<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/NCT03816683</url>
  </required_header>
  <id_info>
    <org_study_id>D8220R00004</org_study_id>
    <nct_id>NCT03816683</nct_id>
  </id_info>
  <brief_title>A Disease Registry of Patients With Mantle Cell Lymphoma</brief_title>
  <acronym>SUMMIT</acronym>
  <official_title>Treatment Patterns, Outcomes, and Patient-Reported Health-Related Quality of Life: A Prospective Disease Registry of Patients With Mantle Cell Lymphoma Treated With Novel Agents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to create a patient registry in order to assess treatment&#xD;
      patterns, physician reported clinical outcomes and patient-reported health-related quality of&#xD;
      life among patients diagnosed with Mantle Cell Lymphoma (MCL) who newly initiated a novel&#xD;
      therapy in the past 6 months and whose treatment is ongoing at the time of enrollment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Newer targeted therapies (monotherapy or in combination with other agents) have been recently&#xD;
      approved in the United States for the treatment of adult patients with mantle cell lymphoma&#xD;
      (MCL) who have received at least 1 prior therapy. The approval of these newer therapies will&#xD;
      have an impact on the treatment patterns, toxicity patterns, and outcomes in the MCL&#xD;
      population. A prospective, observational study will help to better understand the evolving&#xD;
      real-world treatment outcomes (including treatment patterns, reasons for discontinuation/dose&#xD;
      reduction, treatment interruption or treatment switches), physician-reported clinical&#xD;
      outcomes, and patient-reported symptoms and health-related quality of life (HRQoL) among&#xD;
      patients diagnosed with Mantle Cell Lymphoma (MCL) who newly initiated a novel therapy in the&#xD;
      past 6 months and whose treatment is ongoing at the time of enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The frequency and proportion of patients exposed to each novel agent therapy</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>MCL novel agent treatment types are part of the primary study objective relating to treatment patterns and will be descriptive only and use aggregated patient data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The frequency and proportion of patients exposed to novel agent by therapy regimen</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>MCL treatment regimens are part of the primary study objective relating to treatment patterns and will be descriptive only and use aggregated patient data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The frequency and proportion of patients exposed to novel agent by line of therapy</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>MCL treatment line is part of the primary study objective relating to treatment patterns and will be descriptive only and use aggregated patient data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The frequency and proportion of patients exposed to novel agent by therapy class</measure>
    <time_frame>24 to 60 months.</time_frame>
    <description>MCL treatment class is part of the primary study objective relating to treatment patterns and will be descriptive only and use aggregated patient data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The rate of patients who change novel agent therapy dose (in months)</measure>
    <time_frame>24 to 60 months.</time_frame>
    <description>Summarizing MCL novel agent treatment dose changes are part of the primary study objective relating to treatment patterns and will be descriptive only. Time-to-dose change will be assessed. The rate of dose modification (in months) will be estimated using aggregated patient data. Summary statistics (mean, SD, median, IQR, minimum, and maximum) will be used to describe time on a particular dose, which will be measured from the start of treatment until the date of dose change or death.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The rate of patients who interrupt novel agent therapy (in months)</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>Summarizing MCL treatment interruptions are part of the primary study objective relating to treatment patterns and will be descriptive only. The rate of treatment interruption (in months) will be estimated using aggregated patient data. Summary statistics (mean, SD, median, IQR, minimum, and maximum) will be used to describe time on therapy, which will be measured from the start of treatment until the date of interruption or death.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The rate of patients who discontinue novel agent therapy (in months)</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>Summarizing MCL treatment discontinuations are part of the primary study objective relating to treatment patterns and will be descriptive only. The rate of treatment discontinuation (in months) will be estimated using aggregated patient data. Reasons for discontinuations will be collected and summarized categorically. Summary statistics (mean, SD, median, IQR, minimum, and maximum) will be used to describe time on therapy, which will be measured from the start of treatment until the date of discontinuation or death.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The duration of MCL treatment</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>Summarizing MCL treatment duration is part of the primary study objective relating to treatment patterns and will be descriptive only. The duration and number of cycles of each targeted treatment (mean, SD, median, IQR, minimum, and maximum) will be summarized. Summary statistics (mean, SD, median, IQR, minimum, and maximum) will be used to describe time on therapy (in months), which will be measured from the start of treatment until the date of discontinuation, interruption, switch or death.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimate the overall response rate (ORR) among patients diagnosed with MCL and initiating treatment with novel therapies</measure>
    <time_frame>24 to 60 months.</time_frame>
    <description>ORR will be measured as the frequency and proportion of patients with a complete or partial response based on physician assessment during the observation period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimate the complete response rate (CR) among patients diagnosed with MCL and initiating treatment with novel therapies.</measure>
    <time_frame>24 to 60 months.</time_frame>
    <description>The CR will be calculated as the frequency and proportion of patients with a complete response based on physician assessment during the observation period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimate progression-free survival (PFS) among patients diagnosed with MCL and initiating treatment with novel therapies.</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>All survival outcome measures will be descriptive only. PFS will be calculated as the time from the start of novel MCL treatment until progression or death. Summary statistics (mean, median, SD, IQR, minimum and maximum) will be used to describe PFS. Kaplan-Meier curves will be used to graphically show PFS.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimate event-free survival (EFS) among patients diagnosed with MCL and initiating treatment with novel therapies.</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>All survival outcome measures will be descriptive only. EFS will be calculated as the time from the start of novel MCL treatment to disease progression, death, or discontinuation of treatment for any reason (eg, toxicity, patient preference, or initiation of a new treatment without documented progression).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimate overall survival (OS) among patients diagnosed with MCL and initiating treatment with novel therapies.</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>All survival outcome measures will be descriptive only. OS will be captured using summary statistics (mean, SD, median, IQR, minimum and maximum), which will be used to describe time from diagnosis to death, time from enrollment to death, time from index novel MCL treatment to death and time from second treatment (if applicable) to death. Kaplan-Meier curves will be used to graphically show patient survival.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The frequency of adverse events (AEs) in patients with MCL, where the term AE is used to include both serious and non-serious AEs.</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>The frequency of patients with AEs will be tabulated from the start of index novel MCL treatment. AEs (both in terms of the MedDRA Preferred Terms (PTs) and Common Terminology Criteria for Adverse Events [CTCAE] grade) will be listed individually by patient and described by System Organ Class (SOC) and PT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of adverse events (AEs) in patients with MCL, where the term AE is used to include both serious and non-serious AEs.</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>The proportion of patients with AEs will be calculated from the start of index novel MCL treatment. AEs (both in terms of the MedDRA Preferred Terms (PTs) and Common Terminology Criteria for Adverse Events [CTCAE] grade) will be listed individually by patient and described by System Organ Class (SOC) and PT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate the frequency of serious adverse events (SAEs) in patients with MCL</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>The proportion and frequency patients with SAEs will be tabulated from the start of index novel MCL treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate the frequency of reported serious adverse safety events and adverse events leading to treatment changes associated with novel agents in patients with MCL</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>The proportion and frequency of all SAEs and any AEs leading to treatment changes will be tabulated overall, and will also include the frequency and proportion of: (1) drug discontinuations, (2) dose interruptions or (3) dose changes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate the frequency and proportion of patients experiencing a clinical event of interest (related to MCL or MCL treatment)</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>The clinical events of interest that have an economic impact will be tabulated with the frequency and proportion of patients experiencing the event. Medical interventions used for managing clinical events of interest including but not limited to: diagnostic tests, procedures and medications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimate the frequency and proportion of patients experiencing healthcare resource utilization (HCRU), such as inpatient or emergency department visits</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>Each type of physician visit will be tabulated at the aggregate level using the mean, SD, median, IQR, minimum and maximum. The total number of visits across all facilities will also be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tabulate HRQoL responses for the validated EORTC QLC-C30 Patient Reported Outcome (PRO) in patients with MCL</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>Descriptive statistics for each validated PRO will include continuous measures (mean, median, SD, IQR, minimum, and maximum) or achievement of a particular threshold (frequency and proportion), if applicable. This study will collect patient perceptions of HRQoL based on PRO measures in patients with MCL by collecting the European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) on a quarterly basis. The EORTC QLQ-C30 has a recall/observation period during the past week. The questionnaire uses a 4-point Likert scale ranging from 1: &quot;Not at all&quot; to 4: &quot;Very much,&quot; and scores by dimension range from 0 to 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tabulate HRQoL responses for the three selected, validated PRO-CTCAE PRO measures in patients with MCL</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>Descriptive statistics for each validated PRO will include continuous measures (mean, median, SD, IQR, minimum, and maximum) or achievement of a particular threshold (frequency and proportion), if applicable. This study will collect patient perceptions of HRQoL by collecting the PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) (3 questions regarding muscle pain, joint pain, heart palpitations) on a quarterly basis. The PRO-CTCAE is intended for individuals 18 years or older and has a recall of the past 7 days. Responses to each question are scored from 0 to 4 (in order of increasing frequency and severity).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tabulate HRQoL responses for the validated PRO EuroQoL 5-Dimension 5-Level (EQ-5D-5L) in patients with MCL</measure>
    <time_frame>24 to 60 months</time_frame>
    <description>Descriptive statistics for each validated PRO will include continuous measures (mean, median, SD, IQR, minimum, and maximum) or achievement of a particular threshold (frequency and proportion), if applicable. This study will collect patient perceptions of HRQoL based on PRO measures in patients with MCL by collecting the EQ-5D-5L on a quarterly basis. This questionnaire is comprised of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and 1 visual analog scale used to assess a patient's self-rated health. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A unique health state is defined by combining 1 level from each of the 5 dimensions. Each health state is referred to in terms of a 5-digit code.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">231</enrollment>
  <condition>Mantle Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>Single cohort (registry) of MCL patients</arm_group_label>
    <description>Patients diagnosed with MCL who have initiated a novel therapy meeting inclusion/exclusion criteria in the past 6 months and treatment is ongoing at the time of enrollment.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with a diagnosis of MCL who have received any line of novel MCL treatment&#xD;
        within the past 6 months (and treatment is ongoing at the time of enrollment).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient diagnosed with Mantle Cell Lymphoma (MCL)&#xD;
&#xD;
          -  Informed consent for participation&#xD;
&#xD;
          -  Age ≥ 18 years old, as of the first observed diagnosis of MCL&#xD;
&#xD;
          -  Patients for whom a clinical decision has been made to initiate novel therapy in the&#xD;
             last 6 months, limited to the following novel agent categories:&#xD;
&#xD;
               -  Bcl-2 inhibitors&#xD;
&#xD;
               -  BTK inhibitors&#xD;
&#xD;
               -  Immunomodulatory agents&#xD;
&#xD;
               -  Phosphoinositide 3-kinase inhibitors The novel agent must have been granted&#xD;
                  approval in at least one haematological cancer. Treatment must be ongoing at the&#xD;
                  time of enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Patient is participating in a clinical study that prohibits participation in&#xD;
        non-interventional studies, or where treatment is blinded, at the time of consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Hermann</last_name>
    <role>Study Director</role>
    <affiliation>Senior Medical Director, Haematology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montgomery</city>
        <state>Alabama</state>
        <zip>36101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Clovis</city>
        <state>California</state>
        <zip>93611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80303-1385</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612-9497</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20852</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>Duluth</city>
        <state>Minnesota</state>
        <zip>55805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berkeley Heights</city>
        <state>New Jersey</state>
        <zip>07922</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>East Syracuse</city>
        <state>New York</state>
        <zip>13057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bend</city>
        <state>Oregon</state>
        <zip>97701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401-8122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</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>Lubbock</city>
        <state>Texas</state>
        <zip>79410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</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>Seattle</city>
        <state>Washington</state>
        <zip>98195-9472</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>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ahn IE, Farooqui MZH, Tian X, Valdez J, Sun C, Soto S, Lotter J, Housel S, Stetler-Stevenson M, Yuan CM, Maric I, Calvo KR, Nierman P, Hughes TE, Saba NS, Marti GE, Pittaluga S, Herman SEM, Niemann CU, Pedersen LB, Geisler CH, Childs R, Aue G, Wiestner A. Depth and durability of response to ibrutinib in CLL: 5-year follow-up of a phase 2 study. Blood. 2018 May 24;131(21):2357-2366. doi: 10.1182/blood-2017-12-820910. Epub 2018 Feb 26.</citation>
    <PMID>29483101</PMID>
  </reference>
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  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mantle Cell Lymphoma</keyword>
  <keyword>Registry</keyword>
  <keyword>MCL novel therapy</keyword>
  <keyword>MCL treatment patterns</keyword>
  <keyword>MCL reported outcomes</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>
  <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:&#xD;
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_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&#xD;
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 deidentified 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 at&#xD;
https://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/NCT03816683
org study id: D8220R00004
nct id: NCT03816683
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to create a patient registry in order to assess treatment
      patterns, physician reported clinical outcomes and patient-reported health-related quality of
      life among patients diagnosed with Mantle Cell Lymphoma (MCL) who newly initiated a novel
      therapy in the past 6 months and whose treatment is ongoing at the time of enrollment.
Newer targeted therapies (monotherapy or in combination with other agents) have been recently
      approved in the United States for the treatment of adult patients with mantle cell lymphoma
      (MCL) who have received at least 1 prior therapy. The approval of these newer therapies will
      have an impact on the treatment patterns, toxicity patterns, and outcomes in the MCL
      population. A prospective, observational study will help to better understand the evolving
      real-world treatment outcomes (including treatment patterns, reasons for discontinuation/dose
      reduction, treatment interruption or treatment switches), physician-reported clinical
      outcomes, and patient-reported symptoms and health-related quality of life (HRQoL) among
      patients diagnosed with Mantle Cell Lymphoma (MCL) who newly initiated a novel therapy in the
      past 6 months and whose treatment is ongoing at the time of enrollment.
observational model: Cohort
time perspective: Prospective
measure: The frequency and proportion of patients exposed to each novel agent therapy
time frame: 24 to 60 months
description: MCL novel agent treatment types are part of the primary study objective relating to treatment patterns and will be descriptive only and use aggregated patient data.
measure: The frequency and proportion of patients exposed to novel agent by therapy regimen
time frame: 24 to 60 months
description: MCL treatment regimens are part of the primary study objective relating to treatment patterns and will be descriptive only and use aggregated patient data.
measure: The frequency and proportion of patients exposed to novel agent by line of therapy
time frame: 24 to 60 months
description: MCL treatment line is part of the primary study objective relating to treatment patterns and will be descriptive only and use aggregated patient data.
measure: The frequency and proportion of patients exposed to novel agent by therapy class
time frame: 24 to 60 months.
description: MCL treatment class is part of the primary study objective relating to treatment patterns and will be descriptive only and use aggregated patient data.
measure: The rate of patients who change novel agent therapy dose (in months)
time frame: 24 to 60 months.
description: Summarizing MCL novel agent treatment dose changes are part of the primary study objective relating to treatment patterns and will be descriptive only. Time-to-dose change will be assessed. The rate of dose modification (in months) will be estimated using aggregated patient data. Summary statistics (mean, SD, median, IQR, minimum, and maximum) will be used to describe time on a particular dose, which will be measured from the start of treatment until the date of dose change or death.
measure: The rate of patients who interrupt novel agent therapy (in months)
time frame: 24 to 60 months
description: Summarizing MCL treatment interruptions are part of the primary study objective relating to treatment patterns and will be descriptive only. The rate of treatment interruption (in months) will be estimated using aggregated patient data. Summary statistics (mean, SD, median, IQR, minimum, and maximum) will be used to describe time on therapy, which will be measured from the start of treatment until the date of interruption or death.
measure: The rate of patients who discontinue novel agent therapy (in months)
time frame: 24 to 60 months
description: Summarizing MCL treatment discontinuations are part of the primary study objective relating to treatment patterns and will be descriptive only. The rate of treatment discontinuation (in months) will be estimated using aggregated patient data. Reasons for discontinuations will be collected and summarized categorically. Summary statistics (mean, SD, median, IQR, minimum, and maximum) will be used to describe time on therapy, which will be measured from the start of treatment until the date of discontinuation or death.
measure: The duration of MCL treatment
time frame: 24 to 60 months
description: Summarizing MCL treatment duration is part of the primary study objective relating to treatment patterns and will be descriptive only. The duration and number of cycles of each targeted treatment (mean, SD, median, IQR, minimum, and maximum) will be summarized. Summary statistics (mean, SD, median, IQR, minimum, and maximum) will be used to describe time on therapy (in months), which will be measured from the start of treatment until the date of discontinuation, interruption, switch or death.
measure: Estimate the overall response rate (ORR) among patients diagnosed with MCL and initiating treatment with novel therapies
time frame: 24 to 60 months.
description: ORR will be measured as the frequency and proportion of patients with a complete or partial response based on physician assessment during the observation period.
measure: Estimate the complete response rate (CR) among patients diagnosed with MCL and initiating treatment with novel therapies.
time frame: 24 to 60 months.
description: The CR will be calculated as the frequency and proportion of patients with a complete response based on physician assessment during the observation period.
measure: Estimate progression-free survival (PFS) among patients diagnosed with MCL and initiating treatment with novel therapies.
time frame: 24 to 60 months
description: All survival outcome measures will be descriptive only. PFS will be calculated as the time from the start of novel MCL treatment until progression or death. Summary statistics (mean, median, SD, IQR, minimum and maximum) will be used to describe PFS. Kaplan-Meier curves will be used to graphically show PFS.
measure: Estimate event-free survival (EFS) among patients diagnosed with MCL and initiating treatment with novel therapies.
time frame: 24 to 60 months
description: All survival outcome measures will be descriptive only. EFS will be calculated as the time from the start of novel MCL treatment to disease progression, death, or discontinuation of treatment for any reason (eg, toxicity, patient preference, or initiation of a new treatment without documented progression).
measure: Estimate overall survival (OS) among patients diagnosed with MCL and initiating treatment with novel therapies.
time frame: 24 to 60 months
description: All survival outcome measures will be descriptive only. OS will be captured using summary statistics (mean, SD, median, IQR, minimum and maximum), which will be used to describe time from diagnosis to death, time from enrollment to death, time from index novel MCL treatment to death and time from second treatment (if applicable) to death. Kaplan-Meier curves will be used to graphically show patient survival.
measure: The frequency of adverse events (AEs) in patients with MCL, where the term AE is used to include both serious and non-serious AEs.
time frame: 24 to 60 months
description: The frequency of patients with AEs will be tabulated from the start of index novel MCL treatment. AEs (both in terms of the MedDRA Preferred Terms (PTs) and Common Terminology Criteria for Adverse Events [CTCAE] grade) will be listed individually by patient and described by System Organ Class (SOC) and PT.
measure: The proportion of adverse events (AEs) in patients with MCL, where the term AE is used to include both serious and non-serious AEs.
time frame: 24 to 60 months
description: The proportion of patients with AEs will be calculated from the start of index novel MCL treatment. AEs (both in terms of the MedDRA Preferred Terms (PTs) and Common Terminology Criteria for Adverse Events [CTCAE] grade) will be listed individually by patient and described by System Organ Class (SOC) and PT.
measure: Estimate the frequency of serious adverse events (SAEs) in patients with MCL
time frame: 24 to 60 months
description: The proportion and frequency patients with SAEs will be tabulated from the start of index novel MCL treatment.
measure: Estimate the frequency of reported serious adverse safety events and adverse events leading to treatment changes associated with novel agents in patients with MCL
time frame: 24 to 60 months
description: The proportion and frequency of all SAEs and any AEs leading to treatment changes will be tabulated overall, and will also include the frequency and proportion of: (1) drug discontinuations, (2) dose interruptions or (3) dose changes.
measure: Estimate the frequency and proportion of patients experiencing a clinical event of interest (related to MCL or MCL treatment)
time frame: 24 to 60 months
description: The clinical events of interest that have an economic impact will be tabulated with the frequency and proportion of patients experiencing the event. Medical interventions used for managing clinical events of interest including but not limited to: diagnostic tests, procedures and medications.
measure: Estimate the frequency and proportion of patients experiencing healthcare resource utilization (HCRU), such as inpatient or emergency department visits
time frame: 24 to 60 months
description: Each type of physician visit will be tabulated at the aggregate level using the mean, SD, median, IQR, minimum and maximum. The total number of visits across all facilities will also be calculated.
measure: Tabulate HRQoL responses for the validated EORTC QLC-C30 Patient Reported Outcome (PRO) in patients with MCL
time frame: 24 to 60 months
description: Descriptive statistics for each validated PRO will include continuous measures (mean, median, SD, IQR, minimum, and maximum) or achievement of a particular threshold (frequency and proportion), if applicable. This study will collect patient perceptions of HRQoL based on PRO measures in patients with MCL by collecting the European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) on a quarterly basis. The EORTC QLQ-C30 has a recall/observation period during the past week. The questionnaire uses a 4-point Likert scale ranging from 1: "Not at all" to 4: "Very much," and scores by dimension range from 0 to 100.
measure: Tabulate HRQoL responses for the three selected, validated PRO-CTCAE PRO measures in patients with MCL
time frame: 24 to 60 months
description: Descriptive statistics for each validated PRO will include continuous measures (mean, median, SD, IQR, minimum, and maximum) or achievement of a particular threshold (frequency and proportion), if applicable. This study will collect patient perceptions of HRQoL by collecting the PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) (3 questions regarding muscle pain, joint pain, heart palpitations) on a quarterly basis. The PRO-CTCAE is intended for individuals 18 years or older and has a recall of the past 7 days. Responses to each question are scored from 0 to 4 (in order of increasing frequency and severity).
measure: Tabulate HRQoL responses for the validated PRO EuroQoL 5-Dimension 5-Level (EQ-5D-5L) in patients with MCL
time frame: 24 to 60 months
description: Descriptive statistics for each validated PRO will include continuous measures (mean, median, SD, IQR, minimum, and maximum) or achievement of a particular threshold (frequency and proportion), if applicable. This study will collect patient perceptions of HRQoL based on PRO measures in patients with MCL by collecting the EQ-5D-5L on a quarterly basis. This questionnaire is comprised of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and 1 visual analog scale used to assess a patient's self-rated health. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A unique health state is defined by combining 1 level from each of the 5 dimensions. Each health state is referred to in terms of a 5-digit code.
arm group label: Single cohort (registry) of MCL patients
description: Patients diagnosed with MCL who have initiated a novel therapy meeting inclusion/exclusion criteria in the past 6 months and treatment is ongoing at the time of enrollment.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: No
last name: Richard Hermann
role: Study Director
affiliation: Senior Medical Director, Haematology
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country: United States
citation: Ahn IE, Farooqui MZH, Tian X, Valdez J, Sun C, Soto S, Lotter J, Housel S, Stetler-Stevenson M, Yuan CM, Maric I, Calvo KR, Nierman P, Hughes TE, Saba NS, Marti GE, Pittaluga S, Herman SEM, Niemann CU, Pedersen LB, Geisler CH, Childs R, Aue G, Wiestner A. Depth and durability of response to ibrutinib in CLL: 5-year follow-up of a phase 2 study. Blood. 2018 May 24;131(21):2357-2366. doi: 10.1182/blood-2017-12-820910. Epub 2018 Feb 26.
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citation: AstraZeneca Pharmaceuticals LP. CALQUENCE® (acalabrutinib) prescribing information. October 2017.
citation: Chen Y, Wang M, Romaguera J. Current regimens and novel agents for mantle cell lymphoma. Br J Haematol. 2014 Oct;167(1):3-18. doi: 10.1111/bjh.13000. Epub 2014 Jun 28.
PMID: 24974852
citation: Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, Lister TA, Vose J, Grillo-Lopez A, Hagenbeek A, Cabanillas F, Klippensten D, Hiddemann W, Castellino R, Harris NL, Armitage JO, Carter W, Hoppe R, Canellos GP. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999 Apr;17(4):1244. doi: 10.1200/JCO.1999.17.4.1244. Erratum In: J Clin Oncol 2000 Jun;18(11):2351.
PMID: 10561185
citation: Cheson BD, Pfistner B, Juweid ME, Gascoyne RD, Specht L, Horning SJ, Coiffier B, Fisher RI, Hagenbeek A, Zucca E, Rosen ST, Stroobants S, Lister TA, Hoppe RT, Dreyling M, Tobinai K, Vose JM, Connors JM, Federico M, Diehl V; International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol. 2007 Feb 10;25(5):579-86. doi: 10.1200/JCO.2006.09.2403. Epub 2007 Jan 22.
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citation: Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.
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responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Mantle-Cell
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