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/NCT05996406</url>
    </required_header>
    <id_info>
      <org_study_id>Ven-D001</org_study_id>
      <nct_id>NCT05996406</nct_id>
    </id_info>
    <brief_title>Venetoclax and Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis With Translocation (11;14)</brief_title>
    <official_title>Venetoclax Combined With Dexamethasone for Newly Diagnosed Light-Chain Amyloidosis Patients With Translocation (11;14): A Multicenter Phase 2 Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</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>
        Venetoclax is considered as a promising agent for light-chain (AL) amyloidosis due to the&#xD;
        high percentage of t(11;14). Several retrospective studies showed venetoclax-based therapy&#xD;
        could induce rapid and profound hematologic response in AL patients with favorable safety&#xD;
        profile. As an oral agent with encouraging data, it is worth to prospectively evaluate the&#xD;
        efficacy and safety of venetoclax in untreated AL amyloidosis patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 7, 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>Complete response (CR)+very good partial response (VGPR) at 3 months after treatment initiation</measure>
      <time_frame>3 months after treatment initiation</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to next treatment</measure>
      <time_frame>2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CR+VGPR at 1 month after treatment initiation</measure>
      <time_frame>1 month after treatment initiation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CR+VGPR at 6 months after treatment initiation</measure>
      <time_frame>6 months after treatment initiation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CR+VGPR at 12 months after treatment initiation</measure>
      <time_frame>12 months after treatment initiation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difference between involved and uninvolved free light chain (dFLC) &lt; 10mg/L</measure>
      <time_frame>at 1, 3, 6 and 12 months after treatment initiation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Involved free light chain (iFLC) ≤ 20mg/L</measure>
      <time_frame>at 1, 3, 6 and 12 months after treatment initiation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Minimal residual disease (MRD) negativity</measure>
      <time_frame>12 and 24 months after treatment initiation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to hematologic response</measure>
      <time_frame>1 year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to hematologic CR</measure>
      <time_frame>1 year</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cardiac response</measure>
      <time_frame>at 3, 6, 12 and 24 months after treatment initiation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Renal response</measure>
      <time_frame>at 3, 6, 12 and 24 months after treatment initiation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hepatic response</measure>
      <time_frame>at 3, 6, 12 and 24 months after treatment initiation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to cardiac response</measure>
      <time_frame>2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to renal response</measure>
      <time_frame>2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to hepatic response</measure>
      <time_frame>2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events</measure>
      <time_frame>treatment initiation to 30 days after last dose of treatment</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Light Chain (AL) Amyloidosis</condition>
    <condition>CCND1 Translocation</condition>
    <condition>Venetoclax</condition>
    <arm_group>
      <arm_group_label>Ven-D</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Venetoclax combined with dexamethasone</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Venetoclax</intervention_name>
      <description>Venetoclax 400mg po qd for 1 year</description>
      <arm_group_label>Ven-D</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexamethasone Oral</intervention_name>
      <description>Dexamethasone 40mg po qw for the first 6 months, then 10mg po qw for the next 6 months</description>
      <arm_group_label>Ven-D</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Biopsy proved treatment-naïve AL amyloidosis&#xD;
  &#xD;
            -  Fluorescence in situ hybridization (FISH) t(11;14) ≥ 10%&#xD;
  &#xD;
            -  dFLC &gt; 50mg/L&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Co-morbidity of uncontrolled infection&#xD;
  &#xD;
            -  Co-morbidity of other active malignancy&#xD;
  &#xD;
            -  Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia&#xD;
  &#xD;
            -  Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those&#xD;
               with implanted pacemaker)&#xD;
  &#xD;
            -  Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia&#xD;
  &#xD;
            -  Seropositive for human immunodeficiency virus&#xD;
  &#xD;
            -  Hepatitis B virus (HBV)-DNA &gt; 1000 copies/mL&#xD;
  &#xD;
            -  Seropositive for hepatitis C (except in the setting of a sustained virologic response)&#xD;
  &#xD;
            -  Systemic treatment with moderate or strong cytochrome P450 3A （CYP3A） inducers,&#xD;
               moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study&#xD;
               drug&#xD;
  &#xD;
            -  Neutrophil &lt;1×10E9/L，hemoglobin &lt; 8g/dL，or platelet &lt; 100×10E9/L.&#xD;
  &#xD;
            -  Severely compromised hepatic or renal function: alanine transaminase (ALT) or&#xD;
               aspertate aminotransferase (AST) &gt; 2.5 × upper limit of normal (ULN), total bilirubin&#xD;
               &gt; 3 × ULN，eGFR &lt; 15 mL/min, or receiving renal replacement therapy&#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_contact>
      <last_name>Kaini Shen, Dr.</last_name>
      <phone>+86 13693339884</phone>
      <email>shenkaini3@sina.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jian Li</last_name>
      <phone>+86 18610852525</phone>
      <email>lijian@pumch.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kaini Shen</last_name>
        <email>shenkaini3@sina.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
      <investigator_full_name>Jian Li</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Amyloidosis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dexamethasone</mesh_term>
      <mesh_term>Venetoclax</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/NCT05996406
  org study id: Ven-D001
  nct id: NCT05996406
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Venetoclax is considered as a promising agent for light-chain (AL) amyloidosis due to the
        high percentage of t(11;14). Several retrospective studies showed venetoclax-based therapy
        could induce rapid and profound hematologic response in AL patients with favorable safety
        profile. As an oral agent with encouraging data, it is worth to prospectively evaluate the
        efficacy and safety of venetoclax in untreated AL amyloidosis patients.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Complete response (CR)+very good partial response (VGPR) at 3 months after treatment initiation
  time frame: 3 months after treatment initiation
  measure: Overall survival
  time frame: 2 years
  measure: Time to next treatment
  time frame: 2 years
  measure: CR+VGPR at 1 month after treatment initiation
  time frame: 1 month after treatment initiation
  measure: CR+VGPR at 6 months after treatment initiation
  time frame: 6 months after treatment initiation
  measure: CR+VGPR at 12 months after treatment initiation
  time frame: 12 months after treatment initiation
  measure: Difference between involved and uninvolved free light chain (dFLC) < 10mg/L
  time frame: at 1, 3, 6 and 12 months after treatment initiation
  measure: Involved free light chain (iFLC) ≤ 20mg/L
  time frame: at 1, 3, 6 and 12 months after treatment initiation
  measure: Minimal residual disease (MRD) negativity
  time frame: 12 and 24 months after treatment initiation
  measure: Time to hematologic response
  time frame: 1 year
  measure: Time to hematologic CR
  time frame: 1 year
  measure: Cardiac response
  time frame: at 3, 6, 12 and 24 months after treatment initiation
  measure: Renal response
  time frame: at 3, 6, 12 and 24 months after treatment initiation
  measure: Hepatic response
  time frame: at 3, 6, 12 and 24 months after treatment initiation
  measure: Time to cardiac response
  time frame: 2 years
  measure: Time to renal response
  time frame: 2 years
  measure: Time to hepatic response
  time frame: 2 years
  measure: Adverse events
  time frame: treatment initiation to 30 days after last dose of treatment
  arm group label: Ven-D
  arm group type: Experimental
  description: Venetoclax combined with dexamethasone
  intervention type: Drug
  intervention name: Venetoclax
  description: Venetoclax 400mg po qd for 1 year
  arm group label: Ven-D
  intervention type: Drug
  intervention name: Dexamethasone Oral
  description: Dexamethasone 40mg po qw for the first 6 months, then 10mg po qw for the next 6 months
  arm group label: Ven-D
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kaini Shen, Dr.
  phone: +86 13693339884
  email: shenkaini3@sina.com
  last name: Jian Li
  phone: +86 18610852525
  email: lijian@pumch.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Peking Union Medical College Hospital
  investigator full name: Jian Li
  investigator title: Professor
  mesh term: Amyloidosis
  mesh term: Dexamethasone
  mesh term: Venetoclax