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/NCT06026644</url>
    </required_header>
    <id_info>
      <org_study_id>GIMEMA _QoL _CAR-T</org_study_id>
      <nct_id>NCT06026644</nct_id>
    </id_info>
    <brief_title>Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life</brief_title>
    <acronym>LNH012</acronym>
    <official_title>Health-Related Quality of Life Outcomes in Patients With Aggressive B-Cell Lymphomas Treated With CAR-T Cell Therapy in Real Life: A Multicenter Prospective Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gruppo Italiano Malattie EMatologiche dell'Adulto</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Gruppo Italiano Malattie EMatologiche dell'Adulto</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will ultimately aim at providing the scientific community with patient-reported&#xD;
        health status data that will contribute facilitate decision-makings. Short- and long-term&#xD;
        HRQoL and symptoms will be evaluated in a longitudinal fashion over time to improve the&#xD;
        understanding of the impact of the disease and CAR-T cell therapy on patients-wellbeing,&#xD;
        symptom burden and daily functioning. This study will capture useful information on the&#xD;
        impact of treatment toxicity, the burden of procedures on HRQoL outcomes. The planned&#xD;
        collection of PRO and physician-reported adverse events ad early time point will help to&#xD;
        compare and integrate these two points of view in healthcare assessment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Quality of life assessment&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 29, 2022</start_date>
    <completion_date type="Anticipated">April 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>24 Months</target_duration>
    <primary_outcome>
      <measure>The proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire</measure>
      <time_frame>at 12 months</time_frame>
      <description>To assess the proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The proportion of patients with a clinically meaningful improvement in the scales of the EORTC QLQ-C30 questionnaire</measure>
      <time_frame>at 12 months</time_frame>
      <description>To assess the proportion of patients with a clinically meaningful improvement in the scales of the EORTC QLQ-C30 questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The time to improvement in the PROMIS-Fatigue score</measure>
      <time_frame>After 2 years from date of registration</time_frame>
      <description>To assess the time to improvement in the PROMIS-Fatigue score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The time to improvement in the EORTC QLQ-C30 questionnaires</measure>
      <time_frame>After 2 years from date of registration</time_frame>
      <description>To assess the time to improvement in the EORTC QLQ-C30 questionnaires</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The time to improvement in the QLQ-NHL-HG29 questionnaires</measure>
      <time_frame>After 2 years from date of registration</time_frame>
      <description>To assess the time to improvement in the QLQ-NHL-HG29 questionnaires</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The trajectories over time (up to 24 months) of the mean scores from the PROMIS-Fatigue questionnaire.</measure>
      <time_frame>After 2 years from date of registration</time_frame>
      <description>To estimate the trajectories over time (up to 24 months) of the mean scores from the PROMIS-Fatigue questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-C30 questionnaire.</measure>
      <time_frame>After 2 years from date of registration</time_frame>
      <description>To estimate the trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-C30 questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-NHL-HG29 questionnaire.</measure>
      <time_frame>After 2 years from date of registration</time_frame>
      <description>To estimate the trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-NHL-HG29 questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Short-term (ie., day+10) patient-reported symptomatic toxicities by a core set of items from the PRO-CTCAE Item Library, and comparing them with those reported by the treating physicians.</measure>
      <time_frame>After + 10 day for infusion</time_frame>
      <description>To assess short-term (ie., day+10) patient-reported symptomatic toxicities by a core set of items from the PRO-CTCAE Item Library, and comparing them with those reported by the treating physicians</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The impact of CAR-T cell therapy on cognitive impairment as measured by the PROMIS Cognitive Function short form 8a questionnaire.</measure>
      <time_frame>After 2 years from date of registration</time_frame>
      <description>To investigate the impact of CAR-T cell therapy on cognitive impairment as measured by the PROMIS Cognitive Function short form 8a questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the PROMIS-Fatigue questionnaire.</measure>
      <time_frame>After 12 and 24 months from date of registration</time_frame>
      <description>To compare the long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the PROMIS-Fatigue questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the EORTC QLQ-C30 questionnaire.</measure>
      <time_frame>After 12 and 24 months from date of registration</time_frame>
      <description>To compare the long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the EORTC QLQ-C30 questionnaire.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Factors predicting response to therapy and survival outcomes</measure>
      <time_frame>After 2 years from date of registration</time_frame>
      <description>To identify pretreatment factors predicting response to therapy and survival outcomes.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>DLBCL - Diffuse Large B Cell Lymphoma</condition>
    <arm_group>
      <arm_group_label>Quality of life assessment</arm_group_label>
      <description>Quality of life questionnaires</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with Aggressive B-Cell Lymphomas Treated with CAR-T Cell Therapy&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary&#xD;
               mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL transformed&#xD;
               by indolent lymphoma and mantle cell lymphoma.&#xD;
  &#xD;
            -  Scheduled to received CAR-T cell product.&#xD;
  &#xD;
            -  Having a baseline PRO assessment.&#xD;
  &#xD;
            -  Adult patients (≥ 18 years old).&#xD;
  &#xD;
            -  Written informed consent provided.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having any documented or psychiatric or neurological disorder which may interfere with&#xD;
               self-reported HRQoL assessment.&#xD;
  &#xD;
            -  Not able to read and understand local language.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alice Di Rocco</last_name>
      <role>Principal Investigator</role>
      <affiliation>Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fabio Efficace</last_name>
      <phone>+3906441639831</phone>
      <email>f.efficace@gimema.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>francesca tartaglia</last_name>
      <phone>+3906441639838</phone>
      <email>f.tartaglia@gimema.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Aou Di Bologna - Policlinico S. Orsola-malpighi - Uoc Ematologia</name>
        <address>
          <city>Bologna</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Pier Luigi Zinzani</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Asst Degli Spedali Civili Di Brescia - Ssvd Centro Trapianti Midollo Per Adulti - Cattedra Di Ematologia</name>
        <address>
          <city>Brescia</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Domenico Russo</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>AOU Careggi - SOD terapie cellulari e Medicina Trasfusionale</name>
        <address>
          <city>Firenze</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Riccardo Saccardi</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti</name>
        <address>
          <city>Genova</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Massimiliano Gambella</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Fondazione Irccs &quot;Istituto Nazionale Tumori&quot; - Milano - Sc Ematologia</name>
        <address>
          <city>Milano</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Paolo Corradini</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Ad Indirizzo Oncologico</name>
        <address>
          <city>Palermo</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica</name>
        <address>
          <city>Pescara</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Elsa Pennese</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Aou Pisana - Uo Ematologia Universitaria</name>
        <address>
          <city>Pisa</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Enrico Orciuolo</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia</name>
        <address>
          <city>Roma</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alice Di Rocco</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ististuto Clinico Humanitas - Rozzano - Uo Oncologia Medica Ed Ematologia</name>
        <address>
          <city>Rozzano</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Stefania Bramanti</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino</name>
        <address>
          <city>Torino</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Federica Cavallo</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2</name>
        <address>
          <city>Torino</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Barbara Botto</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia</name>
        <address>
          <city>Vicenza</city>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maria Chiara Tisi</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma</mesh_term>
      <mesh_term>Lymphoma, B-Cell</mesh_term>
      <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    </condition_browse>
    <!-- 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/NCT06026644
  org study id: GIMEMA _QoL _CAR-T
  nct id: NCT06026644
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study will ultimately aim at providing the scientific community with patient-reported
        health status data that will contribute facilitate decision-makings. Short- and long-term
        HRQoL and symptoms will be evaluated in a longitudinal fashion over time to improve the
        understanding of the impact of the disease and CAR-T cell therapy on patients-wellbeing,
        symptom burden and daily functioning. This study will capture useful information on the
        impact of treatment toxicity, the burden of procedures on HRQoL outcomes. The planned
        collection of PRO and physician-reported adverse events ad early time point will help to
        compare and integrate these two points of view in healthcare assessment.
  Quality of life assessment
  observational model: Cohort
  time perspective: Prospective
  measure: The proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire
  time frame: at 12 months
  description: To assess the proportion of patients with a clinically meaningful improvement in the fatigue score of the PROMIS- Fatigue questionnaire
  measure: The proportion of patients with a clinically meaningful improvement in the scales of the EORTC QLQ-C30 questionnaire
  time frame: at 12 months
  description: To assess the proportion of patients with a clinically meaningful improvement in the scales of the EORTC QLQ-C30 questionnaire
  measure: The time to improvement in the PROMIS-Fatigue score
  time frame: After 2 years from date of registration
  description: To assess the time to improvement in the PROMIS-Fatigue score
  measure: The time to improvement in the EORTC QLQ-C30 questionnaires
  time frame: After 2 years from date of registration
  description: To assess the time to improvement in the EORTC QLQ-C30 questionnaires
  measure: The time to improvement in the QLQ-NHL-HG29 questionnaires
  time frame: After 2 years from date of registration
  description: To assess the time to improvement in the QLQ-NHL-HG29 questionnaires
  measure: The trajectories over time (up to 24 months) of the mean scores from the PROMIS-Fatigue questionnaire.
  time frame: After 2 years from date of registration
  description: To estimate the trajectories over time (up to 24 months) of the mean scores from the PROMIS-Fatigue questionnaire.
  measure: The trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-C30 questionnaire.
  time frame: After 2 years from date of registration
  description: To estimate the trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-C30 questionnaire.
  measure: The trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-NHL-HG29 questionnaire.
  time frame: After 2 years from date of registration
  description: To estimate the trajectories over time (up to 24 months) of the mean scores from the EORTC QLQ-NHL-HG29 questionnaire.
  measure: Short-term (ie., day+10) patient-reported symptomatic toxicities by a core set of items from the PRO-CTCAE Item Library, and comparing them with those reported by the treating physicians.
  time frame: After + 10 day for infusion
  description: To assess short-term (ie., day+10) patient-reported symptomatic toxicities by a core set of items from the PRO-CTCAE Item Library, and comparing them with those reported by the treating physicians
  measure: The impact of CAR-T cell therapy on cognitive impairment as measured by the PROMIS Cognitive Function short form 8a questionnaire.
  time frame: After 2 years from date of registration
  description: To investigate the impact of CAR-T cell therapy on cognitive impairment as measured by the PROMIS Cognitive Function short form 8a questionnaire.
  measure: The long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the PROMIS-Fatigue questionnaire.
  time frame: After 12 and 24 months from date of registration
  description: To compare the long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the PROMIS-Fatigue questionnaire.
  measure: The long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the EORTC QLQ-C30 questionnaire.
  time frame: After 12 and 24 months from date of registration
  description: To compare the long-term HRQoL and fatigue profile of patients with that of their peers from the general population, using the EORTC QLQ-C30 questionnaire.
  measure: Factors predicting response to therapy and survival outcomes
  time frame: After 2 years from date of registration
  description: To identify pretreatment factors predicting response to therapy and survival outcomes.
  arm group label: Quality of life assessment
  description: Quality of life questionnaires
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Alice Di Rocco
  role: Principal Investigator
  affiliation: Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia
  last name: Fabio Efficace
  phone: +3906441639831
  email: f.efficace@gimema.it
  last name: francesca tartaglia
  phone: +3906441639838
  email: f.tartaglia@gimema.it
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Active, not recruiting
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Lymphoma
  mesh term: Lymphoma, B-Cell
  mesh term: Lymphoma, Large B-Cell, Diffuse