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/NCT06015464</url>
    </required_header>
    <id_info>
      <org_study_id>2023-SR-190</org_study_id>
      <nct_id>NCT06015464</nct_id>
    </id_info>
    <brief_title>An Ambispective Cohort Study of Orelabrutinib in Combination With Standard Treatment Regimen for Untreated DLBCL</brief_title>
    <official_title>An Ambispective Cohort Study of Orelabrutinib in Combination With Standard Treatment Regimen for Untreated DLBCL</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital with Nanjing Medical 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 retrospectively collect information on DLBCL patients treated with orelabrutinib in&#xD;
        combination with standard first-line regimens, pooled analysis of the association between&#xD;
        recent efficacy and patient characteristics (including biomarkers) in different types of&#xD;
        patients to assess the predictive value of ctDNA for prognosis and subsequent therapeutic&#xD;
        adjustments during treatment; Prospective observation to collect information on the efficacy&#xD;
        of orelabrutinib in combination with standard treatment regimens in specific types of&#xD;
        populations (with a focus on genotyped patients such as MCD, BN2 and N1 subtypes) to validate&#xD;
        the predictive value of ctDNA in diagnosis and treatment. Standard treatment regimens include&#xD;
        the R-CHOP regimen and the Pola-R-CHOP regimen.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">July 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2024</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>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>CR rate of EOT</measure>
      <time_frame>at the end of Cycle 6-8 (each cycle is 28 days)</time_frame>
      <description>CR rate at the end of treatment</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">81</enrollment>
    <condition>Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type</condition>
    <arm_group>
      <arm_group_label>prospective cohort</arm_group_label>
      <description>To retrospectively collect information on DLBCL patients treated with orelabrutinib in combination with standard first-line regimens, pooled analysis of the association between recent efficacy and patient characteristics (including biomarkers) in different types of patients to assess the predictive value of ctDNA for prognosis and subsequent therapeutic adjustments during treatment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Prospective cohort</arm_group_label>
      <description>Prospective observation to collect information on the efficacy of orelabrutinib in combination with standard treatment regimens in specific types of populations (with a focus on genotyped patients such as MCD, BN2 and N1 subtypes) to validate the predictive value of ctDNA in diagnosis and treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Orelabrutinib</intervention_name>
      <description>Addition of novel BTK inhibitor, Orelabrutinib，150 mg qd, to standard treatment regimens, which include R-CHOP and Pola-R-CHP</description>
      <arm_group_label>Prospective cohort</arm_group_label>
      <arm_group_label>prospective cohort</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Untreated Diffuse large B-cell lymphoma (DLBCL) patients&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years Diffuse large B-cell lymphoma (DLBCL) diagnosed by histopathology of&#xD;
               the tumour, without any previous anti-tumour therapy or after ≤2 cycles of&#xD;
               R-CHOP(like) or Pola-R-CHP therapy only&#xD;
  &#xD;
            -  Have a clear efficacy evaluation&#xD;
  &#xD;
            -  Patients eligible for Non-GCB or extra-nodal or dual expression or who, in the&#xD;
               judgement of the investigator, would benefit from treatment with Orelabrutinib&#xD;
               following genetic testing.&#xD;
  &#xD;
            -  Patients treated with at least 2 cycles of orelabrutinib in combination with an&#xD;
               R-CHOP(like) or Pola-R-CHP regimen&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Lymphoma involving the central nervous system or soft meningeal metastases&#xD;
  &#xD;
            -  Transforming lymphoma, i.e. from other types of lymphoma such as follicular lymphoma,&#xD;
               marginal zone lymphoma or chronic lymphocytic leukaemia or small B-cell lymphoma&#xD;
  &#xD;
            -  Primary mediastinal large B-cell lymphoma&#xD;
  &#xD;
            -  Patients with poorly controlled cardiovascular disease, infectious disease, etc.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Hematological Department, People's Hospital of Jiangsu Province</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210029</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
      <mesh_term>Neoplasms by Histologic Type</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/NCT06015464
  org study id: 2023-SR-190
  nct id: NCT06015464
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To retrospectively collect information on DLBCL patients treated with orelabrutinib in
        combination with standard first-line regimens, pooled analysis of the association between
        recent efficacy and patient characteristics (including biomarkers) in different types of
        patients to assess the predictive value of ctDNA for prognosis and subsequent therapeutic
        adjustments during treatment; Prospective observation to collect information on the efficacy
        of orelabrutinib in combination with standard treatment regimens in specific types of
        populations (with a focus on genotyped patients such as MCD, BN2 and N1 subtypes) to validate
        the predictive value of ctDNA in diagnosis and treatment. Standard treatment regimens include
        the R-CHOP regimen and the Pola-R-CHOP regimen.
  observational model: Cohort
  time perspective: Other
  measure: CR rate of EOT
  time frame: at the end of Cycle 6-8 (each cycle is 28 days)
  description: CR rate at the end of treatment
  arm group label: prospective cohort
  description: To retrospectively collect information on DLBCL patients treated with orelabrutinib in combination with standard first-line regimens, pooled analysis of the association between recent efficacy and patient characteristics (including biomarkers) in different types of patients to assess the predictive value of ctDNA for prognosis and subsequent therapeutic adjustments during treatment
  arm group label: Prospective cohort
  description: Prospective observation to collect information on the efficacy of orelabrutinib in combination with standard treatment regimens in specific types of populations (with a focus on genotyped patients such as MCD, BN2 and N1 subtypes) to validate the predictive value of ctDNA in diagnosis and treatment
  intervention type: Drug
  intervention name: Orelabrutinib
  description: Addition of novel BTK inhibitor, Orelabrutinib，150 mg qd, to standard treatment regimens, which include R-CHOP and Pola-R-CHP
  arm group label: Prospective cohort
  arm group label: prospective cohort
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Lymphoma, Large B-Cell, Diffuse
  mesh term: Neoplasms by Histologic Type
  sharing ipd: No