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/NCT05975164</url>
    </required_header>
    <id_info>
      <org_study_id>Orelabrutinib in real world</org_study_id>
      <nct_id>NCT05975164</nct_id>
    </id_info>
    <brief_title>the Real World Study of Orelabrutinib in the Treatment of CLL/SLL</brief_title>
    <official_title>A Retrospective Real-world Study of Orelabrutinib in the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shandong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shandong 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>
        This is a Multicenter, Retrospective Real-world Study of Orelabrutinib in the Treatment of&#xD;
        Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Orelabrutinib is a novel BTK inhibitor with high selectivity and has been approved in China&#xD;
        for relapsed/refractory CLL/SLL,, The purpose of this study is to describe the effectiveness&#xD;
        and safety of orelabrutinib of chronic lymphocytic leukemia (CLL) in real world.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 25, 2023</start_date>
    <completion_date type="Anticipated">July 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 10, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Overall Response Rate (ORR)</measure>
      <time_frame>up to two years</time_frame>
      <description>The ORR will be calculated as the proportion of participants who achieve either complete response (CR), partial response (PR) or partial response with lymphocytosis, as assessed by the participating physician.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to Next Therapy (TTNT)</measure>
      <time_frame>up to two years</time_frame>
      <description>The TTNT will be calculated as the difference betweenorelabrutinib initiation date and initiation date of the first next therapy for CLL</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression Free Survival (PFS)</measure>
      <time_frame>up to two years</time_frame>
      <description>PFS is defined as the duration from date of orelabrutinib initiation to date of disease progression (PD [according to the physician's evaluation]) or death from any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>response rate of Hematologic Parameters</measure>
      <time_frame>up to two years</time_frame>
      <description>the proportion of participants who had abnormal baseline hemoglobin, or platelet, or lymphocyte counts returned to normal levels or had ≥50% increases in hemoglobin and platelets or ≥50% decreases in lymphocyte counts</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>safety</measure>
      <time_frame>up to two years</time_frame>
      <description>Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations</description>
    </secondary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>CLL/SLL</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who received orelabrutinib in real world&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age ≥18 years old&#xD;
  &#xD;
            2. Patients with a definite diagnosis of CLL/SLL&#xD;
  &#xD;
            3. Prior or current use of orelabrutinib for ≥3 months&#xD;
  &#xD;
            4. At least one follow-up was recorded during orelabrutinib treatment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1.Patients who received orelabrutinib in a prospective clinical trial&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chunyan Ji, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Qilu Hospital of Shandong University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Wei Li</last_name>
      <phone>18560089739</phone>
      <email>liwei_medicine@163.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 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>Shandong University</investigator_affiliation>
      <investigator_full_name>Chunyan Ji</investigator_full_name>
      <investigator_title>Prof.</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05975164
  org study id: Orelabrutinib in real world
  nct id: NCT05975164
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a Multicenter, Retrospective Real-world Study of Orelabrutinib in the Treatment of
        Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in China
  Orelabrutinib is a novel BTK inhibitor with high selectivity and has been approved in China
        for relapsed/refractory CLL/SLL,, The purpose of this study is to describe the effectiveness
        and safety of orelabrutinib of chronic lymphocytic leukemia (CLL) in real world.
  observational model: Cohort
  time perspective: Retrospective
  measure: Overall Response Rate (ORR)
  time frame: up to two years
  description: The ORR will be calculated as the proportion of participants who achieve either complete response (CR), partial response (PR) or partial response with lymphocytosis, as assessed by the participating physician.
  measure: Time to Next Therapy (TTNT)
  time frame: up to two years
  description: The TTNT will be calculated as the difference betweenorelabrutinib initiation date and initiation date of the first next therapy for CLL
  measure: Progression Free Survival (PFS)
  time frame: up to two years
  description: PFS is defined as the duration from date of orelabrutinib initiation to date of disease progression (PD [according to the physician's evaluation]) or death from any cause
  measure: response rate of Hematologic Parameters
  time frame: up to two years
  description: the proportion of participants who had abnormal baseline hemoglobin, or platelet, or lymphocyte counts returned to normal levels or had ≥50% increases in hemoglobin and platelets or ≥50% decreases in lymphocyte counts
  measure: safety
  time frame: up to two years
  description: Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Special Situations
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Chunyan Ji, Dr.
  role: Principal Investigator
  affiliation: Qilu Hospital of Shandong University
  last name: Wei Li
  phone: 18560089739
  email: liwei_medicine@163.com
  responsible party type: Principal Investigator
  investigator affiliation: Shandong University
  investigator full name: Chunyan Ji
  investigator title: Prof.
  sharing ipd: Undecided