<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/NCT02966756</url>
  </required_header>
  <id_info>
    <org_study_id>M14-728</org_study_id>
    <nct_id>NCT02966756</nct_id>
  </id_info>
  <brief_title>A Study of Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma</brief_title>
  <official_title>A Phase 2 Open-Label Study of the Efficacy of Venetoclax in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</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 is a Phase 2, open-label, multicenter study, evaluating the efficacy of venetoclax in&#xD;
      participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic&#xD;
      Lymphoma (SLL) either in presence of 17p deletion (Cohort 1) or those who have failed a&#xD;
      B-receptor signaling pathway inhibitor (BCRI) therapy and who have also failed, or were&#xD;
      unable to receive chemoimmunotherapy (CIT) irrespective of 17p status (Cohort 2).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 12, 2017</start_date>
  <completion_date type="Anticipated">May 30, 2029</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2029</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>Measured up to 2 years after the last participant has enrolled in the study.</time_frame>
    <description>ORR is the proportion of participants with an overall response (complete remission [CR], plus complete remission with incomplete bone marrow recovery [CRi], plus nodular partial remission [nPR], plus partial remission [PR]) per the National Cancer Institute-Working Group (NCI-WG) guidelines as assessed by the Independent Review Committee (IRC).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete Response Rate (CRR)</measure>
    <time_frame>Measured up to 2 years after the last participant has enrolled into the study.</time_frame>
    <description>CRR is defined as the proportion of subjects who achieved (CR + CRi) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (iwCLL) NCI-WG criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Overall Response (DOR)</measure>
    <time_frame>Measured up to 2 years after the last participant has enrolled into the study.</time_frame>
    <description>DOR is defined as the number of days from the date of first (CR + CRi + nPR + PR) to the earliest disease progression or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>Measured up to 5 years after the last participant has enrolled into the study.</time_frame>
    <description>PFS is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IRC) or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event Free Survival (EFS)</measure>
    <time_frame>Measured up to 5 years after the last participant has enrolled into the study.</time_frame>
    <description>EFS is defined as the number of days from the date of first dose to the date of earliest disease progression, death, or start of a new anti-leukemic therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Progression (TTP)</measure>
    <time_frame>Measured up to 5 years after the last participant has enrolled into the study.</time_frame>
    <description>TTP is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IRC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to 50% reduction in absolute lymphocyte count (ALC)</measure>
    <time_frame>Measured up to 2 years after the last participant has enrolled into the study.</time_frame>
    <description>Time to 50% reduction in ALC is defined as the number of days from the date of first dose to the date when the ALC has reduced to 50% of the baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Measured up to 5 years after the last participant has enrolled into the study.</time_frame>
    <description>OS is defined as number of days from the date of first dose to the date of death.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Chronic Lymphocytic Leukemia (CLL)</condition>
  <condition>Small Lymphocytic Lymphoma (SLL)</condition>
  <arm_group>
    <arm_group_label>Cohort 1: Venetoclax</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with 17p deletion status will receive various doses of venetoclax once daily (QD).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: Venetoclax</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who have failed a B-Cell Receptor Signaling Pathway Inhibitor (BCRI) therapy and who have also failed, or were unable to receive chemoimmunotherapy (CIT) irrespective of 17p status will receive various doses of venetoclax once daily (QD).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Venetoclax</intervention_name>
    <description>Tablet; Oral</description>
    <arm_group_label>Cohort 1: Venetoclax</arm_group_label>
    <arm_group_label>Cohort 2: Venetoclax</arm_group_label>
    <other_name>ABT-199</other_name>
    <other_name>GDC-0199</other_name>
    <other_name>Venclexta</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant must have a diagnosis of relapsed or refractory chronic lymphocytic&#xD;
             leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) that meets 2008 Modified International&#xD;
             Workshop for Chronic Lymphocytic Leukemia (iwCLL) National Cancer Institute-Working&#xD;
             Group (NCI-WG) Guidelines and the following:&#xD;
&#xD;
               -  Participant must have an indication for treatment according to the 2008 Modified&#xD;
                  iwCLL NCI-WG Guidelines.&#xD;
&#xD;
               -  SLL participant must have measurable disease (B-lymphocytosis greater than 5 ×&#xD;
                  10^9/L or an enlarged lymph node(s) (Longest Diameter (LDi) &gt; 1.5 cm at baseline)&#xD;
                  or hepatomegaly or splenomegaly due to CLL).&#xD;
&#xD;
               -  SLL participant must have presence of lymphadenopathy and absence of cytopenias&#xD;
                  caused by a clonal marrow infiltrate.&#xD;
&#xD;
               -  Participant must have relapsed or refractory CLL/SLL after receiving at least one&#xD;
                  prior line of therapy.&#xD;
&#xD;
          -  Participants (in Cohort 1) must have 17p deletion, assessed by a central laboratory.&#xD;
&#xD;
          -  Participants (in Cohort 2) must meet both of the following:&#xD;
&#xD;
               -  Relapsed/refractory disease to B-Cell Receptor Signaling Pathway Inhibitor (BCRI)&#xD;
                  treatment;&#xD;
&#xD;
               -  And either of the following: (a) relapsed/refractory disease to&#xD;
                  chemoimmunotherapy (CIT), or (b) ineligible to receive CIT, defined as having&#xD;
                  known 17p deletion or TP53 mutation, or Cumulative Illness Rating Scale (CIRS) &gt;6&#xD;
                  or calculated creatinine clearance &lt;70 mL/min, or participants in whom the&#xD;
                  investigator evaluated that the use of CIT was inappropriate.&#xD;
&#xD;
          -  Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score&#xD;
             of less than or equal to 2.&#xD;
&#xD;
          -  Participant must have adequate bone marrow function, coagulation profile, renal, and&#xD;
             hepatic function, per laboratory reference range at Screening.&#xD;
&#xD;
          -  No known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)&#xD;
             infection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has undergone an allogeneic stem cell transplant.&#xD;
&#xD;
          -  Participant has developed Richter's transformation confirmed by biopsy.&#xD;
&#xD;
          -  Participant has prolymphocytic leukemia.&#xD;
&#xD;
          -  Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to&#xD;
             screening), including autoimmune hemolytic anemia (AIHA) and idiopathic&#xD;
             thrombocytopenic purpura (ITP).&#xD;
&#xD;
          -  Participant has previously received venetoclax.&#xD;
&#xD;
          -  Participant is known to be positive for Human Immunodeficiency Virus (HIV).&#xD;
&#xD;
          -  Participant has received a biologic agent for anti-neoplastic intent within 30 days&#xD;
             prior to the first dose of study drug.&#xD;
&#xD;
          -  Participant has received any of the following within 14 days or 5 half-lives&#xD;
             (whichever is shorter) prior to the first dose of venetoclax, or has not recovered to&#xD;
             less than Common Toxicity Criteria for Adverse Events (CTCAE) grade 2 clinically&#xD;
             significant adverse effect(s)/toxicity(s) of the previous therapy:&#xD;
&#xD;
               -  Any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy or&#xD;
                  targeted small molecule agents.&#xD;
&#xD;
               -  Investigational therapy, including targeted small molecule agents.&#xD;
&#xD;
          -  Participant has known allergy to both xanthine oxidase inhibitors and rasburicase.&#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>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ABBVIE CALL CENTER</last_name>
    <phone>844-663-3742</phone>
    <email>abbvieclinicaltrials@abbvie.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Concord Repatriation General Hospital /ID# 201261</name>
      <address>
        <city>Concord</city>
        <state>New South Wales</state>
        <zip>2139</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St George Hospital /ID# 206484</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre /ID# 201263</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Anhui Provincial Cancer Hospital /ID# 209458</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230031</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Peking University People's Hospital /ID# 156575</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital /ID# 156576</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fujian Medical University Union Hospital /ID# 156579</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Guangdong Provincial People's Hospital /ID# 160509</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nanfang Hospital of Southern Medical University /ID# 156571</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Hebei Medical University /ID# 159143</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital /ID# 156573</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital Tongji Medical College of HUST /ID# 156589</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital Central South University /ID# 208913</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital /ID# 156577</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Soochow University /ID# 156536</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Nanchang University /ID# 159142</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University /ID# 156532</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shandong Provincial Hospital /ID# 156574</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 156572</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200065</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University /ID# 156537</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institute of Hematology &amp; Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 157762</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute &amp; Hospital /ID# 156542</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 156578</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The General Hospital of Western Theater Command PLA /ID# 159145</name>
      <address>
        <city>Chengdu</city>
        <zip>610083</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>North Shore Hospital /ID# 204637</name>
      <address>
        <city>Takapuna</city>
        <state>Auckland</state>
        <zip>0622</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Christchurch Hospital /ID# 201650</name>
      <address>
        <city>Christchurch</city>
        <state>Canterbury</state>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Changhua Christian Hospital /ID# 202768</name>
      <address>
        <city>Changhua City, Changhua County</city>
        <zip>50006</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 202765</name>
      <address>
        <city>Kaohsiung</city>
        <zip>807</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital /ID# 202767</name>
      <address>
        <city>Taichung</city>
        <zip>40447</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital /ID# 210733</name>
      <address>
        <city>Taipei City</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Linkou Chang Gung Memorial Hospital /ID# 203636</name>
      <address>
        <city>Taoyuan City</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>China</country>
    <country>New Zealand</country>
    <country>Taiwan</country>
  </location_countries>
  <link>
    <url>https://www.abbvieclinicaltrials.com/study/?id=M14-728</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Relapsed chronic lymphocytic leukemia (CLL)</keyword>
  <keyword>Refractory chronic lymphocytic leukemia (CLL)</keyword>
  <keyword>17p deletion</keyword>
  <keyword>Venetoclax</keyword>
  <keyword>Leukemia</keyword>
  <keyword>Lymphoproliferative Disorders</keyword>
  <keyword>Small Lymphocytic Lymphoma (SLL)</keyword>
  <keyword>Venclexta</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Venetoclax</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/abbvie/</ipd_url>
  </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/NCT02966756
org study id: M14-728
nct id: NCT02966756
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a Phase 2, open-label, multicenter study, evaluating the efficacy of venetoclax in
      participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic
      Lymphoma (SLL) either in presence of 17p deletion (Cohort 1) or those who have failed a
      B-receptor signaling pathway inhibitor (BCRI) therapy and who have also failed, or were
      unable to receive chemoimmunotherapy (CIT) irrespective of 17p status (Cohort 2).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate (ORR)
time frame: Measured up to 2 years after the last participant has enrolled in the study.
description: ORR is the proportion of participants with an overall response (complete remission [CR], plus complete remission with incomplete bone marrow recovery [CRi], plus nodular partial remission [nPR], plus partial remission [PR]) per the National Cancer Institute-Working Group (NCI-WG) guidelines as assessed by the Independent Review Committee (IRC).
measure: Complete Response Rate (CRR)
time frame: Measured up to 2 years after the last participant has enrolled into the study.
description: CRR is defined as the proportion of subjects who achieved (CR + CRi) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (iwCLL) NCI-WG criteria.
measure: Duration of Overall Response (DOR)
time frame: Measured up to 2 years after the last participant has enrolled into the study.
description: DOR is defined as the number of days from the date of first (CR + CRi + nPR + PR) to the earliest disease progression or death
measure: Progression Free Survival (PFS)
time frame: Measured up to 5 years after the last participant has enrolled into the study.
description: PFS is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IRC) or death.
measure: Event Free Survival (EFS)
time frame: Measured up to 5 years after the last participant has enrolled into the study.
description: EFS is defined as the number of days from the date of first dose to the date of earliest disease progression, death, or start of a new anti-leukemic therapy.
measure: Time to Progression (TTP)
time frame: Measured up to 5 years after the last participant has enrolled into the study.
description: TTP is defined as the number of days from the date of first dose to the date of earliest disease progression (determined by the IRC).
measure: Time to 50% reduction in absolute lymphocyte count (ALC)
time frame: Measured up to 2 years after the last participant has enrolled into the study.
description: Time to 50% reduction in ALC is defined as the number of days from the date of first dose to the date when the ALC has reduced to 50% of the baseline value.
measure: Overall Survival (OS)
time frame: Measured up to 5 years after the last participant has enrolled into the study.
description: OS is defined as number of days from the date of first dose to the date of death.
arm group label: Cohort 1: Venetoclax
arm group type: Experimental
description: Participants with 17p deletion status will receive various doses of venetoclax once daily (QD).
arm group label: Cohort 2: Venetoclax
arm group type: Experimental
description: Participants who have failed a B-Cell Receptor Signaling Pathway Inhibitor (BCRI) therapy and who have also failed, or were unable to receive chemoimmunotherapy (CIT) irrespective of 17p status will receive various doses of venetoclax once daily (QD).
intervention type: Drug
intervention name: Venetoclax
description: Tablet; Oral
arm group label: Cohort 1: Venetoclax
arm group label: Cohort 2: Venetoclax
other name: ABT-199
other name: GDC-0199
other name: Venclexta
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
last name: ABBVIE CALL CENTER
phone: 844-663-3742
email: abbvieclinicaltrials@abbvie.com
facility: 
status: Recruiting
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status: Completed
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status: Recruiting
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status: Completed
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status: Recruiting
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status: Recruiting
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status: Recruiting
country: Australia
country: China
country: New Zealand
country: Taiwan
url: https://www.abbvieclinicaltrials.com/study/?id=M14-728
description: Related Info
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Venetoclax
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
ipd url: https://vivli.org/ourmember/abbvie/