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/NCT06021977</url>
    </required_header>
    <id_info>
      <org_study_id>IHBDH-IIT20230711</org_study_id>
      <nct_id>NCT06021977</nct_id>
    </id_info>
    <brief_title>The Safety and Efficacy of Zanubrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia</brief_title>
    <official_title>A Phase II, Single Center, Open-label Trial to Determine the Safety and Efficacy of Zanubrutinib in Refractory/Relapsed Autoimmune Hemolytic</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>
        The sample size of this study is calculated based on Simon's two-stage design. The first&#xD;
        stage of the study enrolled a cohort of 12 patients. If after 12 weeks at least 6 patients&#xD;
        achieved a response, then enrollment was expanded to a total of 26 patients. The null&#xD;
        hypothesis was unaccepted if more than 14 of 26 patients achieved the response. Accounting&#xD;
        for a 20% dropout rate, the estimated final sample size was 33 patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 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>Overall response rate</measure>
      <time_frame>within 12 weeks</time_frame>
      <description>The percentage of patients achieved complete response, complete response with incomplete hemolysis recovery, and partial response.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of adverse events and severe adverse events</measure>
      <time_frame>within 24 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relapse free survival rate</measure>
      <time_frame>within 48 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">33</enrollment>
    <condition>Refractory/Relapsed Autoimmune Hemolytic Anemia</condition>
    <arm_group>
      <arm_group_label>Zanubrutinib</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Each recruited subject will accept Zanubrutinib treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Zanubrutinib</intervention_name>
      <description>Zanubrutinib was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity.</description>
      <arm_group_label>Zanubrutinib</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age from 6 to 70&#xD;
  &#xD;
            -  Diagnosis of Coombs-negative AIHA&#xD;
  &#xD;
            -  Diagnosis of warm AIHA, mixed AIHA or Evans syndrome.&#xD;
  &#xD;
            -  Meets the criteria of relapsed / refractory AIHA&#xD;
  &#xD;
            -  ECOG ≤ 3&#xD;
  &#xD;
            -  Willing and able to comply with the requirements for this study and written informed&#xD;
               consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of any of the following diseases: Cold agglutinin disease, cold agglutinin&#xD;
               syndrome, mixed AIHA, paroxysmal cold hemoglobinuria (PCH).&#xD;
  &#xD;
            -  Diagnosis of active stage of connective tissue disease.&#xD;
  &#xD;
            -  History of lymphoproliferative tumors or any other malignant.&#xD;
  &#xD;
            -  Diagnosis of other inherited or acquired hemolytic diseases.&#xD;
  &#xD;
            -  Secondary AIHA caused by drugs or infection.&#xD;
  &#xD;
            -  Previously received organ or stem cell transplantation.&#xD;
  &#xD;
            -  History of thrombosis or organ infarction.&#xD;
  &#xD;
            -  Received rituximab within 8 weeks before enrollment.&#xD;
  &#xD;
            -  Previously treated with BTK inhibitor ≥ 2 weeks.&#xD;
  &#xD;
            -  Received low-molecular-weight heparin or warfarin within 1 week before enrollment and&#xD;
               need to continue the drug treatment.&#xD;
  &#xD;
            -  Received CYP3A4 Enzyme Inhibitors or Inducers within 1 week before enrollment and need&#xD;
               to continue the drug treatment.&#xD;
  &#xD;
            -  Uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing&#xD;
               signs/symptoms related to the infection without improvement despite appropriate&#xD;
               antibiotics, antiviral therapy, and/or other treatment), known human immunodeficiency&#xD;
               virus (HIV), known evidence of active infectious hepatitis B, and/or known evidence of&#xD;
               active hepatitis C.&#xD;
  &#xD;
            -  Any severe and/or uncontrolled medical conditions: refractory hypertension, clinically&#xD;
               significant cardiac diseases, renal diseases, liver diseases and metabolic diseases,&#xD;
               etc.&#xD;
  &#xD;
            -  History of mental illness.&#xD;
  &#xD;
            -  Participation in another clinical trial within 4 weeks before the start of this trial.&#xD;
  &#xD;
            -  Pregnant or breast-feeding patients.&#xD;
  &#xD;
            -  Patients considered ineligible for the study by the investigator for reasons other&#xD;
               than the above.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>70 Years</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>Weiwang Li, PhD</last_name>
      <phone>15332132036</phone>
      <email>liweiwang@ihcams.ac.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jingyu Zhao, MPH</last_name>
      <phone>13752253515</phone>
      <email>zhaojingyu@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>
      <contact>
        <last_name>Jingyu Zhao</last_name>
        <phone>13752253515</phone>
        <email>zhaojingyu94@ihcams.ac.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 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>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, Hemolytic</mesh_term>
      <mesh_term>Anemia, Hemolytic, Autoimmune</mesh_term>
      <mesh_term>Hemolysis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Zanubrutinib</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/NCT06021977
  org study id: IHBDH-IIT20230711
  nct id: NCT06021977
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The sample size of this study is calculated based on Simon's two-stage design. The first
        stage of the study enrolled a cohort of 12 patients. If after 12 weeks at least 6 patients
        achieved a response, then enrollment was expanded to a total of 26 patients. The null
        hypothesis was unaccepted if more than 14 of 26 patients achieved the response. Accounting
        for a 20% dropout rate, the estimated final sample size was 33 patients.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Overall response rate
  time frame: within 12 weeks
  description: The percentage of patients achieved complete response, complete response with incomplete hemolysis recovery, and partial response.
  measure: Incidence of adverse events and severe adverse events
  time frame: within 24 weeks
  measure: Relapse free survival rate
  time frame: within 48 weeks
  arm group label: Zanubrutinib
  arm group type: Experimental
  description: Each recruited subject will accept Zanubrutinib treatment.
  intervention type: Drug
  intervention name: Zanubrutinib
  description: Zanubrutinib was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity.
  arm group label: Zanubrutinib
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Liwei Fang, MD
  role: Principal Investigator
  affiliation: Institute of Hematology & Blood Diseases Hospital, China
  last name: Weiwang Li, PhD
  phone: 15332132036
  email: liweiwang@ihcams.ac.cn
  last name: Jingyu Zhao, MPH
  phone: 13752253515
  email: zhaojingyu@ihcams.ac.cn
  facility: 
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Institute of Hematology & Blood Diseases Hospital, China
  investigator full name: Fang Liwei
  investigator title: Physician of Regenerative Medical Center
  mesh term: Anemia
  mesh term: Anemia, Hemolytic
  mesh term: Anemia, Hemolytic, Autoimmune
  mesh term: Hemolysis
  mesh term: Zanubrutinib