<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/NCT03245905</url>
  </required_header>
  <id_info>
    <org_study_id>CSIIT-B09</org_study_id>
    <nct_id>NCT03245905</nct_id>
  </id_info>
  <brief_title>Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-NHL</brief_title>
  <official_title>Study of Chidamide as a Single-agent Treatment for Patients With Relapse or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sun Yat-sen University</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>
      This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide&#xD;
      as a single-agent treatment in patients with relapsed or refractory B-cell Non-Hodgkin's&#xD;
      Lymphoma (NHL).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with relapsed /refractory aggressive B cell lymphoma usually have a poor prognosis.&#xD;
      These patients cannot be treated successfully or tolered with the conventional chemotherapy.&#xD;
      Epigenetic changes in B-cell lymphoma. Thus, epigenetic agents may offer potential improvment&#xD;
      of clinical outcomes. Chidamide is a new type of oral histone deacetylase inhibitor. Our&#xD;
      exploratory research found that Chidamide was effect in some relapsed /refractory B cell&#xD;
      lymphoma patients&#xD;
&#xD;
      . Thus, we will evaluate the efficacy and safety of Chidamide in the patients with aggressive&#xD;
      relapsed refractory B cell lymphoma failed from second line chemotherapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 20, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>objective response rate（ORR）</measure>
    <time_frame>every 6 weeks until 2 years after last patient's enrollment</time_frame>
    <description>Overall response was determined on the basis of investigator assessments according to lymphoma response to immunomodulatory therapy criteria (LYRIC) for Malignant Lymphoma, 2016. Tumor assessments were performed with CT/MRI with or without PET.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression-free survival（PFS）</measure>
    <time_frame>every 6 weeks until 2 years after last patient's enrollment</time_frame>
    <description>The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival（OS）</measure>
    <time_frame>every 6 weeks until 2 years after last patient's enrollment</time_frame>
    <description>Time from randomization to death for any reason Time from randomization to death for any reason Time from randomization to death for any reason Time from randomization to death for any reason</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adverse Events (AEs)</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (NHL)</condition>
  <arm_group>
    <arm_group_label>Chidamide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chidamide should be given at a fixed time with fixed dosage</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chidamide</intervention_name>
    <description>Chidamide 30mg orally BIW. Treatment cycles are repeated every 3 weeks.The maximum duration of treatment is 2 years.</description>
    <arm_group_label>Chidamide</arm_group_label>
    <other_name>epidaza</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosed as B-cell Non-Hodgkin's Lymphoma (NHL) according to &quot;2008 WHO classification&#xD;
             of tumors of haematopoietic and lymphoid tissues&quot;, including Diffuse Large B-Cell&#xD;
             Lymphoma (DLBCL), Mantle Cell Lymphoma (MCL), transformed indolent lymphoma (TL), and&#xD;
             other subtypes that investigators consider to be appropriate to be enrolled;&#xD;
&#xD;
          2. Patients achieved CR or PR in previous cytotoxic chemotherapy, and relapsed later than&#xD;
             6 months after remission;&#xD;
&#xD;
          3. Patients with DLBCL, FL grade3, MALT, LPL and SLL received at least two chemotherapy&#xD;
             regimens, and Patients with FL grade1-2 received at least three chemotherapy regimens;&#xD;
&#xD;
          4. At least one measurable lesion with a longest diameter &gt;1.5cm or a short axis &gt;1.0cm;&#xD;
&#xD;
          5. Age18-75 years;&#xD;
&#xD;
          6. ECOG performance status 0-2;&#xD;
&#xD;
          7. Life expectancy no less than 3 months;&#xD;
&#xD;
          8. Functions within 7 days prior to enrollment: Blood routine test: Hb ≥ 80g/L, absolute&#xD;
             neutrophil count ≥1.5 × 109/L, platelet ≥60 × 109/L; Total bilirubin ≤ 1.5 times of&#xD;
             normal maximum, ALT/AST≤ 2.5 times of normal maximum, for patients with liver&#xD;
             metastasis ALT/AST≤ 5 times of normal maximum; serum creatinin≤1.5 times of normal&#xD;
             maximum or CCr≥ 60ml/min;&#xD;
&#xD;
          9. LVEF ≥ 50% by echocardiography;&#xD;
&#xD;
         10. Contraception during and 4 weeks after the study for patients at child bearing age;&#xD;
&#xD;
         11. Patients have signed the Informed Consent Form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients received Chidamide treatment within 6 months prior to enrollment;&#xD;
&#xD;
          2. Patients with Burkitt Lymphoma, B-lymphoblastic lymphoma, central nervous system&#xD;
             lymphoma and HIV-Associated Lymphoma;&#xD;
&#xD;
          3. Patients with a &quot;currently active&quot; second malignancy;&#xD;
&#xD;
          4. Patients not recovered from non-hematologic toxicities within 4 weeks prior to&#xD;
             enrollment due to chemotherapy, radiation and immunotherapy;&#xD;
&#xD;
          5. Patients receiving or received corticosteroids within 2 weeks prior to enrollment;&#xD;
&#xD;
          6. Patients with cumulative life time dose of Doxorubicin &gt; 450mg/m2;&#xD;
&#xD;
          7. Patients who have been treated with any investigational drug within 4 weeks prior to&#xD;
             enrollment;&#xD;
&#xD;
          8. Women during pregnancy or lactation;&#xD;
&#xD;
          9. Patients with active infection, medical conditions, or mental disorders;&#xD;
&#xD;
         10. Patients with active infection of HBV, HCV or HIV;&#xD;
&#xD;
         11. Congestive heart failure (NYHA grade III/IV), myocardial infarction within 6 months,&#xD;
             QTc elongation with clinical significance (≥480ms), hypertension BP≥150/100 mmHg and&#xD;
             symptomatic coronary heart disease that require treatment;&#xD;
&#xD;
         12. Patients with drug abuse, long term alcoholism that may impact the results of the&#xD;
             trial;&#xD;
&#xD;
         13. Non-appropriate patients for the trial according to the judgment of 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>Huiqiang Huang, Professor</last_name>
    <phone>+86 020 87343350</phone>
    <email>huanghq@sysucc.org.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Medical Oncology, Sun Yat-sen University Cancer Center,</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>HuiQiang Huang</last_name>
      <phone>86-020-87343350</phone>
      <email>huanghq@sysucc.org.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>March 12, 2021</last_update_submitted>
  <last_update_submitted_qc>March 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Huiqiang Huang</investigator_full_name>
    <investigator_title>Chief</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, Non-Hodgkin</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03245905
org study id: CSIIT-B09
nct id: NCT03245905
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective phase II clinical trial to observe the efficacy and safety of Chidamide
      as a single-agent treatment in patients with relapsed or refractory B-cell Non-Hodgkin's
      Lymphoma (NHL).
Patients with relapsed /refractory aggressive B cell lymphoma usually have a poor prognosis.
      These patients cannot be treated successfully or tolered with the conventional chemotherapy.
      Epigenetic changes in B-cell lymphoma. Thus, epigenetic agents may offer potential improvment
      of clinical outcomes. Chidamide is a new type of oral histone deacetylase inhibitor. Our
      exploratory research found that Chidamide was effect in some relapsed /refractory B cell
      lymphoma patients

      . Thus, we will evaluate the efficacy and safety of Chidamide in the patients with aggressive
      relapsed refractory B cell lymphoma failed from second line chemotherapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: objective response rate（ORR）
time frame: every 6 weeks until 2 years after last patient's enrollment
description: Overall response was determined on the basis of investigator assessments according to lymphoma response to immunomodulatory therapy criteria (LYRIC) for Malignant Lymphoma, 2016. Tumor assessments were performed with CT/MRI with or without PET.
measure: progression-free survival（PFS）
time frame: every 6 weeks until 2 years after last patient's enrollment
description: The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death
measure: overall survival（OS）
time frame: every 6 weeks until 2 years after last patient's enrollment
description: Time from randomization to death for any reason Time from randomization to death for any reason Time from randomization to death for any reason Time from randomization to death for any reason
measure: Percentage of Participants With Adverse Events (AEs)
time frame: Up to 36 months
description: An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
arm group label: Chidamide
arm group type: Experimental
description: Chidamide should be given at a fixed time with fixed dosage
intervention type: Drug
intervention name: Chidamide
description: Chidamide 30mg orally BIW. Treatment cycles are repeated every 3 weeks.The maximum duration of treatment is 2 years.
arm group label: Chidamide
other name: epidaza
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Huiqiang Huang, Professor
phone: +86 020 87343350
email: huanghq@sysucc.org.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Huiqiang Huang
investigator title: Chief
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Lymphoma, B-Cell
sharing ipd: No