<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/NCT02972840</url>
  </required_header>
  <id_info>
    <org_study_id>ACE-LY-308</org_study_id>
    <secondary_id>2015-005220-26</secondary_id>
    <nct_id>NCT02972840</nct_id>
  </id_info>
  <brief_title>A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL</brief_title>
  <official_title>A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination With Acalabrutinib (ACP-196) in Subjects With Previously Untreated Mantle Cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Acerta Pharma BV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Acerta Pharma BV</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>
      This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and&#xD;
      rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle&#xD;
      cell lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR)&#xD;
      compared with placebo plus BR based on Independent Review Committee (IRC) assessment of&#xD;
      progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL)&#xD;
      in subjects with previously untreated mantle cell lymphoma (MCL).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 5, 2017</start_date>
  <completion_date type="Anticipated">October 28, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 28, 2025</primary_completion_date>
  <phase>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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2</measure>
    <time_frame>Up to 6 years</time_frame>
    <description>Defined as the time from the date of randomization until disease progression (assessed by the IRC per the Lugano Classification for NHL) or death from any cause, whichever occurs first.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Investigator-assessed progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2</measure>
    <time_frame>Up to 6 years</time_frame>
    <description>Defined as the time from the date of randomization until disease progression (assessed by the investigator per the Lugano Classification for NHL) or death from any cause, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2</measure>
    <time_frame>Up to 6 years</time_frame>
    <description>Defined as the proportion of subjects who achieve either partial response (PR) or complete response (CR) as best overall response according to the Lugano Classification for NHL as assessed by investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2</measure>
    <time_frame>Up to 6 years</time_frame>
    <description>Defined as the proportion of subjects who achieve either PR or CR as best overall response according to the Lugano Classification for NHL as assessed by IRC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival in Arm 1 compared to Arm 2</measure>
    <time_frame>Up to 6 years</time_frame>
    <description>Defined as the time from randomization until the date of death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2</measure>
    <time_frame>Up to 6 years</time_frame>
    <description>Defined as the time from the first documentation of CR or PR to disease progression per the Lugano Classification for NHL or death from any cause, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IRC assessed time to response per the Lugano Classification for NHL in Arm 1 compared to Arm 2</measure>
    <time_frame>Up to 6 years</time_frame>
    <description>Defined as the time from randomization to the first CR or PR per the Lugano Classification for NHL.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">635</enrollment>
  <condition>Lymphoma, Mantle Cell</condition>
  <arm_group>
    <arm_group_label>Acalabrutinib in combination with bendamustine and rituximab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acalabrutinib administered twice per day (BID) orally (PO) plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo in combination with bendamustine and rituximab</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acalabrutinib</intervention_name>
    <description>Administered orally (PO)</description>
    <arm_group_label>Acalabrutinib in combination with bendamustine and rituximab</arm_group_label>
    <other_name>ACP-196</other_name>
    <other_name>Calquence</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bendamustine</intervention_name>
    <description>Administered intravenously (IV)</description>
    <arm_group_label>Acalabrutinib in combination with bendamustine and rituximab</arm_group_label>
    <arm_group_label>Placebo in combination with bendamustine and rituximab</arm_group_label>
    <other_name>Treanda</other_name>
    <other_name>Bendeka</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Administered intravenously (IV)</description>
    <arm_group_label>Acalabrutinib in combination with bendamustine and rituximab</arm_group_label>
    <arm_group_label>Placebo in combination with bendamustine and rituximab</arm_group_label>
    <other_name>Rituxan</other_name>
    <other_name>Rituxan Hycela</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo comparator</description>
    <arm_group_label>Placebo in combination with bendamustine and rituximab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women, ≥ 65 years of age.&#xD;
&#xD;
          -  Pathologically confirmed MCL, with documentation of a chromosome translocation&#xD;
             t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other&#xD;
             relevant markers (eg, CD5, CD19, CD20, PAX5) .&#xD;
&#xD;
          -  MCL requiring treatment and for which no prior systemic anticancer therapies have been&#xD;
             received.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.&#xD;
&#xD;
          -  Agreement to use highly effective forms of contraception during the study and 6 months&#xD;
             after the last dose of bendamustine, or 12 months after the last dose of rituximab,&#xD;
             whichever is longest .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,&#xD;
             congestive heart failure, or myocardial infarction within 6 months of first dose of&#xD;
             study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart&#xD;
             Association Functional Classification, or corrected QT interval (QTc) &gt; 480 msec&#xD;
             (calculated using Friderica's formula: QT/RR0.33) at screening. Exception: Subjects&#xD;
             with controlled, asymptomatic atrial fibrillation during screening are allowed to&#xD;
             enroll on study.&#xD;
&#xD;
          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function,&#xD;
             resection of the stomach, extensive small bowel resection that is likely to affect&#xD;
             absorption, symptomatic inflammatory bowel disease, partial or complete bowel&#xD;
             obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.&#xD;
&#xD;
          -  Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as&#xD;
             exhibiting ongoing signs/symptoms related to the infection and without improvement,&#xD;
             despite appropriate antibiotics or other treatment), or intravenous anti infective&#xD;
             treatment within 2 weeks before first dose of study drug.&#xD;
&#xD;
          -  Concurrent participation in another therapeutic clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85719</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Downey</city>
        <state>California</state>
        <zip>90241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308-5304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905-0001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hawthorne</city>
        <state>New York</state>
        <zip>10532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fort Belvoir</city>
        <state>Virginia</state>
        <zip>22060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1114AAP</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1426ANZ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1430EGF</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1431FWO</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Caba</city>
        <zip>C1118AAT</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cordoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bedford Park</city>
        <zip>5042</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Concord</city>
        <zip>2139</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Frankston</city>
        <zip>3199</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gosford</city>
        <zip>2250</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Heidelberg</city>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Herston</city>
        <zip>QLD, 4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kogarah</city>
        <zip>NSW 2217</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Murdoch</city>
        <zip>6150</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nedlands</city>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Newcastle</city>
        <zip>2298</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Southport</city>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sydney</city>
        <zip>NSW 2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Woolloongabba</city>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Antwerpen</city>
        <zip>2060</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Roeselare</city>
        <zip>8900</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sint-Niklaas</city>
        <zip>9100</zip>
        <country>Belgium</country>
      </address>
    </facility>
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        <zip>WARD 7</zip>
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    <facility>
      <name>Research Site</name>
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        <zip>700000</zip>
        <country>Vietnam</country>
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    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>China</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hong Kong</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>New Zealand</country>
    <country>Peru</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United States</country>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bruton tyrosine kinase inhibitor</keyword>
  <keyword>Acalabrutinib</keyword>
  <keyword>Mantle Cell Lymphoma</keyword>
  <keyword>ACE-LY-308</keyword>
  <keyword>Treatment naive</keyword>
  <keyword>non-Hodgkins Lymphoma</keyword>
  <keyword>Bendomustine</keyword>
  <keyword>Rituximab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Mantle-Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Bendamustine Hydrochloride</mesh_term>
    <mesh_term>Acalabrutinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.&#xD;
All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.&#xD;
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
    <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements athttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_access_criteria>
    <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</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/NCT02972840
org study id: ACE-LY-308
secondary id: 2015-005220-26
nct id: NCT02972840
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and
      rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle
      cell lymphoma.
To evaluate the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR)
      compared with placebo plus BR based on Independent Review Committee (IRC) assessment of
      progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL)
      in subjects with previously untreated mantle cell lymphoma (MCL).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
time frame: Up to 6 years
description: Defined as the time from the date of randomization until disease progression (assessed by the IRC per the Lugano Classification for NHL) or death from any cause, whichever occurs first.
measure: Investigator-assessed progression-free survival per the Lugano Classification for NHL in Arm 1 compared to Arm 2
time frame: Up to 6 years
description: Defined as the time from the date of randomization until disease progression (assessed by the investigator per the Lugano Classification for NHL) or death from any cause, whichever occurs first.
measure: Investigator-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
time frame: Up to 6 years
description: Defined as the proportion of subjects who achieve either partial response (PR) or complete response (CR) as best overall response according to the Lugano Classification for NHL as assessed by investigator.
measure: IRC-assessed overall response rate per the Lugano Classification for NHL in Arm 1 compared to Arm 2
time frame: Up to 6 years
description: Defined as the proportion of subjects who achieve either PR or CR as best overall response according to the Lugano Classification for NHL as assessed by IRC.
measure: Overall survival in Arm 1 compared to Arm 2
time frame: Up to 6 years
description: Defined as the time from randomization until the date of death from any cause.
measure: IRC-assessed duration of response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
time frame: Up to 6 years
description: Defined as the time from the first documentation of CR or PR to disease progression per the Lugano Classification for NHL or death from any cause, whichever occurs first.
measure: IRC assessed time to response per the Lugano Classification for NHL in Arm 1 compared to Arm 2
time frame: Up to 6 years
description: Defined as the time from randomization to the first CR or PR per the Lugano Classification for NHL.
arm group label: Acalabrutinib in combination with bendamustine and rituximab
arm group type: Experimental
description: Acalabrutinib administered twice per day (BID) orally (PO) plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.
arm group label: Placebo in combination with bendamustine and rituximab
arm group type: Placebo Comparator
description: Matching placebo administered BID PO plus bendamustine on Days 1 and 2 and rituximab on Day 1; cycles are repeated every 28 days.
intervention type: Drug
intervention name: Acalabrutinib
description: Administered orally (PO)
arm group label: Acalabrutinib in combination with bendamustine and rituximab
other name: ACP-196
other name: Calquence
intervention type: Drug
intervention name: Bendamustine
description: Administered intravenously (IV)
arm group label: Acalabrutinib in combination with bendamustine and rituximab
arm group label: Placebo in combination with bendamustine and rituximab
other name: Treanda
other name: Bendeka
intervention type: Drug
intervention name: Rituximab
description: Administered intravenously (IV)
arm group label: Acalabrutinib in combination with bendamustine and rituximab
arm group label: Placebo in combination with bendamustine and rituximab
other name: Rituxan
other name: Rituxan Hycela
intervention type: Drug
intervention name: Placebo
description: Placebo comparator
arm group label: Placebo in combination with bendamustine and rituximab
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
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country: Argentina
country: Australia
country: Belgium
country: Brazil
country: Canada
country: China
country: Czechia
country: France
country: Germany
country: Greece
country: Hong Kong
country: Hungary
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Mexico
country: New Zealand
country: Peru
country: Poland
country: Romania
country: Russian Federation
country: Spain
country: Taiwan
country: Ukraine
country: United States
country: Vietnam
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Mantle-Cell
mesh term: Rituximab
mesh term: Bendamustine Hydrochloride
mesh term: Acalabrutinib
sharing ipd: Yes
ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements athttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home