<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/NCT04419519</url>
  </required_header>
  <id_info>
    <org_study_id>19-395</org_study_id>
    <nct_id>NCT04419519</nct_id>
  </id_info>
  <brief_title>Assessing Minimal Residual Disease by Next- Generation Sequencing to Minimize Exposure in People With CLL or SLL Who Have Been Treated With Venetoclax</brief_title>
  <official_title>Veneto-STOP Study: Sequential Assessment of Minimal Residual Disease by Next Generation Sequencing to Optimize Outcomes and Minimize Exposure in Venetoclax-Treated CLL/SLL Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Adaptive Biotechnologies</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will find out whether people with CLL or SLL who have received treatment with&#xD;
      venetoclax, either alone or in combination with another drug, and who are found to be&#xD;
      MRD-negative, can stop treatment with venetoclax and remain off-treatment for 12 months or&#xD;
      more. The researchers will also see whether study participants remain MRD-negative after they&#xD;
      stop treatment with venetoclax.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Screening Phase:&#xD;
&#xD;
      Patients will be identified by clinical investigators at participating centers. Patients who&#xD;
      sign the screening consent will undergo MRD assessment with the clonoSEQ® assay. If the&#xD;
      assessment identifies the patient to be MRD negative, the patient will undergo a repeat MRD&#xD;
      assessment ≥ 28 days later. If two consecutive MRD assessments indicate MRD-negativity, the&#xD;
      patient will then sign the study intervention phase informed consent form and will undergo&#xD;
      the rest of the screening process.&#xD;
&#xD;
      Enrollment&#xD;
&#xD;
      Once the patient fulfills all eligibility criteria, the patient will be enrolled into one of&#xD;
      two cohorts based on the type of therapy they are receiving at the time of enrolled:&#xD;
&#xD;
      Cohort A: Venetoclax monotherapy at time of enrollment.&#xD;
&#xD;
      Cohort B: Venetoclax with anti CD20 monoclonal antibody at time of enrollment (The latter&#xD;
      includes patients who initiated anti CD20 monoclonal antibody with venetoclax and have since&#xD;
      completed the anti CD20 monoclonal antibody portion of the regimen.)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 13, 2020</start_date>
  <completion_date type="Anticipated">May 2025</completion_date>
  <primary_completion_date type="Anticipated">May 2025</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a multicenter clinical stopping trial for venetoclax-treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients able to remain off CLL/SLL directed therapy</measure>
    <time_frame>2 years</time_frame>
    <description>This will be described as a percentage of all patients with available data at 12 cycles of follow up (evaluable population).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Chronic Lymphocytic Leukemia (CLL)</condition>
  <condition>Small Lymphocytic Lymphoma (SLL)</condition>
  <arm_group>
    <arm_group_label>Venetoclax monotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Venetoclax with anti-CD20 monoclonal antibody</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Venetoclax monotherapy</intervention_name>
    <description>Venetoclax monotherapy</description>
    <arm_group_label>Venetoclax monotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Venetoclax with anti CD20 monoclonal antibody</intervention_name>
    <description>Venetoclax with anti CD20 monoclonal antibody</description>
    <arm_group_label>Venetoclax with anti-CD20 monoclonal antibody</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Screening Phase Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18-years-old&#xD;
&#xD;
          -  Diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma confirmed by&#xD;
             the enrolling institution&#xD;
&#xD;
          -  Receiving treatment or planning to receive treatment within 30 days with a&#xD;
             venetoclax-based regimen as defined below:&#xD;
&#xD;
               -  Venetoclax monotherapy&#xD;
&#xD;
               -  Venetoclax in combination with anti CD20 monoclonal antibody (Patients must have&#xD;
                  completed the anti CD20 monoclonal antibody portion of the regimen prior to&#xD;
                  discontinuing therapy)&#xD;
&#xD;
          -  Patient has or will have specimen to identify the CLL or SLL clone(s) for future MRD&#xD;
             assessments by clonoSEQ® defined as any of the following:&#xD;
&#xD;
               -  3-5 bone marrow aspirate slides (banked), 3-5 FFPE slides (banked), banked tumor&#xD;
                  cells or banked DNA collected from the patient at any time from original&#xD;
                  diagnosis of CLL or SLL to present&#xD;
&#xD;
               -  Peripheral blood, marrow, or lymph node involvement for fresh sample collection&#xD;
&#xD;
          -  The screening ID sample (high disease burden sample) can be sent prior to start of&#xD;
             venetoclax-based therapy to identify the clone for tracking.&#xD;
&#xD;
        Study Intervention Phase Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have received venetoclax-based therapy for at least 6 months (including&#xD;
             dose interruptions)&#xD;
&#xD;
          -  If receiving venetoclax in combination with anti-CD20 monoclonal antibody, patients&#xD;
             must have completed or discontinued the anti CD20 monoclonal antibody portion of the&#xD;
             regimen prior to discontinuing therapy&#xD;
&#xD;
          -  Patients must have two MRD-negative assessments (defined by ≥ 10^-5 sensitivity) on&#xD;
             the peripheral blood by the clonoSEQ® assay at least 28 days apart. Given that MRD&#xD;
             status is a dynamic endpoint which may improve with time, if a patient is screen&#xD;
             failure based on MRD status (i.e. MRD positive at the 10-5 sensitivity), they may be&#xD;
             rescreened to assess for study eligibility.&#xD;
&#xD;
          -  Patients must have achieved a complete or partial remission with the venetoclax-based&#xD;
             regimen. Criteria for remission are per iwCLL 2018 guidelines. For this protocol, bone&#xD;
             marrow biopsy/aspirate evaluation is not necessary to determine remission status.&#xD;
&#xD;
        Exclusion Criteria (both study phases):&#xD;
&#xD;
          -  Ongoing participation in a clinical trial that supplies venetoclax and/or anti CD20&#xD;
             monoclonal antibody&#xD;
&#xD;
          -  Unwilling or unable to participate in all required study evaluations and procedures.&#xD;
&#xD;
          -  Unable to understand the purpose and risks of the study and to provide a signed and&#xD;
             dated informed consent form (ICF) and authorization to use protected health&#xD;
             information (in accordance with national and local patient privacy regulations).&#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>Lindsey Roeker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lindsey Roeker, MD</last_name>
    <phone>646-608-4115</phone>
    <email>roekerl@mskcc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mark Geyer, MD</last_name>
    <phone>646-608-3745</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge (All protocol activities)</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lindsey Roeker, MD</last_name>
      <phone>646-608-4115</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth (All protocol activities)</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lindsey Roeker, MD</last_name>
      <phone>646-608-4115</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Bergen (All protocol activities)</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lindsey Roeker, MD</last_name>
      <phone>646-608-4115</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Commack (All protocol activities)</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lindsey Roeker, MD</last_name>
      <phone>646-608-4115</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester (All protocol activities)</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lindsey Roeker, MD</last_name>
      <phone>646-608-4115</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicole Lamanna, MD</last_name>
      <phone>212-305-5098</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center (All Protocol Activities)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lindsey Roeker, MD</last_name>
      <phone>646-608-4115</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau (All protocol activities)</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lindsey Roeker, MD</last_name>
      <phone>646-608-4115</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chaitra Ujjani, MD</last_name>
      <phone>855-557-0555</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Venetoclax</keyword>
  <keyword>Anti-CD20 monoclonal antibody</keyword>
  <keyword>19-395</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
    <mesh_term>Neoplasm, Residual</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Venetoclax</mesh_term>
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04419519
org study id: 19-395
nct id: NCT04419519
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study will find out whether people with CLL or SLL who have received treatment with
      venetoclax, either alone or in combination with another drug, and who are found to be
      MRD-negative, can stop treatment with venetoclax and remain off-treatment for 12 months or
      more. The researchers will also see whether study participants remain MRD-negative after they
      stop treatment with venetoclax.
Screening Phase:

      Patients will be identified by clinical investigators at participating centers. Patients who
      sign the screening consent will undergo MRD assessment with the clonoSEQ® assay. If the
      assessment identifies the patient to be MRD negative, the patient will undergo a repeat MRD
      assessment ≥ 28 days later. If two consecutive MRD assessments indicate MRD-negativity, the
      patient will then sign the study intervention phase informed consent form and will undergo
      the rest of the screening process.

      Enrollment

      Once the patient fulfills all eligibility criteria, the patient will be enrolled into one of
      two cohorts based on the type of therapy they are receiving at the time of enrolled:

      Cohort A: Venetoclax monotherapy at time of enrollment.

      Cohort B: Venetoclax with anti CD20 monoclonal antibody at time of enrollment (The latter
      includes patients who initiated anti CD20 monoclonal antibody with venetoclax and have since
      completed the anti CD20 monoclonal antibody portion of the regimen.)
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This is a multicenter clinical stopping trial for venetoclax-treated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients.
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of patients able to remain off CLL/SLL directed therapy
time frame: 2 years
description: This will be described as a percentage of all patients with available data at 12 cycles of follow up (evaluable population).
arm group label: Venetoclax monotherapy
arm group type: Experimental
arm group label: Venetoclax with anti-CD20 monoclonal antibody
arm group type: Experimental
intervention type: Drug
intervention name: Venetoclax monotherapy
description: Venetoclax monotherapy
arm group label: Venetoclax monotherapy
intervention type: Drug
intervention name: Venetoclax with anti CD20 monoclonal antibody
description: Venetoclax with anti CD20 monoclonal antibody
arm group label: Venetoclax with anti-CD20 monoclonal antibody
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lindsey Roeker, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: Lindsey Roeker, MD
phone: 646-608-4115
email: roekerl@mskcc.org
last name: Mark Geyer, MD
phone: 646-608-3745
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Neoplasm, Residual
mesh term: Venetoclax
mesh term: Antibodies
mesh term: Antibodies, Monoclonal
sharing ipd: Yes
ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.