<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/NCT03801525</url>
  </required_header>
  <id_info>
    <org_study_id>U2-VEN-207</org_study_id>
    <nct_id>NCT03801525</nct_id>
  </id_info>
  <brief_title>Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax Compared to Ublituximab in Combination With Umbralisib in Subjects With CLL (ULTRA-V)</brief_title>
  <acronym>ULTRA-V</acronym>
  <official_title>Phase 2/3 Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects With Chronic Lymphocytic Leukemia (CLL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>TG Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>TG Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      ULTRA-V: Study to Assess the Efficacy and Safety of Ublituximab in Combination with&#xD;
      Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects with&#xD;
      Chronic Lymphocytic Leukemia (CLL)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, multicenter, Phase 2/3 study to evaluate the efficacy and safety of&#xD;
      the combination of ublituximab + umbralisib + venetoclax (U2-V) compared to the combination&#xD;
      of ublituximab + umbralisib (U2) in patients with either treatment naïve or previously&#xD;
      treated CLL/ small lymphocytic lymphoma (SLL)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Strategic/Business decision&#xD;
  </why_stopped>
  <start_date type="Actual">May 16, 2019</start_date>
  <completion_date type="Actual">December 20, 2022</completion_date>
  <primary_completion_date type="Actual">December 20, 2022</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 2: Complete Response (CR) Rate</measure>
    <time_frame>Up to 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Overall Response Rate</measure>
    <time_frame>Up to 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 3: Progression-Free Survival</measure>
    <time_frame>60 months</time_frame>
    <description>Progression-Free Survival in subjects treated with U2-V compared with U2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events That Are Related to Treatment</measure>
    <time_frame>6 months of therapy</time_frame>
    <description>Number of Participants With Treatment-Related Adverse Event and any potential abnormal laboratory results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3: Overall Response Rate</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Objective response in subjects treated with ublituximab + umbralisib + venetoclax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Undetectable Minimal Residual Disease (MRD)</measure>
    <time_frame>60 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Time to Response (TTR)</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Duration of Response (DOR)</measure>
    <time_frame>60 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3: Complete Response (CR) Rate</measure>
    <time_frame>Up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 3: Overall Survival (OS)</measure>
    <time_frame>72 months</time_frame>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">271</enrollment>
  <condition>Chronic Lymphocytic Leukemia</condition>
  <condition>Small Lymphocytic Lymphoma</condition>
  <arm_group>
    <arm_group_label>Phase 2: Previously Treated CLL (BTK-Not Refractory)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2: Previously Treated CLL (BTK-Refractory)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2: Treatment Naïve CLL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib (U2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib (U2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ublituximab</intervention_name>
    <description>recombinant chimeric anti-CD20 (cluster of differentiation 20) monoclonal antibody&#xD;
administered as an intravenous (IV) infusion</description>
    <arm_group_label>Phase 2: Previously Treated CLL (BTK-Not Refractory)</arm_group_label>
    <arm_group_label>Phase 2: Previously Treated CLL (BTK-Refractory)</arm_group_label>
    <arm_group_label>Phase 2: Treatment Naïve CLL</arm_group_label>
    <arm_group_label>Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib (U2)</arm_group_label>
    <arm_group_label>Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)</arm_group_label>
    <arm_group_label>Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib (U2)</arm_group_label>
    <arm_group_label>Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)</arm_group_label>
    <other_name>TG-1101</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Umbralisib</intervention_name>
    <description>inhibitor of phosphoinositide 3-kinase (PI3K) delta and casein kinase 1 epsilon (CK1e)&#xD;
Tablet form</description>
    <arm_group_label>Phase 2: Previously Treated CLL (BTK-Not Refractory)</arm_group_label>
    <arm_group_label>Phase 2: Previously Treated CLL (BTK-Refractory)</arm_group_label>
    <arm_group_label>Phase 2: Treatment Naïve CLL</arm_group_label>
    <arm_group_label>Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib (U2)</arm_group_label>
    <arm_group_label>Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)</arm_group_label>
    <arm_group_label>Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib (U2)</arm_group_label>
    <arm_group_label>Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)</arm_group_label>
    <other_name>TGR-1202</other_name>
    <other_name>UKONIQ</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Venetoclax</intervention_name>
    <description>B-cell lymphoma 2 (BCL-2) inhibitor&#xD;
Tablet form, to be taken orally</description>
    <arm_group_label>Phase 2: Previously Treated CLL (BTK-Not Refractory)</arm_group_label>
    <arm_group_label>Phase 2: Previously Treated CLL (BTK-Refractory)</arm_group_label>
    <arm_group_label>Phase 2: Treatment Naïve CLL</arm_group_label>
    <arm_group_label>Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)</arm_group_label>
    <arm_group_label>Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)</arm_group_label>
    <other_name>Venclexta®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that warrants&#xD;
             treatment&#xD;
&#xD;
          -  Adequate organ system function as specified in the protocol&#xD;
&#xD;
          -  Ability to follow protocol procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects receiving cancer therapy or any investigational drug within 21 days of Cycle&#xD;
             1, Day 1&#xD;
&#xD;
          -  Prior exposure to any PI3K inhibitor or venetoclax&#xD;
&#xD;
          -  Autologous hematologic stem cell transplant within 6 months of study entry. Prior&#xD;
             allogeneic hematologic stem cell transplant is excluded&#xD;
&#xD;
          -  Active Hepatitis B or Hepatitis C.&#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>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Stamford</city>
        <state>Connecticut</state>
        <zip>06904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Niles</city>
        <state>Illinois</state>
        <zip>60714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Site</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>37210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37916</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Blacksburg</city>
        <state>Virginia</state>
        <zip>24060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Gainesville</city>
        <state>Virginia</state>
        <zip>20155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TG Therapeutics Investigational Trial Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CLL</keyword>
  <keyword>SLL</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Data for this study will be shared after the last patient visit has been completed.</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/NCT03801525
org study id: U2-VEN-207
nct id: NCT03801525
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
ULTRA-V: Study to Assess the Efficacy and Safety of Ublituximab in Combination with
      Umbralisib and Venetoclax (U2-V) Compared to Ublituximab and Umbralisib (U2) in Subjects with
      Chronic Lymphocytic Leukemia (CLL)
This is an open-label, multicenter, Phase 2/3 study to evaluate the efficacy and safety of
      the combination of ublituximab + umbralisib + venetoclax (U2-V) compared to the combination
      of ublituximab + umbralisib (U2) in patients with either treatment naïve or previously
      treated CLL/ small lymphocytic lymphoma (SLL)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Phase 2: Complete Response (CR) Rate
time frame: Up to 12 months
measure: Phase 2: Overall Response Rate
time frame: Up to 12 months
measure: Phase 3: Progression-Free Survival
time frame: 60 months
description: Progression-Free Survival in subjects treated with U2-V compared with U2
measure: Adverse Events That Are Related to Treatment
time frame: 6 months of therapy
description: Number of Participants With Treatment-Related Adverse Event and any potential abnormal laboratory results
measure: Phase 3: Overall Response Rate
time frame: Up to 12 months
description: Objective response in subjects treated with ublituximab + umbralisib + venetoclax
measure: Rate of Undetectable Minimal Residual Disease (MRD)
time frame: 60 months
measure: Phase 2: Time to Response (TTR)
time frame: Up to 12 months
measure: Phase 2: Duration of Response (DOR)
time frame: 60 months
measure: Phase 3: Complete Response (CR) Rate
time frame: Up to 12 months
measure: Phase 3: Overall Survival (OS)
time frame: 72 months
arm group label: Phase 2: Previously Treated CLL (BTK-Not Refractory)
arm group type: Experimental
arm group label: Phase 2: Previously Treated CLL (BTK-Refractory)
arm group type: Experimental
arm group label: Phase 2: Treatment Naïve CLL
arm group type: Experimental
arm group label: Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)
arm group type: Experimental
arm group label: Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib (U2)
arm group type: Experimental
arm group label: Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)
arm group type: Experimental
arm group label: Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib (U2)
arm group type: Experimental
intervention type: Drug
intervention name: Ublituximab
description: recombinant chimeric anti-CD20 (cluster of differentiation 20) monoclonal antibody
administered as an intravenous (IV) infusion
arm group label: Phase 2: Previously Treated CLL (BTK-Not Refractory)
arm group label: Phase 2: Previously Treated CLL (BTK-Refractory)
arm group label: Phase 2: Treatment Naïve CLL
arm group label: Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib (U2)
arm group label: Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)
arm group label: Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib (U2)
arm group label: Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)
other name: TG-1101
intervention type: Drug
intervention name: Umbralisib
description: inhibitor of phosphoinositide 3-kinase (PI3K) delta and casein kinase 1 epsilon (CK1e)
Tablet form
arm group label: Phase 2: Previously Treated CLL (BTK-Not Refractory)
arm group label: Phase 2: Previously Treated CLL (BTK-Refractory)
arm group label: Phase 2: Treatment Naïve CLL
arm group label: Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib (U2)
arm group label: Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)
arm group label: Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib (U2)
arm group label: Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)
other name: TGR-1202
other name: UKONIQ
intervention type: Drug
intervention name: Venetoclax
description: B-cell lymphoma 2 (BCL-2) inhibitor
Tablet form, to be taken orally
arm group label: Phase 2: Previously Treated CLL (BTK-Not Refractory)
arm group label: Phase 2: Previously Treated CLL (BTK-Refractory)
arm group label: Phase 2: Treatment Naïve CLL
arm group label: Phase 3: Previously Treated CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)
arm group label: Phase 3: Treatment Naïve CLL/SLL: Ublituximab + Umbralisib + Venetoclax (U2-V)
other name: Venclexta®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Venetoclax
sharing ipd: Yes
ipd description: Data for this study will be shared after the last patient visit has been completed.