  <id_info>
    <org_study_id>Jinzm 001</org_study_id>
    <nct_id>NCT03268889</nct_id>
  </id_info>
  <brief_title>Chidamide With CHOP Regimen for de Novo PTCL Patients (CHOP: Cyclophosphamide, Etoposide, Vincristine and Prednisone; PTCL: Peripheral T Cell Lymphoma)</brief_title>
  <acronym>CHOP</acronym>
  <official_title>Chidamide With Cyclophosphamide, Etoposide, Vincristine and Prednisone for de Novo Peripheral T Cell Lymphoma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Soochow University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Soochow 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 evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After enrollment, patients in this study will be given Chidamide, Cyclophosphamide,&#xD;
      Epirubicin, Vincristine and Prednisone, and the efficacy and safety of this regimen are then&#xD;
      evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 15, 2017</start_date>
  <completion_date type="Anticipated">September 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 15, 2020</primary_completion_date>
  <phase>N/A</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>Complete Remission Rate</measure>
    <time_frame>every 3 months until 30 months after the last patient's enrollment</time_frame>
    <description>the rate of patients who achieve complete remission after the treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression free survival</measure>
    <time_frame>from the day of treatment to the date of first documented progression，up to 30 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>duration of remission</measure>
    <time_frame>from the day of treatment to the date of first documented progression，up to 30 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>overall survival</measure>
    <time_frame>30 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>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>from the date of first cycle of treatment to 30 months after last patient's enrollment</time_frame>
    <description>any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">39</enrollment>
  <condition>Peripheral T Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm, patients would be given the regimen composed of Chidamide, Cyclophosphamide, epirubicin, Vincristine and Prednisone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chidamide</intervention_name>
    <description>Chidamide is given to the patients in this study along with CHOP regimen, to access the efficacy and safety in this cohort of PTCL patients. The dosage of the above regimen is as follows: Chidamide, 30mg,po,biw; Cyclophosphamide 750mg/m2, ivgtt, d1; Epirubicin 70mg/ m2, ivgtt, d1; Vincristine 3mg/ m2, ivgtt, d1; Prednisone 100mg/ m2, po, d1-5.</description>
    <arm_group_label>treatment group</arm_group_label>
    <other_name>CHOP regimen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pathologically diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2008&#xD;
             classification criteria（NK/T cell lymphoma, ALK positive anaplastic large cell&#xD;
             lymphoma and granuloma fungoides excluded）;&#xD;
&#xD;
          2. De novo peripheral T cell lymphoma patients;&#xD;
&#xD;
          3. Age 18-70 years old;&#xD;
&#xD;
          4. ECOG≤2；&#xD;
&#xD;
          5. Female patients not in lactation nor pregnancy, and no intention to concept during the&#xD;
             study and 12 months thereafter. Male patients agree not to impregnate his partner&#xD;
             during the study and 12 months thereafter;&#xD;
&#xD;
          6. The patient should have evaluable foci (lymphnodes with diameter≥1.0cm, or evaluable&#xD;
             skin foci);&#xD;
&#xD;
          7. Willing to sign a written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. T lymphoblast lymphoma;&#xD;
&#xD;
          2. Bone marrow infiltrated with lymphoma cell ≥25%；&#xD;
&#xD;
          3. NT/T cell lymphoma;&#xD;
&#xD;
          4. Granuloma fungoides;&#xD;
&#xD;
          5. Severe impaired liver/ renal function (ALT, Bilirubin or creatinine &gt;3 times the&#xD;
             normal maximum);&#xD;
&#xD;
          6. Uncontrolled infection;&#xD;
&#xD;
          7. Organic cardiopathy with clinical manifestation or impaired cardiac function (NYHA ≥&#xD;
             level 2);&#xD;
&#xD;
          8. With other tumors;&#xD;
&#xD;
          9. With other condition that cause the patient unable to sign the written consent;&#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>Zhengming Jin, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Soochow University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhengming Jin, MD,PhD</last_name>
    <phone>（+86）512-65223637</phone>
    <email>suzhouhematology@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>the First Affiliated Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhengming Jin, MD, PhD</last_name>
      <phone>(+86)512-67781856</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chidamide, CHOP regimen</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All the data would be available at the First Affiliated Hospital after the study is finished</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>From the time of study finish</ipd_time_frame>
  </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/NCT03268889
org study id: Jinzm 001
nct id: NCT03268889
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates the efficacy and safety of Chidamide plus CHOP regimen for de novo PTCL
      patients.
After enrollment, patients in this study will be given Chidamide, Cyclophosphamide,
      Epirubicin, Vincristine and Prednisone, and the efficacy and safety of this regimen are then
      evaluated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Complete Remission Rate
time frame: every 3 months until 30 months after the last patient's enrollment
description: the rate of patients who achieve complete remission after the treatment
measure: progression free survival
time frame: from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment
description: from date of inclusion to date of progression, relapse, or death from any cause
measure: duration of remission
time frame: from the day of treatment to the date of first documented progression，up to 30 months after the last patient's enrollment
description: from date of complete remission to date of progression, relapse, or death from any cause
measure: overall survival
time frame: 30 months after the last patient's enrollment
description: from the date of inclusion to date of death, irrespective of cause
measure: adverse events
time frame: from the date of first cycle of treatment to 30 months after last patient's enrollment
description: any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
arm group label: treatment group
arm group type: Experimental
description: In this arm, patients would be given the regimen composed of Chidamide, Cyclophosphamide, epirubicin, Vincristine and Prednisone.
intervention type: Drug
intervention name: Chidamide
description: Chidamide is given to the patients in this study along with CHOP regimen, to access the efficacy and safety in this cohort of PTCL patients. The dosage of the above regimen is as follows: Chidamide, 30mg,po,biw; Cyclophosphamide 750mg/m2, ivgtt, d1; Epirubicin 70mg/ m2, ivgtt, d1; Vincristine 3mg/ m2, ivgtt, d1; Prednisone 100mg/ m2, po, d1-5.
arm group label: treatment group
other name: CHOP regimen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Zhengming Jin, MD,PhD
role: Principal Investigator
affiliation: The First Affiliated Hospital of Soochow University
last name: Zhengming Jin, MD,PhD
phone: （+86）512-65223637
email: suzhouhematology@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
sharing ipd: Yes
ipd description: All the data would be available at the First Affiliated Hospital after the study is finished
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: From the time of study finish