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/NCT06025682</url>
    </required_header>
    <id_info>
      <org_study_id>INF0123</org_study_id>
      <nct_id>NCT06025682</nct_id>
    </id_info>
    <brief_title>Retrospective Observational Study on Infective Complications and Outcome of Patients With ALL Treated With INO</brief_title>
    <acronym>INO-FIRST</acronym>
    <official_title>Multicenter Retrospective Observational Study Analyzing Infective Complications and the Clinical Outcome of Patients With Acute Lymphoblastic Leukemia Treated With Inotuzumab Ozogamicin (INO-FIRST)</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>
      <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 goal of this observational study is to learn about infectious complications in patients&#xD;
        affected by B-cell acute lymphoblastic leukemia treated with inotuzumab-ozogamicin (INO). The&#xD;
        main question it aims to answer is:&#xD;
  &#xD;
        • incidence of infectious complications (bacterial, fungal, viral) in patients receiving&#xD;
        inotuzumab ozogamicin up to 60 days after the end of treatment&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The present study is a multicenter, retrospective, observational clinical-epidemiological&#xD;
        study on infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab&#xD;
        ozogamicin (INO). The study collects data from about 20 Hematologic Centers of the GIMEMA&#xD;
        Group treating B-cell acute lymphoblastic leukemia (ALL) patients with inotuzuumab-ozogamicin&#xD;
        (INO) over the last 5 years (2018-2023), according to the authorized indications and not&#xD;
        included in interventional clinical trials (randomized or not randomized).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of clinically or microbiologically documented infectious complications in patients receiving inotuzumab ozogamicin (INO) up to 60 days after the end of treatment (last dose administered)</measure>
      <time_frame>5 months</time_frame>
      <description>To estimate the rate of clinically or microbiologically documented infectious complications (bacterial, fungal, viral) in acute lymphoblastic leukemia patients receiving inotuzumab ozogamicin (INO) up to 60 days after the end of treatment (last dose administered).</description>
    </primary_outcome>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Acute Lymphoblastic Leukemia</condition>
    <condition>Infections</condition>
    <condition>Bacterial Infections</condition>
    <condition>Viral Infection</condition>
    <condition>Fungal Infection</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients with relapsed/refractory CD-22 positive acute lymphoblastic leukemia treated&#xD;
          with INO or with relapsed/refractory CD22 positive and Ph-positive B-ALL treated with INO&#xD;
          after failing at least one TKI inhibitor&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients (&gt;18 years old)&#xD;
  &#xD;
            -  Patients with relapsed/refractory CD-22 positive B-ALL treated with INO or with&#xD;
               relapsed/refractory CD22 positive and Ph-positive B-ALL treated with INO after failing&#xD;
               at least one TKI inhibitor&#xD;
  &#xD;
            -  Signed informed consent if applicable.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • Patients treated with INO in interventional clinical trials.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Livio Pagano</last_name>
      <role>Principal Investigator</role>
      <affiliation>Policlinico Universitario A. Gemelli, IRCCS-Università Cattolica del Sacro Cuore, Roma</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Paola Fazi</last_name>
      <phone>0670390528</phone>
      <email>p.fazi@gimema.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Enrico Crea</last_name>
      <phone>0670390514</phone>
      <email>e.crea@gimema.it</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 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>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
      <mesh_term>Bacterial Infections</mesh_term>
      <mesh_term>Mycoses</mesh_term>
      <mesh_term>Virus Diseases</mesh_term>
      <mesh_term>Leukemia</mesh_term>
      <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
      <mesh_term>Leukemia, Lymphoid</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06025682
  org study id: INF0123
  nct id: NCT06025682
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about infectious complications in patients
        affected by B-cell acute lymphoblastic leukemia treated with inotuzumab-ozogamicin (INO). The
        main question it aims to answer is:
  
        • incidence of infectious complications (bacterial, fungal, viral) in patients receiving
        inotuzumab ozogamicin up to 60 days after the end of treatment
  The present study is a multicenter, retrospective, observational clinical-epidemiological
        study on infectious complications (bacterial, fungal, viral) in patients receiving inotuzumab
        ozogamicin (INO). The study collects data from about 20 Hematologic Centers of the GIMEMA
        Group treating B-cell acute lymphoblastic leukemia (ALL) patients with inotuzuumab-ozogamicin
        (INO) over the last 5 years (2018-2023), according to the authorized indications and not
        included in interventional clinical trials (randomized or not randomized).
  observational model: Case-Only
  time perspective: Retrospective
  measure: Rate of clinically or microbiologically documented infectious complications in patients receiving inotuzumab ozogamicin (INO) up to 60 days after the end of treatment (last dose administered)
  time frame: 5 months
  description: To estimate the rate of clinically or microbiologically documented infectious complications (bacterial, fungal, viral) in acute lymphoblastic leukemia patients receiving inotuzumab ozogamicin (INO) up to 60 days after the end of treatment (last dose administered).
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  last name: Livio Pagano
  role: Principal Investigator
  affiliation: Policlinico Universitario A. Gemelli, IRCCS-Università Cattolica del Sacro Cuore, Roma
  last name: Paola Fazi
  phone: 0670390528
  email: p.fazi@gimema.it
  last name: Enrico Crea
  phone: 0670390514
  email: e.crea@gimema.it
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Bacterial Infections
  mesh term: Mycoses
  mesh term: Virus Diseases
  mesh term: Leukemia
  mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
  mesh term: Leukemia, Lymphoid
  sharing ipd: No