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/NCT05991973</url>
    </required_header>
    <id_info>
      <org_study_id>IIT20230004C-R2</org_study_id>
      <nct_id>NCT05991973</nct_id>
    </id_info>
    <brief_title>Low-dose Chidamide Maintenance Therapy After Allo-HSCT for T-cell Acute Lymphoblastic Leukemia or T-cell Lymphomas</brief_title>
    <official_title>A Phase ll,Single-center,Single-arm Clinical Study of Low-dose Chidamide Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for T-cell Acute Lymphoblastic Leukemia or T-cell Lymphomas</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhejiang 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>
        Clinical Study on the Safety and Effectiveness of low-dose chidamide maintenance therapy&#xD;
        after allogeneic hematopoietic stem cell transplantation for T-cell acute lymphoblastic&#xD;
        leukemia or T-cell lymphomas.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a phase ll, single-center, single-arm clinical study.This study is indicated for&#xD;
        high-risk of T-cell acute lymphoblastic leukemia or T-cell lymphomas patients. It aims to&#xD;
        evaluate the safety and effectiveness of low-dose chidamide maintenance therapy after&#xD;
        allogeneic hematopoietic stem cell transplantation for T-cell acute lymphoblastic leukemia or&#xD;
        T-cell lymphomas to prevent relapse. 44 patients will be enrolled. The clinical end points&#xD;
        include relapse-free survival, acute or chronic GVHD, non-relapse mortality, and overall&#xD;
        survival, etc.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 15, 2023</start_date>
    <completion_date type="Anticipated">July 2027</completion_date>
    <primary_completion_date type="Anticipated">June 2025</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Relapse-free survival(RFS)</measure>
      <time_frame>At Year 2</time_frame>
      <description>The time from the date of treatment to the occurrence of any of the following:&#xD;
  Death from any cause&#xD;
  Disease recurrence, defined as one of the following:&#xD;
  Leukemia blasts reappeared in peripheral blood, or blasts ≥ 5%, naive monocytes ≥ 5% in bone marrow, or extramedullary lesions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Graft-versus-host disease (GVHD)</measure>
      <time_frame>At Year 2</time_frame>
      <description>Acute GVHD or chronic GVHD incidence after chidamide maintenance therapy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse effects</measure>
      <time_frame>At Year 2</time_frame>
      <description>Drug related adverse effects after chidamide maintenance therapy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measurable residual disease(MRD) status</measure>
      <time_frame>At Year 2</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in t lymphocyte subsets</measure>
      <time_frame>At Year 2</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-relapse mortality (NRM)</measure>
      <time_frame>At Year 2</time_frame>
      <description>Assessment of NRM at Year 2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GVHD-free-relapse-free survival(GRFS)</measure>
      <time_frame>At Year 2</time_frame>
      <description>Assessment of GRFS at Year 2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>At Year 2</time_frame>
      <description>Assessment of OS at Year 2</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>T Lymphoblastic Leukemia/Lymphoma</condition>
    <arm_group>
      <arm_group_label>low-dose chidamide maintenance therapy after allo-HSCT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Chidamide</intervention_name>
      <description>In the time window of 30-180 days after transplantation: oral chidamide 10mg twice a week with a total of 96 courses(4 weeks as a course). If the MRD turns positive during treatment, the dose can be increased to a maximum of 20 mg twice a week, and donor lymphocyte infusion (DLI) is also permitted in the case of MRD positivity.</description>
      <arm_group_label>low-dose chidamide maintenance therapy after allo-HSCT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. T-cell acute lymphoblastic leukemia or T-cell lymphomas (mainly including peripheral&#xD;
               T-cell lymphoma, NK/T-cell lymphoma, T-lymphoblastic lymphoma, etc.) must be diagnosed&#xD;
               before enrollment. The diagnostic criteria refer to the 2016 WHO classification.&#xD;
               Patients is in high-risk group or standard-risk group with MRD-positive patients after&#xD;
               transplantation.&#xD;
  &#xD;
            2. Age 14-70;&#xD;
  &#xD;
            3. Stable hematopoietic reconstitution 90±10 days after receiving allogeneic&#xD;
               hematopoietic stem cell transplantation, no aGVHD or stable aGVHD control and stable&#xD;
               primary disease;&#xD;
  &#xD;
            4. Complete donor chimerism after transplantation;&#xD;
  &#xD;
            5. During the screening period after transplantation (within 4 weeks before Chidanilide&#xD;
               administration), the primary disease is remission and MRD is negative.&#xD;
  &#xD;
            6. Eastern Cooperative Oncology Group (ECOG) physical condition score is 0-2 points;&#xD;
  &#xD;
            7. Creatinine clearance ≥ 60 mL/min (according to the Cockcroft-Gault formula);&#xD;
  &#xD;
            8. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit&#xD;
               of normal range (ULN), total bilirubin ≤ 2 × ULN;&#xD;
  &#xD;
            9. Echocardiography (ECHO) shows left ventricular ejection fraction (LVEF) ≥ 50%&#xD;
  &#xD;
           10. Life expectancy &gt;8 weeks;&#xD;
  &#xD;
           11. Voluntarily sign the informed consent form, understand and comply with the&#xD;
               requirements of the research.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Bone marrow recurrence or extramedullary recurrence after transplantation;&#xD;
  &#xD;
            2. Hemocytopenia after transplantation: white blood cells &lt;2000/ul, platelets &lt;25000/ul;&#xD;
  &#xD;
            3. Active grade 3-4 acute GVHD, or active moderate-to-severe chronic GVHD that cannot be&#xD;
               controlled by drugs;&#xD;
  &#xD;
            4. Active autoimmune diseases, such as SLE, rheumatoid arthritis, etc.;&#xD;
  &#xD;
            5. Currently suffering from clinically significant active cardiovascular disease, such as&#xD;
               uncontrolled arrhythmia, prolonged QTc interval of electrocardiogram, uncontrolled&#xD;
               uncontrolled hypertension, congestive heart failure, any New York Heart Association&#xD;
               (NYHA) functional class 3 or 4 cardiac disease, or a history of myocardial infarction&#xD;
               within 6 months before screening;&#xD;
  &#xD;
            6. Other serious diseases that may limit patients to participate in this trial (such as&#xD;
               advanced infection, uncontrolled diabetes, renal failure);&#xD;
  &#xD;
            7. Known human immunodeficiency virus (HIV) infection, or hepatitis B virus that cannot&#xD;
               be controlled by drugs (HBV-DNA positive, and HBV DNA test value above the upper limit&#xD;
               of normal value) or hepatitis C virus (anti-HCV positive, and HCV viral titer&#xD;
               detection value above the upper limit of normal value) Chronic Infect;&#xD;
  &#xD;
            8. Pregnant or lactating women;&#xD;
  &#xD;
            9. Those who cannot understand and follow the research protocol or cannot sign the&#xD;
               informed consent form;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yanmin Zhao, PhD</last_name>
      <phone>+8615858199217</phone>
      <email>yanminzhao@zju.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>The First Hospital of Zhejiang Medical Colleage Zhejiang University</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310006</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yanmin Zhao, PhD</last_name>
        <phone>+8615858199217</phone>
        <email>yanminzhao@zju.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhejiang University</investigator_affiliation>
      <investigator_full_name>He Huang</investigator_full_name>
      <investigator_title>The President of The First Affiliated Hospital, College of Medicine, Zhejiang University</investigator_title>
    </responsible_party>
    <keyword>chidamide</keyword>
    <keyword>allo-HSCT</keyword>
    <keyword>maintenance therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma</mesh_term>
      <mesh_term>Leukemia</mesh_term>
      <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
      <mesh_term>Leukemia, Lymphoid</mesh_term>
      <mesh_term>Lymphoma, T-Cell</mesh_term>
      <mesh_term>Precursor T-Cell Lymphoblastic Leukemia-Lymphoma</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/NCT05991973
  org study id: IIT20230004C-R2
  nct id: NCT05991973
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Clinical Study on the Safety and Effectiveness of low-dose chidamide maintenance therapy
        after allogeneic hematopoietic stem cell transplantation for T-cell acute lymphoblastic
        leukemia or T-cell lymphomas.
  This is a phase ll, single-center, single-arm clinical study.This study is indicated for
        high-risk of T-cell acute lymphoblastic leukemia or T-cell lymphomas patients. It aims to
        evaluate the safety and effectiveness of low-dose chidamide maintenance therapy after
        allogeneic hematopoietic stem cell transplantation for T-cell acute lymphoblastic leukemia or
        T-cell lymphomas to prevent relapse. 44 patients will be enrolled. The clinical end points
        include relapse-free survival, acute or chronic GVHD, non-relapse mortality, and overall
        survival, etc.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Relapse-free survival(RFS)
  time frame: At Year 2
  description: The time from the date of treatment to the occurrence of any of the following:
  Death from any cause
  Disease recurrence, defined as one of the following:
  Leukemia blasts reappeared in peripheral blood, or blasts ≥ 5%, naive monocytes ≥ 5% in bone marrow, or extramedullary lesions.
  measure: Graft-versus-host disease (GVHD)
  time frame: At Year 2
  description: Acute GVHD or chronic GVHD incidence after chidamide maintenance therapy
  measure: Adverse effects
  time frame: At Year 2
  description: Drug related adverse effects after chidamide maintenance therapy
  measure: Measurable residual disease(MRD) status
  time frame: At Year 2
  measure: Changes in t lymphocyte subsets
  time frame: At Year 2
  measure: Non-relapse mortality (NRM)
  time frame: At Year 2
  description: Assessment of NRM at Year 2
  measure: GVHD-free-relapse-free survival(GRFS)
  time frame: At Year 2
  description: Assessment of GRFS at Year 2
  measure: Overall survival (OS)
  time frame: At Year 2
  description: Assessment of OS at Year 2
  arm group label: low-dose chidamide maintenance therapy after allo-HSCT
  arm group type: Experimental
  intervention type: Drug
  intervention name: Chidamide
  description: In the time window of 30-180 days after transplantation: oral chidamide 10mg twice a week with a total of 96 courses(4 weeks as a course). If the MRD turns positive during treatment, the dose can be increased to a maximum of 20 mg twice a week, and donor lymphocyte infusion (DLI) is also permitted in the case of MRD positivity.
  arm group label: low-dose chidamide maintenance therapy after allo-HSCT
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Yanmin Zhao, PhD
  phone: +8615858199217
  email: yanminzhao@zju.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Zhejiang University
  investigator full name: He Huang
  investigator title: The President of The First Affiliated Hospital, College of Medicine, Zhejiang University
  mesh term: Lymphoma
  mesh term: Leukemia
  mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
  mesh term: Leukemia, Lymphoid
  mesh term: Lymphoma, T-Cell
  mesh term: Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
  sharing ipd: No