xml: <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/NCT05999877</url>
    </required_header>
    <id_info>
      <org_study_id>D8221R00003</org_study_id>
      <nct_id>NCT05999877</nct_id>
    </id_info>
    <brief_title>PICAROS - Acalabrutinib RWE on 1L CLL in Spain</brief_title>
    <acronym>PICAROS</acronym>
    <official_title>Non-interventional Cohort Study of Patients Previously Untreated or First-generation BTKi Intolerant With Chronic Lymphocytic Leukemia Describing the First-line Use of Acalabrutinib and Its Real-world Outcomes in Spain: the PICAROS Study</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>
        This is a multicenter non-interventional study (NIS) on patients with CLL who have been&#xD;
        treated with acalabrutinib for the first time within the year before the first site&#xD;
        initiation visit in Spain.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multicenter, non-interventional study (NIS) based on ambispective (including&#xD;
        retrospective and/or prospective) real-world data collection of patients with CLL who have&#xD;
        been treated with acalabrutinib for the first time within the year before the first site&#xD;
        initiation visit, from approximately 50 Hospitals in Spain. Patients who had already&#xD;
        initiated acalabrutinib therapy will be identified by the investigators and offered to&#xD;
        participate in the study.&#xD;
  &#xD;
        The start of acalabrutinib treatment (index date) must be prior to the first site initiation&#xD;
        visit. Therefore, the clinical decision of starting patient on acalabrutinib has&#xD;
        independently occurred prior to the patient inclusion into this study. Patients' eligibility&#xD;
        for study inclusion is regardless of their current status of acalabrutinib therapy, for&#xD;
        example, patients already deceased or discontinued therapy are still eligible to be included&#xD;
        into this study. Patient data will be collected both retrospectively and/or prospectively up&#xD;
        to 3.5 years from the first site initiation visit. For patients who received acalabrutinib&#xD;
        therapy and have deceased, only retrospective medical chart review will be conducted.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 11, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</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>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of patients on acalabrutinib therapy at 24 months after treatment initiation.</measure>
      <time_frame>24 months after treatment initiation.</time_frame>
      <description>Proportion of patients on acalabrutinib therapy at 24 months after treatment initiation.&#xD;
  In addition to this outcome measured in the overall population, it will also be assessed by the following factors:&#xD;
  the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression),&#xD;
  presence/absence of risk factors (i.e., del17p, TP53 mutation, and unmutated IGHV).&#xD;
  cardiovascular comorbidities (yes/no).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Start dose in mg.</measure>
      <time_frame>At acalabrutinib start date</time_frame>
      <description>Acalabrutinib dose at starting treatment, overall and by the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patients with acalabrutinib dose reductions (n, %), temporary interruptions (n, %), and permanent discontinuations (n, %).</measure>
      <time_frame>From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.</time_frame>
      <description>Acalabrutinib dose reductions, temporary interruptions, and permanent discontinuations, overall and by the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment duration in months.</measure>
      <time_frame>From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.</time_frame>
      <description>Treatment duration, overall and by the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).&#xD;
  Baseline patient characteristics associated with treatment duration in multivariate analyses, overall and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment adherence according to the percentage of days covered (PDC) while receiving acalabrutinib.</measure>
      <time_frame>From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.</time_frame>
      <description>Treatment adherence according to the percentage of days covered (PDC) while receiving acalabrutinib, overall and by the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).&#xD;
  The PDC will be based on data available on acalabrutinib treatment in pharmacy records, and defined as the percentage of days a patient has the medication available in a given period of time:&#xD;
  PDC (%)=(No.days covered)/(No.days of interest)×100</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TTNT (i.e., the time from the date of first dose of acalabrutinib to the first dose of the next treatment for CLL, or death from any cause [i.e. deaths are not censored]).</measure>
      <time_frame>From the date of first dose of acalabrutinib to the first dose of the next treatment for CLL or death from any cause, whichever came first, assessed up to 3.5 years of prospective study follow-up.</time_frame>
      <description>TTNT (i.e., the time from the date of first dose of acalabrutinib to the first dose of the next treatment for CLL, or death from any cause [i.e. deaths are not censored]), overall and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>OS (i.e., the time from the date of first dose of acalabrutinib to death from any cause).</measure>
      <time_frame>From the date of first dose of acalabrutinib to death from any cause, whichever came first, assessed up to 3.5 years of prospective study follow-up.</time_frame>
      <description>OS (i.e., the time from the date of first dose of acalabrutinib to death from any cause), overall and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events that lead to acalabrutinib dose changes, temporary interruptions, or permanent discontinuation. Adverse events that are considered serious during acalabrutinib treatment. Events of clinical interest.</measure>
      <time_frame>From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.</time_frame>
      <description>Adverse events that lead to acalabrutinib dose changes, temporary interruptions, or permanent discontinuation.&#xD;
  Adverse events that are considered serious (including fatal events) during acalabrutinib treatment, globally and treatment related (when available).&#xD;
  Events of clinical interest (atrial fibrillation, hypertension, bleeding, infections, ventricular arrhythmias, hepatotoxicity, secondary primary malignancies, cytopenia, and pneumonitis) during acalabrutinib treatment, globally and treatment related (when available).They will be described overall and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Best ORR (i.e., the proportion of patients that achieved complete or partial response) during acalabrutinib treatment.</measure>
      <time_frame>From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.</time_frame>
      <description>Best ORR (i.e., the proportion of patients that achieved complete or partial response) during acalabrutinib treatment, overall and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).</description>
    </other_outcome>
    <other_outcome>
      <measure>rwPFS (i.e., the time from the date of first dose of acalabrutinib to disease progression, or death from any cause).</measure>
      <time_frame>From the date of first dose of acalabrutinib to disease progression or death from any cause, whichever came first, assessed up to 3.5 years of prospective study follow-up.</time_frame>
      <description>rwPFS (i.e., the time from the date of first dose of acalabrutinib to disease progression, or death from any cause), overall and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).</description>
    </other_outcome>
    <other_outcome>
      <measure>Scores on the EORTC QLQ-C30, its specific module for CLL QLQ-CLL17, and SATMED-Q during acalabrutinib treatment.</measure>
      <time_frame>Study inclusion, month 3, month 6 and subsequent every 6 months during acalabrutinib treatment up to 3.5 years of prospective study follow-up.</time_frame>
      <description>Scores on the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) and its specific module for CLL QLQ-CLL17 reported at inclusion, month 3, month 6 and subsequent every 6-month follow-up during acalabrutinib treatment.&#xD;
  Satisfaction with acalabrutinib treatment reported at study inclusion, month 3, month 6 and subsequent every 6-month follow-up during acalabrutinib treatment (Treatment Satisfaction Questionnaire; SATMED-Q).&#xD;
  These outcomes will be evaluated overall and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).</description>
    </other_outcome>
    <other_outcome>
      <measure>Frequency of patients switching from capsules to tablets (if available).</measure>
      <time_frame>From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.</time_frame>
      <description>Frequency of patients switching from capsules to tablets (if available).</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient satisfaction after switching from capsules to tablets (if available).</measure>
      <time_frame>From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.</time_frame>
      <description>Patient satisfaction according to SATMED-Q scores after switching from capsules to tablets (if available).</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient adherence after switching from capsules to tablets (if available).</measure>
      <time_frame>From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.</time_frame>
      <description>Patient adherence according to PDC after switching from capsules to tablets (if available).</description>
    </other_outcome>
    <enrollment type="Anticipated">315</enrollment>
    <condition>Chronic Lymphocytic Leukemia</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The study aims to include approximately 315 patients who started acalabrutinib for the&#xD;
          first time for the treatment of their CLL. They may include patients receiving&#xD;
          acalabrutinib either as first treatment for their previously untreated CLL or patients who&#xD;
          switched from first generation BTK inhibitor, used in first-line, to acalabrutinib due to&#xD;
          intolerance.&#xD;
  &#xD;
          To minimize selection biases, all patients (alive or deceased) identified on acalabrutinib&#xD;
          will be eligible for inclusion into the study.&#xD;
  &#xD;
          These patients will be included from approximately 50 hospitals distributed throughout&#xD;
          Spain. The identification of patients for inclusion will be consecutive backwards until&#xD;
          reaching a maximum of 15 patients per site.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18 years old at starting acalabrutinib treatment.&#xD;
  &#xD;
            -  Diagnosis of CLL.&#xD;
  &#xD;
            -  Start of acalabrutinib treatment (index date) in treatment-naïve CLL patients or those&#xD;
               switching in first-line between first-generation BTK inhibitor to acalabrutinib due to&#xD;
               intolerance in absence of progression according to routine clinical practice within&#xD;
               the year before the first site initiation visit. Decision to administer acalabrutinib&#xD;
               must be made and documented prior to inclusion into the study and must follow local&#xD;
               clinical practice.&#xD;
  &#xD;
            -  Informed consent (for alive patients).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Enrolled in any clinical trial during acalabrutinib treatment.&#xD;
  &#xD;
            -  Patients who are unable to understand the study and its questionnaires due to&#xD;
               insufficient knowledge of the Spanish language or their health status.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>AstraZeneca Clinical Study Information Center</last_name>
      <phone>1-877-240-9479</phone>
      <email>information.center@astrazeneca.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Almeria</city>
          <state>Andalucia</state>
          <zip>4009</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Cordoba</city>
          <state>Andalucia</state>
          <zip>14004</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Granada</city>
          <state>Andalucia</state>
          <zip>18014</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Malaga</city>
          <state>Andalucia</state>
          <zip>29010</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Sevilla</city>
          <state>Andalucia</state>
          <zip>41013</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Zaragoza</city>
          <state>Aragon</state>
          <zip>50009</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Oviedo</city>
          <state>Asturias</state>
          <zip>33011</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Santander</city>
          <state>Cantabria</state>
          <zip>39008</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Salamanca</city>
          <state>Castilla Y Leon</state>
          <zip>37007</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Segovia</city>
          <state>Castilla Y Leon</state>
          <zip>40002</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Valladolid</city>
          <state>Castilla Y Leon</state>
          <zip>47003</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Barcelona</city>
          <state>Cataluna</state>
          <zip>8003</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Barcelona</city>
          <state>Cataluna</state>
          <zip>8025</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Barcelona</city>
          <state>Cataluna</state>
          <zip>8035</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Barcelona</city>
          <state>Cataluna</state>
          <zip>8036</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Granollers</city>
          <state>Cataluna</state>
          <zip>8402</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Hospitalet de Llobregat</city>
          <state>Cataluna</state>
          <zip>8908</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Lleida</city>
          <state>Cataluna</state>
          <zip>25198</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Terrassa</city>
          <state>Cataluna</state>
          <zip>8221</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Madrid</city>
          <state>Comunidad De Madrid</state>
          <zip>28006</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Madrid</city>
          <state>Comunidad De Madrid</state>
          <zip>28031</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Madrid</city>
          <state>Comunidad De Madrid</state>
          <zip>28034</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Madrid</city>
          <state>Comunidad De Madrid</state>
          <zip>28040</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Madrid</city>
          <state>Comunidad De Madrid</state>
          <zip>28041</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Madrid</city>
          <state>Comunidad De Madrid</state>
          <zip>28046</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Madrid</city>
          <state>Comunidad De Madrid</state>
          <zip>28905</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Majadahonda</city>
          <state>Comunidad De Madrid</state>
          <zip>28222</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Alicante</city>
          <state>Comunidad Valenciana</state>
          <zip>3010</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Valencia</city>
          <state>Comunidad Valenciana</state>
          <zip>46010</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Valencia</city>
          <state>Comunidad Valenciana</state>
          <zip>46014</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Valencia</city>
          <state>Comunidad Valenciana</state>
          <zip>46026</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Ourense</city>
          <state>Galicia</state>
          <zip>32005</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Santiago de Compostela</city>
          <state>Galicia</state>
          <zip>15706</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Vigo</city>
          <state>Galicia</state>
          <zip>36312</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Las Palmas de Gran Canaria</city>
          <state>Islas Canarias</state>
          <zip>35019</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Donostia</city>
          <state>Pais Vasco</state>
          <zip>20014</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Galdakao</city>
          <state>Pais Vasco</state>
          <zip>48960</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>El Palmar</city>
          <state>Region De Murcia</state>
          <zip>30120</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Murcia</city>
          <state>Region De Murcia</state>
          <zip>30008</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Observational</keyword>
    <keyword>Chronic lymphocytic leukemia</keyword>
    <keyword>Acalabrutinib</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>
    <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 Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.&#xD;
  &quot;Yes&quot;, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.</ipd_description>
      <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer 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 anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.</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>
  
  
text: 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/NCT05999877
  org study id: D8221R00003
  nct id: NCT05999877
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a multicenter non-interventional study (NIS) on patients with CLL who have been
        treated with acalabrutinib for the first time within the year before the first site
        initiation visit in Spain.
  This is a multicenter, non-interventional study (NIS) based on ambispective (including
        retrospective and/or prospective) real-world data collection of patients with CLL who have
        been treated with acalabrutinib for the first time within the year before the first site
        initiation visit, from approximately 50 Hospitals in Spain. Patients who had already
        initiated acalabrutinib therapy will be identified by the investigators and offered to
        participate in the study.
  
        The start of acalabrutinib treatment (index date) must be prior to the first site initiation
        visit. Therefore, the clinical decision of starting patient on acalabrutinib has
        independently occurred prior to the patient inclusion into this study. Patients' eligibility
        for study inclusion is regardless of their current status of acalabrutinib therapy, for
        example, patients already deceased or discontinued therapy are still eligible to be included
        into this study. Patient data will be collected both retrospectively and/or prospectively up
        to 3.5 years from the first site initiation visit. For patients who received acalabrutinib
        therapy and have deceased, only retrospective medical chart review will be conducted.
  observational model: Cohort
  time perspective: Other
  measure: Proportion of patients on acalabrutinib therapy at 24 months after treatment initiation.
  time frame: 24 months after treatment initiation.
  description: Proportion of patients on acalabrutinib therapy at 24 months after treatment initiation.
  In addition to this outcome measured in the overall population, it will also be assessed by the following factors:
  the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression),
  presence/absence of risk factors (i.e., del17p, TP53 mutation, and unmutated IGHV).
  cardiovascular comorbidities (yes/no).
  measure: Start dose in mg.
  time frame: At acalabrutinib start date
  description: Acalabrutinib dose at starting treatment, overall and by the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).
  measure: Patients with acalabrutinib dose reductions (n, %), temporary interruptions (n, %), and permanent discontinuations (n, %).
  time frame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
  description: Acalabrutinib dose reductions, temporary interruptions, and permanent discontinuations, overall and by the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).
  measure: Treatment duration in months.
  time frame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
  description: Treatment duration, overall and by the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).
  Baseline patient characteristics associated with treatment duration in multivariate analyses, overall and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).
  measure: Treatment adherence according to the percentage of days covered (PDC) while receiving acalabrutinib.
  time frame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
  description: Treatment adherence according to the percentage of days covered (PDC) while receiving acalabrutinib, overall and by the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).
  The PDC will be based on data available on acalabrutinib treatment in pharmacy records, and defined as the percentage of days a patient has the medication available in a given period of time:
  PDC (%)=(No.days covered)/(No.days of interest)×100
  measure: TTNT (i.e., the time from the date of first dose of acalabrutinib to the first dose of the next treatment for CLL, or death from any cause [i.e. deaths are not censored]).
  time frame: From the date of first dose of acalabrutinib to the first dose of the next treatment for CLL or death from any cause, whichever came first, assessed up to 3.5 years of prospective study follow-up.
  description: TTNT (i.e., the time from the date of first dose of acalabrutinib to the first dose of the next treatment for CLL, or death from any cause [i.e. deaths are not censored]), overall and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).
  measure: OS (i.e., the time from the date of first dose of acalabrutinib to death from any cause).
  time frame: From the date of first dose of acalabrutinib to death from any cause, whichever came first, assessed up to 3.5 years of prospective study follow-up.
  description: OS (i.e., the time from the date of first dose of acalabrutinib to death from any cause), overall and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).
  measure: Adverse events that lead to acalabrutinib dose changes, temporary interruptions, or permanent discontinuation. Adverse events that are considered serious during acalabrutinib treatment. Events of clinical interest.
  time frame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
  description: Adverse events that lead to acalabrutinib dose changes, temporary interruptions, or permanent discontinuation.
  Adverse events that are considered serious (including fatal events) during acalabrutinib treatment, globally and treatment related (when available).
  Events of clinical interest (atrial fibrillation, hypertension, bleeding, infections, ventricular arrhythmias, hepatotoxicity, secondary primary malignancies, cytopenia, and pneumonitis) during acalabrutinib treatment, globally and treatment related (when available).They will be described overall and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).
  measure: Best ORR (i.e., the proportion of patients that achieved complete or partial response) during acalabrutinib treatment.
  time frame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
  description: Best ORR (i.e., the proportion of patients that achieved complete or partial response) during acalabrutinib treatment, overall and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).
  measure: rwPFS (i.e., the time from the date of first dose of acalabrutinib to disease progression, or death from any cause).
  time frame: From the date of first dose of acalabrutinib to disease progression or death from any cause, whichever came first, assessed up to 3.5 years of prospective study follow-up.
  description: rwPFS (i.e., the time from the date of first dose of acalabrutinib to disease progression, or death from any cause), overall and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).
  measure: Scores on the EORTC QLQ-C30, its specific module for CLL QLQ-CLL17, and SATMED-Q during acalabrutinib treatment.
  time frame: Study inclusion, month 3, month 6 and subsequent every 6 months during acalabrutinib treatment up to 3.5 years of prospective study follow-up.
  description: Scores on the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) and its specific module for CLL QLQ-CLL17 reported at inclusion, month 3, month 6 and subsequent every 6-month follow-up during acalabrutinib treatment.
  Satisfaction with acalabrutinib treatment reported at study inclusion, month 3, month 6 and subsequent every 6-month follow-up during acalabrutinib treatment (Treatment Satisfaction Questionnaire; SATMED-Q).
  These outcomes will be evaluated overall and according to the reason for treatment initiation (i.e., first-line treatment-naïve patients, and those switching due to intolerance in absence of progression).
  measure: Frequency of patients switching from capsules to tablets (if available).
  time frame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
  description: Frequency of patients switching from capsules to tablets (if available).
  measure: Patient satisfaction after switching from capsules to tablets (if available).
  time frame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
  description: Patient satisfaction according to SATMED-Q scores after switching from capsules to tablets (if available).
  measure: Patient adherence after switching from capsules to tablets (if available).
  time frame: From acalabrutinib start to acalabrutinib end, assessed up to 3.5 years of prospective study follow-up.
  description: Patient adherence according to PDC after switching from capsules to tablets (if available).
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: AstraZeneca Clinical Study Information Center
  phone: 1-877-240-9479
  email: information.center@astrazeneca.com
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: Spain
  responsible party type: Sponsor
  mesh term: Leukemia
  mesh term: Leukemia, Lymphoid
  mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
  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 Vivli.org. All requests 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 approved.
  ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer 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 anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
  ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home