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/NCT05974085</url>
    </required_header>
    <id_info>
      <org_study_id>XRCHOP</org_study_id>
      <nct_id>NCT05974085</nct_id>
    </id_info>
    <brief_title>XPO-1 in Combination With RCHOP for DH/TH Lymphoma</brief_title>
    <official_title>Prospective, Single-arm, Single-center, Phase II Clinical Study of XPO-1 Inhibitor Selinexor in Combination With RCHOP Regimen in the Treatment of Double Hit/Triple Hit B Cell Lymphoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhejiang Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhejiang Cancer Hospital</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>
        The purpose of this study was to evaluate the efficacy and safety of Selinexor in combination&#xD;
        with RCHOP in first-line treatment of patients with DH or TH lymphoma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, single-arm, single-center clinical study evaluating the first-line&#xD;
        treatment of DH or TH lymphoma with Selinexor combined with RCHOP. There are three stages:&#xD;
        screening, treatment and follow-up period. The screening period was 28 days before the first&#xD;
        dose. Treatment period: Enrolled subjects were treated with Selinexor in combination with&#xD;
        RCHOP every 21 days for a maximum of 6 cycles until the efficacy of SD or PD, drug toxicity&#xD;
        became intolerable, subject withdrawal of consent, death, or continuation of chemotherapy&#xD;
        deemed unsuitable by the investigator. Lugano2014 criteria were used to evaluate the efficacy&#xD;
        during treatment. Objective effective rate, safety and survival data were observed during the&#xD;
        experiment. After stopping treatment or completing 6 cycles of treatment, subjects entered&#xD;
        the follow-up period, during which imaging evaluation (enhanced CT at focal site is&#xD;
        recommended) was performed at the following intervals: once every 3 months for 2 years, once&#xD;
        every 6 months for 3-5 years, and once every 5 years until the end of the follow-up period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>Objective Response Rate</measure>
      <time_frame>From date of first day of treatment until the date of last day of treatment</time_frame>
      <description>CR plus PR</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PFS</measure>
      <time_frame>From date of first day of treatmentuntil the date of first documented progression, assessed up to 24 months</time_frame>
      <description>Progression Free Survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>OS</measure>
      <time_frame>From date of first day of treatmentuntil the date of first documented date of death from any cause, assessed up to 24 months</time_frame>
      <description>Overall Survival</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AE and SAE</measure>
      <time_frame>From date of first day of treatmentuntil 30 day after last treatment</time_frame>
      <description>Adverse event and serious adverse event</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Double Hit Lymphoma</condition>
    <condition>Triple Hit Lymphoma</condition>
    <arm_group>
      <arm_group_label>Selinexor+RCHOP</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Selinexor: 60 mg QW Rituximab: 375 mg/m2, d0 Vincristine: 4 mg, d1 Epirubicin: 75 mg/m2, d1 or Liposomal doxorubicin: 35 mg/m2, d1 Cyclophosphamide: 750 mg/m2, d1 Prednisone: 100 mg, d1-5</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Selinexor+RCHOP</intervention_name>
      <description>XPO-1 inhibitor selinexor in combination with RCHOP</description>
      <arm_group_label>Selinexor+RCHOP</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Volunteer to participate in clinical studies&#xD;
  &#xD;
            2. Age: 18~75 (inclusive), male and female.&#xD;
  &#xD;
            3. Histopathologically confirmed high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6&#xD;
               gene rearrangement.&#xD;
  &#xD;
            4. No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor therapy.&#xD;
  &#xD;
            5. ECOG score is 0-2.&#xD;
  &#xD;
            6. there must be at least one evaluable or measurable lesion that meets Lugano2014&#xD;
               criteria.&#xD;
  &#xD;
            7. Adequate organ and bone marrow function.&#xD;
  &#xD;
            8. Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination.&#xD;
  &#xD;
            9. Serum pregnancy test negative&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Left ventricular ejection fraction (LVEF) ≥ 50% in cardiac function examination. 1)&#xD;
               Mixed lymphoma (Hodgkin's lymphoma + non-Hodgkin's lymphoma), or DLBCL transformed&#xD;
               from inert non-Hodgkin's lymphoma, or gray zone lymphoma (lymphoma between DLBCL and&#xD;
               Hodgkin's lymphoma), or inert lymphoma with MYC, BCL2, BCL6 gene rearrangement.&#xD;
  &#xD;
            2. known central nervous system involvement.&#xD;
  &#xD;
            3. received prior anti-tumor therapy&#xD;
  &#xD;
            4. Is participating in another clinical study or is receiving the first investigational&#xD;
               drug less than 4 weeks after the completion of treatment in the previous clinical&#xD;
               study&#xD;
  &#xD;
            5. Had other malignant tumors in the past 5 years&#xD;
  &#xD;
            6. Major surgery was performed within 28 days prior to study initiation&#xD;
  &#xD;
            7. Cardiovascular function is unstable&#xD;
  &#xD;
            8. Active infection&#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_official>
      <last_name>Cong Li</last_name>
      <role>Principal Investigator</role>
      <affiliation>Zhejiang Cancer Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cong Li</last_name>
      <phone>15267115611</phone>
      <email>licong@zjcc.org.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Zhejiang Cancer Hospital</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhenjiang</state>
          <zip>310005</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cong Li, doctor</last_name>
        <phone>15267115611</phone>
        <email>licong@zjcc.org.cn</email>
      </contact>
      <contact_backup>
        <last_name>Haiyan Yang, doctor</last_name>
        <phone>0571-88122192</phone>
        <email>yanghy@zjcc.org.cn</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>January 13, 2022</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhejiang Cancer Hospital</investigator_affiliation>
      <investigator_full_name>Yang haiyan</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <keyword>Double/Triple Hit Lymphoma</keyword>
    <keyword>Selinexor</keyword>
    <keyword>RCHOP</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>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/NCT05974085
  org study id: XRCHOP
  nct id: NCT05974085
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study was to evaluate the efficacy and safety of Selinexor in combination
        with RCHOP in first-line treatment of patients with DH or TH lymphoma.
  This is a prospective, single-arm, single-center clinical study evaluating the first-line
        treatment of DH or TH lymphoma with Selinexor combined with RCHOP. There are three stages:
        screening, treatment and follow-up period. The screening period was 28 days before the first
        dose. Treatment period: Enrolled subjects were treated with Selinexor in combination with
        RCHOP every 21 days for a maximum of 6 cycles until the efficacy of SD or PD, drug toxicity
        became intolerable, subject withdrawal of consent, death, or continuation of chemotherapy
        deemed unsuitable by the investigator. Lugano2014 criteria were used to evaluate the efficacy
        during treatment. Objective effective rate, safety and survival data were observed during the
        experiment. After stopping treatment or completing 6 cycles of treatment, subjects entered
        the follow-up period, during which imaging evaluation (enhanced CT at focal site is
        recommended) was performed at the following intervals: once every 3 months for 2 years, once
        every 6 months for 3-5 years, and once every 5 years until the end of the follow-up period.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective Response Rate
  time frame: From date of first day of treatment until the date of last day of treatment
  description: CR plus PR
  measure: PFS
  time frame: From date of first day of treatmentuntil the date of first documented progression, assessed up to 24 months
  description: Progression Free Survival
  measure: OS
  time frame: From date of first day of treatmentuntil the date of first documented date of death from any cause, assessed up to 24 months
  description: Overall Survival
  measure: AE and SAE
  time frame: From date of first day of treatmentuntil 30 day after last treatment
  description: Adverse event and serious adverse event
  arm group label: Selinexor+RCHOP
  arm group type: Experimental
  description: Selinexor: 60 mg QW Rituximab: 375 mg/m2, d0 Vincristine: 4 mg, d1 Epirubicin: 75 mg/m2, d1 or Liposomal doxorubicin: 35 mg/m2, d1 Cyclophosphamide: 750 mg/m2, d1 Prednisone: 100 mg, d1-5
  intervention type: Drug
  intervention name: Selinexor+RCHOP
  description: XPO-1 inhibitor selinexor in combination with RCHOP
  arm group label: Selinexor+RCHOP
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Cong Li
  role: Principal Investigator
  affiliation: Zhejiang Cancer Hospital
  last name: Cong Li
  phone: 15267115611
  email: licong@zjcc.org.cn
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Zhejiang Cancer Hospital
  investigator full name: Yang haiyan
  investigator title: Director
  mesh term: Lymphoma
  sharing ipd: No