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/NCT05969158</url>
    </required_header>
    <id_info>
      <org_study_id>B2023-056-01</org_study_id>
      <nct_id>NCT05969158</nct_id>
    </id_info>
    <brief_title>Hetrombopag in Secondary Prevention of XPO-1 Inhibitor-induced Thrombocytopenia in Lymphoma</brief_title>
    <official_title>An Open, Single-center, Phase II Clinical Study of Hetrombopag in Secondary Prevention of XPO-1 Inhibitor Selinexor Combined With Chemotherapy Induced Thrombocytopenia in Lymphoma</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To explore the efficacy and safety of hetrombopag for secondary prevention of&#xD;
        thrombocytopenia caused by XPO-1 inhibitor Selinexor combined with chemotherapy in patients&#xD;
        with lymphoma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To investigate the efficacy and safety of hetrombopag for secondary prevention of&#xD;
        thrombocytopenia in patients with lymphoma treated with XPO-1 inhibitor Selinexor combined&#xD;
        with chemotherapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 1, 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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The incidence of grade 3/4 thrombocytopenia during chemotherapy cycles before and after enrollment.</measure>
      <time_frame>Five days before and five days after chemotherapy</time_frame>
      <description>The incidence of grade 3/4 thrombocytopenia during chemotherapy cycles before and after enrollment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The minimum and maximum values of median platelets before and after secondary prevention.</measure>
      <time_frame>2-3 months</time_frame>
      <description>The minimum and maximum values of median platelets before and after secondary prevention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The duration of PLT &lt; 75×109 /L, PLT &lt; 50×109 /L and PLT &lt; 25×109 /L before and after chemotherapy;</measure>
      <time_frame>2-3 months</time_frame>
      <description>The duration of PLT &lt; 75×109 /L, PLT &lt; 50×109 /L and PLT &lt; 25×109 /L before and after chemotherapy;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The time required for platelet recovery to 100×109/L and 75×109/L;</measure>
      <time_frame>2-3 months</time_frame>
      <description>The time required for platelet recovery to 100×109/L and 75×109/L;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The proportion of patients receiving platelet transfusion, the number and amount of transfusion;</measure>
      <time_frame>2-3 months</time_frame>
      <description>The proportion of patients receiving platelet transfusion, the number and amount of transfusion;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The proportion of reduced or delayed chemotherapy doses in the next cycle due to thrombocytopenia.</measure>
      <time_frame>2-3 months</time_frame>
      <description>The proportion of reduced or delayed chemotherapy doses in the next cycle due to thrombocytopenia.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Chemotherapy-Induced Thrombocytopenia</condition>
    <arm_group>
      <arm_group_label>Hetrombopag</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Hetrombopag 5mg/d</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Hetrombopag</intervention_name>
      <description>After screening, patients who were treated with XPO-1 inhibitor Selinexor combined with chemotherapy and developed chemotherapy-related thrombocytopenia (CIT) after treatment and met the secondary prevention criteria were eligible for inclusion criteria.&#xD;
  The platelet reduction after the previous chemotherapy was used as the control group:&#xD;
  The patients did not routinely receive prophylactic platelet elevation therapy after the previous Selinexor combined chemotherapy, and when PLT &lt; 50×109/L.&#xD;
  Platelet reduction after chemotherapy in secondary prevention unit was used as the experimental group:&#xD;
  The subjects will initiate treatment with 5 mg hetrombopag once a day, starting orally 5 days before chemotherapy, take it for 5 days (D-5-D-1), and continue taking it orally for 5 days after chemotherapy (D1-D5).</description>
      <arm_group_label>Hetrombopag</arm_group_label>
      <other_name>SHR8735</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria：&#xD;
  &#xD;
            1. Age between 18 and 70 years old, gender is not limited;&#xD;
  &#xD;
            2. Lymphoma was confirmed by histopathological or cytological examination;&#xD;
  &#xD;
            3. The patient needs to receive Selinexor combined chemotherapy containing XPO-1&#xD;
               inhibitor, which may include R-CHOP, R-gemox, DICE, DHAP, SMILE, etc., but is not&#xD;
               limited to the above schemes;&#xD;
  &#xD;
            4. Patients who do not routinely undergo preventive platelet elevation therapy after the&#xD;
               above treatment can receive salvage therapeutic platelet elevation therapy only when&#xD;
               the PLT is &lt; 50×109/L;&#xD;
  &#xD;
            5. Patients with the lowest platelet value &lt; 50×109/L after the previous course of&#xD;
               treatment.&#xD;
  &#xD;
            6. The patient's laboratory examination meets the following criteria:&#xD;
  &#xD;
          (1) Adequate bone marrow function at Screening: absolute count of blood neutrophils (ANC)&#xD;
          ≥1.5×109/L; Platelet (PLT) ≥100×109/L; Hemoglobin (HB) ≥90g/L; (2) Liver function: Without&#xD;
          liver metastasis, serum total bilirubin (TBIL) ≤ upper limit of normal (ULN) ×1.5, alanine&#xD;
          aminotransferase (ALT), aspartate aminotransferase (AST) ≤ULN×3; With liver metastasis,&#xD;
          TBIL≤ upper limit of normal (ULN) ×3, ALT, AST≤ULN×5; (3) Kidney function: creatinine (Cr)&#xD;
          ≤1.5×ULN; (4) Coagulation function: International standardized ratio (INR) of prothrombin&#xD;
          time (PT) ≤ULN×1.5;&#xD;
  &#xD;
          7. Able to take oral medications;&#xD;
  &#xD;
          8. Patients voluntarily sign informed consent;&#xD;
  &#xD;
          9. Survival is expected to be ≥12 weeks at the time of screening, and can be treated with&#xD;
          the current chemotherapy regimen for at least 2 cycles;&#xD;
  &#xD;
          10. Subjects of reproductive age who agree to use reliable contraceptive methods throughout&#xD;
          the study period (including male or female condoms, contraceptive foam, contraceptive gel,&#xD;
          contraceptive film, contraceptive paste, contraceptive support, abstinence from sex, and&#xD;
          insertion of an IUD); Excluding female subjects who have undergone hysterectomy, bilateral&#xD;
          salpingectomy, bilateral tubal ligation, or more than 1 year postmenopausal, and male&#xD;
          subjects who have undergone bilateral vasectomy or ligation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Thrombocytopenia caused by non-tumor chemotherapy drugs, including but not limited to&#xD;
               hypersplenism, infection, and bleeding (including severe visceral or intracranial&#xD;
               bleeding), occurred within 6 months before screening;&#xD;
  &#xD;
            2. A history of blood other than lymphoma and chemotherapy-induced thrombocytopenia&#xD;
               (CIT), such as acute lymphoblastic leukemia, acute myeloid leukemia, any myeloid&#xD;
               malignancy, myelodysplastic syndrome, myeloproliferative diseases, and multiple&#xD;
               myeloma;&#xD;
  &#xD;
            3. Any history of arterial or venous thrombosis in the 3 months prior to screening;&#xD;
  &#xD;
            4. Patients had clinical manifestations of severe bleeding (such as gastrointestinal&#xD;
               bleeding, craniocerebral hemorrhage, etc.) 2 weeks before screening, or previous PLT &gt;&#xD;
               400×109/L;&#xD;
  &#xD;
            5. The subject has an allergic reaction to hetrombopag or any of its excipients;&#xD;
  &#xD;
            6. Serious cardiovascular disease (such as NYHA heart function) in the 6 months prior to&#xD;
               screening Score Ⅲ-Ⅳ), arrhythmias known to increase the risk of thromboembolism, such&#xD;
               as atrial fibrillation, after coronary stenting, angioplasty, and coronary artery&#xD;
               bypass grafting;&#xD;
  &#xD;
            7. The subjects participated in other clinical studies of similar platelet enhancing&#xD;
               drugs within 30 days prior to screening;&#xD;
  &#xD;
            8. As assessed by the investigator, the subject has any concomitant medical history that&#xD;
               could impair the subject's safe completion of the study, such as unstable angina&#xD;
               pectoris, renal failure on hemodialysis, or active infection requiring intravenous&#xD;
               antibiotics;&#xD;
  &#xD;
            9. Subjects who are pregnant or breastfeeding, or who cannot use contraception during the&#xD;
               trial;&#xD;
  &#xD;
           10. Other circumstances in which the investigator considers the subject unsuitable for&#xD;
               participation in the study;&#xD;
  &#xD;
           11. HIV infected persons;&#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>Zhiming Li, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sun Yat-sen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zhiming Li, MD.</last_name>
      <phone>+86-13719189172</phone>
      <email>lizhm@sysucc.org.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yu Wang, MD.</last_name>
      <phone>+86-20-87343765</phone>
      <email>wangyu@sysucc.org.cn</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Li Zhiming</investigator_full_name>
      <investigator_title>Chief Physician</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thrombocytopenia</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/NCT05969158
  org study id: B2023-056-01
  nct id: NCT05969158
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To explore the efficacy and safety of hetrombopag for secondary prevention of
        thrombocytopenia caused by XPO-1 inhibitor Selinexor combined with chemotherapy in patients
        with lymphoma.
  To investigate the efficacy and safety of hetrombopag for secondary prevention of
        thrombocytopenia in patients with lymphoma treated with XPO-1 inhibitor Selinexor combined
        with chemotherapy.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The incidence of grade 3/4 thrombocytopenia during chemotherapy cycles before and after enrollment.
  time frame: Five days before and five days after chemotherapy
  description: The incidence of grade 3/4 thrombocytopenia during chemotherapy cycles before and after enrollment.
  measure: The minimum and maximum values of median platelets before and after secondary prevention.
  time frame: 2-3 months
  description: The minimum and maximum values of median platelets before and after secondary prevention.
  measure: The duration of PLT < 75×109 /L, PLT < 50×109 /L and PLT < 25×109 /L before and after chemotherapy;
  time frame: 2-3 months
  description: The duration of PLT < 75×109 /L, PLT < 50×109 /L and PLT < 25×109 /L before and after chemotherapy;
  measure: The time required for platelet recovery to 100×109/L and 75×109/L;
  time frame: 2-3 months
  description: The time required for platelet recovery to 100×109/L and 75×109/L;
  measure: The proportion of patients receiving platelet transfusion, the number and amount of transfusion;
  time frame: 2-3 months
  description: The proportion of patients receiving platelet transfusion, the number and amount of transfusion;
  measure: The proportion of reduced or delayed chemotherapy doses in the next cycle due to thrombocytopenia.
  time frame: 2-3 months
  description: The proportion of reduced or delayed chemotherapy doses in the next cycle due to thrombocytopenia.
  arm group label: Hetrombopag
  arm group type: Experimental
  description: Hetrombopag 5mg/d
  intervention type: Drug
  intervention name: Hetrombopag
  description: After screening, patients who were treated with XPO-1 inhibitor Selinexor combined with chemotherapy and developed chemotherapy-related thrombocytopenia (CIT) after treatment and met the secondary prevention criteria were eligible for inclusion criteria.
  The platelet reduction after the previous chemotherapy was used as the control group:
  The patients did not routinely receive prophylactic platelet elevation therapy after the previous Selinexor combined chemotherapy, and when PLT < 50×109/L.
  Platelet reduction after chemotherapy in secondary prevention unit was used as the experimental group:
  The subjects will initiate treatment with 5 mg hetrombopag once a day, starting orally 5 days before chemotherapy, take it for 5 days (D-5-D-1), and continue taking it orally for 5 days after chemotherapy (D1-D5).
  arm group label: Hetrombopag
  other name: SHR8735
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Zhiming Li, MD.
  role: Principal Investigator
  affiliation: Sun Yat-sen University
  last name: Zhiming Li, MD.
  phone: +86-13719189172
  email: lizhm@sysucc.org.cn
  last name: Yu Wang, MD.
  phone: +86-20-87343765
  email: wangyu@sysucc.org.cn
  responsible party type: Principal Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Li Zhiming
  investigator title: Chief Physician
  mesh term: Thrombocytopenia
  sharing ipd: No