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/NCT05975996</url>
    </required_header>
    <id_info>
      <org_study_id>ALG-HPAG-CTX2023</org_study_id>
      <nct_id>NCT05975996</nct_id>
    </id_info>
    <brief_title>Cyclophosphamide Added to Standard Immunosuppressive Therapy With Eltrombopag as Front-line Therapy in Patients With Severe Aplastic Anemia</brief_title>
    <official_title>Cyclophosphamide Added to Standard Immunosuppressive Therapy With Eltrombopag as Front-line Therapy in Patients With Severe Aplastic Anemia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institute of Hematology &amp; Blood Diseases Hospital, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institute of Hematology &amp; Blood Diseases Hospital, China</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, single-center, single-arm, phase 2 study. The aim of this study is to&#xD;
        evaluate the efficacy and safety of Anti-lymphocyte globulin plus eltrombopag in combination&#xD;
        with moderate-dose cyclophosphamide for severe aplastic anemia.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 10, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2027</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>Overall response rate</measure>
      <time_frame>Within 3 months</time_frame>
      <description>Percentage of patients with hematological response. Hematological response includes complete rate, near complete rate(CR), very good partial response(VGPR), Meaningful partial response(mPR) and partial response(PR).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Robust response</measure>
      <time_frame>Within 3 months</time_frame>
      <description>Percentage of patients with robust response, including CR, near CR, VGPR and mPR.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All-cause mortality</measure>
      <time_frame>Within 3 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to achieve robust hematological response</measure>
      <time_frame>Within 6 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of the adverse event</measure>
      <time_frame>Within 6 months</time_frame>
      <description>Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess the adverse event</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">43</enrollment>
    <condition>Severe Aplastic Anemia</condition>
    <arm_group>
      <arm_group_label>Experiemental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>ALG/CsA(Cyclosporine) + eltrombopag + moderate-dose cyclophosphamide</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cyclophosphamide added to standard immunosuppressive therapy with eltrombopag</intervention_name>
      <description>Severe aplastic anemia patients will receive a daily dose of Anti-lymphocyte globulin (25mg/kg) for the initial five days at the beginning of the treatment. Cyclosporine will be administered daily at a dosage of 3-5mg/kg. Eltrombopag will be administered daily at a dosage of 15mg starting from the first day of treatment and continuing for a duration of six months. The moderate-dose cyclophosphamide (20mg/kg) will be administered on days 29-30 and days 43-44.</description>
      <arm_group_label>Experiemental</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female age ≥ 12 years&#xD;
  &#xD;
            -  Subject has a diagnosis of naïve severe or very severe aplastic anemia&#xD;
  &#xD;
            -  ECOG performance status ≤2&#xD;
  &#xD;
            -  Unwilling or unable to receive allogeneic hematopoietic stem cell transplantation.&#xD;
  &#xD;
            -  Willing and able to comply with the requirements for this study and written informed&#xD;
               consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previously received immunosuppressive therapy &gt; 4 weeks&#xD;
  &#xD;
            -  Previously treated with TPO-RA &gt; 4 weeks&#xD;
  &#xD;
            -  Have an allergy or intolerance to either eltrombopag or cyclophosphamide.&#xD;
  &#xD;
            -  Have an allergy to ALG&#xD;
  &#xD;
            -  Uncontrolled systemic fungal, bacterial, or viral infection&#xD;
  &#xD;
            -  Poorly controlled hypertension (≥140/90mmHg) or diabetes (a fasting plasma glucose&#xD;
               concentration ≥7.0mmol/L or a random venous plasma glucose concentration ≥11.1mmol/L)&#xD;
  &#xD;
            -  Abnormal liver or kidney function: ALT or AST &gt;3 ULN, or serum creatinine (sCr)≥ 2.5&#xD;
               ULN.&#xD;
  &#xD;
            -  History of radiotherapy and chemotherapy for malignant solid tumors&#xD;
  &#xD;
            -  Combined with other serious disorders&#xD;
  &#xD;
            -  Pregnant or breast-feeding patients&#xD;
  &#xD;
            -  Patients considered to be ineligible for the study by the investigator for reasons&#xD;
               other than the above.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Liwei Fang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Institute of Hematology &amp; Blood Diseases Hospital, China</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Liwei Fang, MD</last_name>
      <phone>13752253515</phone>
      <email>fangliwei@ihcams.ac.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hong Pan, MD</last_name>
      <email>panhong@ihcams.ac.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Regenerative Medicine Center</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300131</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Liwei Fang, MD</last_name>
        <phone>13752253515</phone>
        <email>fangliwei@ihcams.ac.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Institute of Hematology &amp; Blood Diseases Hospital, China</investigator_affiliation>
      <investigator_full_name>Fang Liwei</investigator_full_name>
      <investigator_title>Associate Chief Physician of Regenerative Medical Center</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anemia</mesh_term>
      <mesh_term>Anemia, Aplastic</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cyclophosphamide</mesh_term>
      <mesh_term>Immunosuppressive Agents</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05975996
  org study id: ALG-HPAG-CTX2023
  nct id: NCT05975996
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective, single-center, single-arm, phase 2 study. The aim of this study is to
        evaluate the efficacy and safety of Anti-lymphocyte globulin plus eltrombopag in combination
        with moderate-dose cyclophosphamide for severe aplastic anemia.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Overall response rate
  time frame: Within 3 months
  description: Percentage of patients with hematological response. Hematological response includes complete rate, near complete rate(CR), very good partial response(VGPR), Meaningful partial response(mPR) and partial response(PR).
  measure: Robust response
  time frame: Within 3 months
  description: Percentage of patients with robust response, including CR, near CR, VGPR and mPR.
  measure: All-cause mortality
  time frame: Within 3 months
  measure: Time to achieve robust hematological response
  time frame: Within 6 months
  measure: Incidence of the adverse event
  time frame: Within 6 months
  description: Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess the adverse event
  arm group label: Experiemental
  arm group type: Experimental
  description: ALG/CsA(Cyclosporine) + eltrombopag + moderate-dose cyclophosphamide
  intervention type: Drug
  intervention name: Cyclophosphamide added to standard immunosuppressive therapy with eltrombopag
  description: Severe aplastic anemia patients will receive a daily dose of Anti-lymphocyte globulin (25mg/kg) for the initial five days at the beginning of the treatment. Cyclosporine will be administered daily at a dosage of 3-5mg/kg. Eltrombopag will be administered daily at a dosage of 15mg starting from the first day of treatment and continuing for a duration of six months. The moderate-dose cyclophosphamide (20mg/kg) will be administered on days 29-30 and days 43-44.
  arm group label: Experiemental
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Liwei Fang, MD
  role: Principal Investigator
  affiliation: Institute of Hematology & Blood Diseases Hospital, China
  last name: Liwei Fang, MD
  phone: 13752253515
  email: fangliwei@ihcams.ac.cn
  last name: Hong Pan, MD
  email: panhong@ihcams.ac.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Institute of Hematology & Blood Diseases Hospital, China
  investigator full name: Fang Liwei
  investigator title: Associate Chief Physician of Regenerative Medical Center
  mesh term: Anemia
  mesh term: Anemia, Aplastic
  mesh term: Cyclophosphamide
  mesh term: Immunosuppressive Agents