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/NCT06008691</url>
    </required_header>
    <id_info>
      <org_study_id>FIL_MAB</org_study_id>
      <nct_id>NCT06008691</nct_id>
    </id_info>
    <brief_title>A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice</brief_title>
    <acronym>FIL_MAB</acronym>
    <official_title>A Prospective, Observational Cohort Study to Evaluate the Clinical Impact of Novel Monoclonal Antibodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian Clinical Practice</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Italiana Linfomi - ETS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Roche Pharma AG</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Fondazione Italiana Linfomi - ETS</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 prospective, observational cohort study to evaluate the clinical impact of novel&#xD;
        Monoclonal AntiBodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian clinical&#xD;
        practice.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a large prospective, observational cohort study aimed at collecting clinical&#xD;
        information on use, feasibility, short- and long-term efficacy and short- and long-term&#xD;
        toxicity of novel MAB that have received approval from EMA since 2020 and are prescribed&#xD;
        according to the indications for use authorized for marketing in Italy.&#xD;
  &#xD;
        Patients entering the study will be subdivided into different cohorts based on approved&#xD;
        treatment indications, type of antibody employed and histological subtype. Additional&#xD;
        sub-cohorts will be defined if needed.&#xD;
  &#xD;
        Final outputs will be based according to:&#xD;
  &#xD;
          -  Per indication analysis;&#xD;
  &#xD;
          -  Pooled analyses by type of antibody and subtype and other parameters;&#xD;
  &#xD;
          -  A general analysis of the whole cohort.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2038</completion_date>
    <primary_completion_date type="Anticipated">October 2038</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>Overall response rate (ORR)</measure>
      <time_frame>At least 5 years</time_frame>
      <description>ORR will be defined according to Lugano 2014 criteria as the proportion of patients who have a partial response (PR) or complete response to therapy (CR+PR).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Complete Response rate (CRR)</measure>
      <time_frame>At least 5 years</time_frame>
      <description>CRR will be defined according to Lugano 2014 criteria and will include only patients who achieved a CR at the end of treatment program. The best overall response will be defined as the best response between the date of beginning of therapy and the last restaging. Patients without response assessment (due to whatever reason) will be considered as non-responders.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Progression free survival (PFS)</measure>
      <time_frame>At least 5 years</time_frame>
      <description>PFS is defined as the time between the date of enrollment and the first documentation of recurrence, progression or death from any cause; responding patients and patients who are lost to follow up will be censored at their last assessment date.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>At least 5 years</time_frame>
      <description>OS is defined as the time between the start of treatment until death from any cause; patients who are lost at follow up will be censored at their last assessment date.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Event free survival (EFS)</measure>
      <time_frame>At least 5 years</time_frame>
      <description>ESFS is defined as the time from start of treatment to disease progression, death, or discontinuation of treatment for any reason (e.g. toxicity, patient preference), or initiation of a new treatment without documented progression.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time-to-next treatment (TTNT)</measure>
      <time_frame>At least 5 years</time_frame>
      <description>TTNT represents the interval from commencement of one treatment to initiation of the next line of therapy.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>non-relapse mortality (NRM)</measure>
      <time_frame>At least 5 years</time_frame>
      <description>NRM is defined as death without recurrent or progressive disease after treatment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Duration of response (DOR)</measure>
      <time_frame>At least 5 years</time_frame>
      <description>DOR is defined as the time from the first documentation of tumor response (CR/PR) to disease progression or death according to Lugano 2014 criteria.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of Early/Late Adverse Events</measure>
      <time_frame>At least 5 years</time_frame>
      <description>Toxicities will be recorded and classified according to the definitions of the latest version of the NCI CTCAE. Toxicity events will be determined by the incidence of severe, life-threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (SAEs) commencing after the first induction dose or at any time during therapy. Early and toxic deaths and cause of any death. Special focus on second tumors, infections and autoimmune complications. Particularly:&#xD;
  Hematological and extra-hematological toxicities Grade &gt; 2&#xD;
  Infusional adverse events, will be recorded any Grade&#xD;
  Toxicities of specific interest on second tumors, infections and autoimmune complications will be recorded any Grade&#xD;
  Early and toxic deaths and cause of any death.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1500</enrollment>
    <condition>Non-Hodgkin Lymphoma, B-cell</condition>
    <arm_group>
      <arm_group_label>B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA and AIFA).</arm_group_label>
      <description>B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA since 2020 and prescribed according to the indications for use authorized for marketing in Italy).&#xD;
  Patients first-line and relapsed or refractory who had received at least 1 dose of MAB.&#xD;
  Different cohorts will be analyzed according to approved treatment indications, type of antibody employed and NHL hystotypes.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>&quot;novel&quot; MAB (alone or in combination)</intervention_name>
      <description>&quot;novel&quot; MAB (alone or in combination) based on presence of an EMA clinical indication since 2020 and prescribed according to the indications for use authorized for marketing in Italy</description>
      <arm_group_label>B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA and AIFA).</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with diagnosis of B-cell NHL both first-line and relapsed or refractory aimed to&#xD;
          be treated in indication with a &quot;novel&quot; MAB (alone or in combination) based on presence of&#xD;
          an EMA clinical indication since 2020 and prescribed according to the indications for use&#xD;
          authorized for marketing in Italy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with diagnosis of B-cell NHL and need of treatment (as per guideline&#xD;
               indications), both first-line and relapsed or refractory.&#xD;
  &#xD;
            -  Patients aimed to be treated in indication with a &quot;novel&quot; MAB (alone or in&#xD;
               combination) based on presence of an EMA clinical indication since 2020 and prescribed&#xD;
               according to the indications for use authorized for marketing in Italy.&#xD;
  &#xD;
            -  Signed written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Being involved in a prospective interventional trial outside indication.&#xD;
  &#xD;
            -  Patients treated outside approved indications:&#xD;
  &#xD;
                 -  648-approved indication.&#xD;
  &#xD;
                 -  5% AIFA support.&#xD;
  &#xD;
                 -  Compassionate use.&#xD;
  &#xD;
            -  Age less than 18 years.&#xD;
  &#xD;
            -  Inability to provide an informed consent.&#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_official>
      <last_name>Marco Ladetto, Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>AO SS Antonio e Biagio e Cesare Arrigo, Alessandria</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Uffici Studi FIL</last_name>
      <phone>+390131033153</phone>
      <email>startup@filinf.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Uffici Studi FIL</last_name>
      <phone>+390599769913</phone>
      <email>gestionestudi@filinf.it</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Istituto Oncologico del Mediterraneo SPA - Oncologico</name>
        <address>
          <city>Viagrande</city>
          <state>Catania</state>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Giulio Antonio Milone, MD</last_name>
        <email>giulio.milone89@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ospedale SS. Cosma e Damiano - Ospedale San Jacopo - SOS Oncoematologia ed ematologia clinica</name>
        <address>
          <city>Pescia</city>
          <state>Pistoia</state>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Roberta Giachetti, MD</last_name>
        <email>roberta.giachetti@uslcentro.toscana.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia</name>
        <address>
          <city>Alessandria</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Marco Ladetto, Prof.</last_name>
        <email>marco.ladetto@ospedale.al.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>AOU Ospedali Riuniti - Clinica di Ematologia</name>
        <address>
          <city>Ancona</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Guido Gini, MD</last_name>
        <email>guido.gini@ospedaliriuniti.marche.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico</name>
        <address>
          <city>Avellino</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Sonya De Lorenzo, MD</last_name>
        <email>sonya.delorenzo@tin.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati</name>
        <address>
          <city>Aviano</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Michele Spina, MD</last_name>
        <email>mspina@cro.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia</name>
        <address>
          <city>Bari</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Giacomo Loseto, MD</last_name>
        <email>loseto.giacomo@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ospedale &quot;Monsignor Raffaele Dimiccoli&quot; - Ematologia</name>
        <address>
          <city>Barletta</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Giuseppe Tarantini, MD</last_name>
        <email>giuseppetarantini0@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Azienda Ospedaliera Papa Giovanni XXIII - Ematologia</name>
        <address>
          <city>Bergamo</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Alessandro Rambaldi, MD</last_name>
        <email>arambaldi@asst-pg23.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nuovo Ospedale degli Infermi - SSD Ematologia</name>
        <address>
          <city>Biella</city>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Policlinico S. Orsola-Malpighi - Istituto di Ematologia &quot;Seragnoli&quot;</name>
        <address>
          <city>Bologna</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Beatrice Casadei, MD</last_name>
        <email>beatrice.casadei10@unibo.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>ASST Spedali Civili di Brescia - Ematologia</name>
        <address>
          <city>Brescia</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Alessandro Re, MD</last_name>
        <email>alessandro.re@asst-spedalicivili.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ospedale Businco - SC Ematologia e CTMO</name>
        <address>
          <city>Cagliari</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Maria Pina Simula, MD</last_name>
        <email>mariap.simula@aob.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Fondazione del Piemonte per l'Oncologia - IRCCS - Ematologia</name>
        <address>
          <city>Candiolo</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Pio Manlio Mirko Frascione, MD</last_name>
        <email>piomanliomirko.frascione@ircc.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Osp. civile di Carrara - Oncologia Medica</name>
        <address>
          <city>Carrara</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Roberta Della Seta, MD</last_name>
        <email>rdellaseta@alice.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ospedale di Castelfranco Veneto - Ematologia</name>
        <address>
          <city>Castelfranco Veneto</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Mariella Lo Schirico, MD</last_name>
        <email>mariella.loschirico@iov.veneto.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia</name>
        <address>
          <city>Catania</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Ugo Consoli, MD</last_name>
        <email>ugo.consoli144@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia</name>
        <address>
          <city>Catania</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Annalisa Chiarenza, MD</last_name>
        <email>annalisa.chiarenza@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ospedale di Civitanova Marche - UOSD EMATOLOGIA AREA VASTA 3 MACERATA</name>
        <address>
          <city>Civitanova Marche</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Caterina Bocci, MD</last_name>
        <email>cate.bocci@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo</name>
        <address>
          <city>Cuneo</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Alessia Castellino, MD</last_name>
        <email>castellino.ale@ospedale.cuneo.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia</name>
        <address>
          <city>Firenze</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Luca Nassi, MD</last_name>
        <email>nassil@aou-careggi.toscana.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ospedale Versilia USL NORDOVEST Toscana - UOS Ematologia</name>
        <address>
          <city>Lido Di Camaiore</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Federico Simonetti, MD</last_name>
        <email>federico.simonetti@uslnordovest.toscana.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ospedale di Livorno - Ematologia</name>
        <address>
          <city>Livorno</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Sofya Kovalchuk, MD</last_name>
        <email>sofya.kova82@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>AOU G. Martino - U.O.C. Ematologia</name>
        <address>
          <city>Messina</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Alessandro Allegra, MD</last_name>
        <email>alessandro.allegra@unime.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia</name>
        <address>
          <city>Milano</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Vittorio Ruggero Zilioli, MD</last_name>
        <email>vittorioruggero.zilioli@ospedaleniguarda.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia</name>
        <address>
          <city>Milano</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Paolo Corradini, Prof.</last_name>
        <email>paolo.corradini@unimi.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia</name>
        <address>
          <city>Milano</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Andrès Ferreri, MD</last_name>
        <email>andres.ferreri@hsr.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Fondazione IRCCS San Gerardo dei Tintori - Ematologia</name>
        <address>
          <city>Monza</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Federica Cocito, MD</last_name>
        <email>cocitofederica@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>AOU Federico II - Ematologia</name>
        <address>
          <city>Napoli</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Fabrizio Pane, Prof.</last_name>
        <email>fabrizio.pane@unina.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>AOU Maggiore della Carità di Novara - SCDU Ematologia</name>
        <address>
          <city>Novara</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Riccardo Bruna, MD</last_name>
        <email>riccardo.bruna@med.uniupo.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1</name>
        <address>
          <city>Padova</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Dario Marino, MD</last_name>
        <email>dario.marino@iov.veneto.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Presidio ospedaliero &quot;A. TORTORA&quot; - U.O. Onco-ematologia</name>
        <address>
          <city>Pagani</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Catello Califano, MD</last_name>
        <email>c.califano@aslsalerno.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia</name>
        <address>
          <city>Palermo</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Caterina Patti, MD</last_name>
        <email>k.patti@villasofia.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia</name>
        <address>
          <city>Pavia</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Luca Arcaini, Prof.</last_name>
        <email>luca.arcaini@unipv.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi</name>
        <address>
          <city>Pescara</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Elsa Pennese, MD</last_name>
        <email>elsa.pennese@asl.pe.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ospedale Guglielmo da Saliceto - U.O. Ematologia</name>
        <address>
          <city>Piacenza</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Annalisa Arcari, MD</last_name>
        <email>a.arcari@ausl.pc.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>A.O.R. &quot;San Carlo&quot; - U.O. Ematologia</name>
        <address>
          <city>Potenza</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Michele Cimminiello, MD</last_name>
        <email>miki-doc@virgilio.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ospedale delle Croci - Ematologia</name>
        <address>
          <city>Ravenna</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Monica Tani, MD</last_name>
        <email>monica.tani@auslromagna.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia</name>
        <address>
          <city>Reggio Calabria</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Caterina Stelitano, MD</last_name>
        <email>caterinastelitano27@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia</name>
        <address>
          <city>Reggio Emilia</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Stefano Luminari, Prof.</last_name>
        <email>stefano.luminari@ausl.re.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>IRCCS-Centro di Riferimento Oncologico - UO di ematologia e Trapianto Cellule Staminali</name>
        <address>
          <city>Rionero In Vulture</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Giuseppe Pietrantuono, MD</last_name>
        <email>ematologia45@alice.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>AO Sant' Andrea - Ematologia</name>
        <address>
          <city>Roma</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Agostino Tafuri, Prof.</last_name>
        <email>agostino.tafuri@ospedalesantandrea.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Policlinico Umberto I - Università &quot;La Sapienza&quot; - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione</name>
        <address>
          <city>Roma</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Alice Di Rocco, MD</last_name>
        <email>dirocco@bce.uniroma1.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare</name>
        <address>
          <city>Roma</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Luigi Rigacci, MD</last_name>
        <email>l.rigacci@policlinicocampus.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Istituto Clinico Humanitas - U.O. Ematologia</name>
        <address>
          <city>Rozzano</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Monica Balzarotti, MD</last_name>
        <email>monica.balzarotti@humanitas.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>AOU di Sassari - Ematologia</name>
        <address>
          <city>Sassari</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Claudio Fozza, Prof.</last_name>
        <email>cfozza@uniss.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico</name>
        <address>
          <city>Sassuolo</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Sara Bigliardi, MD</last_name>
        <email>s.bigliardi@ausl.mo.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>AOU Senese - U.O.C. Ematologia</name>
        <address>
          <city>Siena</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Alberto Fabbri, MD</last_name>
        <email>fabbri7@unisi.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ospedale &quot;G. Mazzini&quot; - UOS Ematologia</name>
        <address>
          <city>Teramo</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Angelo Fama, MD</last_name>
        <email>angelo.fama@aslteramo.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>A.O. S. Maria di Terni - S.C. Oncoematologia</name>
        <address>
          <city>Terni</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Anna Marina Liberati, Prof.</last_name>
        <email>marina.liberati@unipg.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria</name>
        <address>
          <city>Torino</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Federica Cavallo, MD</last_name>
        <email>f.cavallo@unito.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia</name>
        <address>
          <city>Torino</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Maura Nicolosi, MD</last_name>
        <email>manicolosi@cittadellasalute.to.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Ospedale Ca' Foncello - S.C di Ematologia</name>
        <address>
          <city>Treviso</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Elisabetta Scarpa, MD</last_name>
        <email>elisabetta.scarpa@aulss2.veneto.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>A.O. C. Panico - U.O.C Ematologia e Trapianto</name>
        <address>
          <city>Tricase</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Vincenzo Pavone, MD</last_name>
        <email>salentoematologia@piafondazionepanico.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia</name>
        <address>
          <city>Trieste</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Francesco Zaja, Prof.</last_name>
        <email>francesco.zaja@asugi.sanita.fvg.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica</name>
        <address>
          <city>Udine</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Jacopo Olivieri, MD</last_name>
        <email>jacopo.olivieri@asufc.sanita.fvg.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>AOU Integrata di Verona - U.O. Ematologia</name>
        <address>
          <city>Verona</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Carlo Visco, Prof.</last_name>
        <email>carlo.visco@univr.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>ULSS 8 Berica - Ospedale S. Bortolo - Ematologia</name>
        <address>
          <city>Vicenza</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Maria Chiara Tisi, MD</last_name>
        <email>mariachiara.tisi@aulss8.veneto.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Non-Hodgkin Lymphoma</keyword>
    <keyword>B-cell</keyword>
    <keyword>monoclonal antibodies</keyword>
    <keyword>novel antibodies</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma</mesh_term>
      <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
      <mesh_term>Lymphoma, B-Cell</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/NCT06008691
  org study id: FIL_MAB
  nct id: NCT06008691
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective, observational cohort study to evaluate the clinical impact of novel
        Monoclonal AntiBodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian clinical
        practice.
  This is a large prospective, observational cohort study aimed at collecting clinical
        information on use, feasibility, short- and long-term efficacy and short- and long-term
        toxicity of novel MAB that have received approval from EMA since 2020 and are prescribed
        according to the indications for use authorized for marketing in Italy.
  
        Patients entering the study will be subdivided into different cohorts based on approved
        treatment indications, type of antibody employed and histological subtype. Additional
        sub-cohorts will be defined if needed.
  
        Final outputs will be based according to:
  
          -  Per indication analysis;
  
          -  Pooled analyses by type of antibody and subtype and other parameters;
  
          -  A general analysis of the whole cohort.
  observational model: Cohort
  time perspective: Prospective
  measure: Overall response rate (ORR)
  time frame: At least 5 years
  description: ORR will be defined according to Lugano 2014 criteria as the proportion of patients who have a partial response (PR) or complete response to therapy (CR+PR).
  measure: Complete Response rate (CRR)
  time frame: At least 5 years
  description: CRR will be defined according to Lugano 2014 criteria and will include only patients who achieved a CR at the end of treatment program. The best overall response will be defined as the best response between the date of beginning of therapy and the last restaging. Patients without response assessment (due to whatever reason) will be considered as non-responders.
  measure: Progression free survival (PFS)
  time frame: At least 5 years
  description: PFS is defined as the time between the date of enrollment and the first documentation of recurrence, progression or death from any cause; responding patients and patients who are lost to follow up will be censored at their last assessment date.
  measure: Overall survival (OS)
  time frame: At least 5 years
  description: OS is defined as the time between the start of treatment until death from any cause; patients who are lost at follow up will be censored at their last assessment date.
  measure: Event free survival (EFS)
  time frame: At least 5 years
  description: ESFS is defined as the time from start of treatment to disease progression, death, or discontinuation of treatment for any reason (e.g. toxicity, patient preference), or initiation of a new treatment without documented progression.
  measure: Time-to-next treatment (TTNT)
  time frame: At least 5 years
  description: TTNT represents the interval from commencement of one treatment to initiation of the next line of therapy.
  measure: non-relapse mortality (NRM)
  time frame: At least 5 years
  description: NRM is defined as death without recurrent or progressive disease after treatment.
  measure: Duration of response (DOR)
  time frame: At least 5 years
  description: DOR is defined as the time from the first documentation of tumor response (CR/PR) to disease progression or death according to Lugano 2014 criteria.
  measure: Incidence of Early/Late Adverse Events
  time frame: At least 5 years
  description: Toxicities will be recorded and classified according to the definitions of the latest version of the NCI CTCAE. Toxicity events will be determined by the incidence of severe, life-threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (SAEs) commencing after the first induction dose or at any time during therapy. Early and toxic deaths and cause of any death. Special focus on second tumors, infections and autoimmune complications. Particularly:
  Hematological and extra-hematological toxicities Grade > 2
  Infusional adverse events, will be recorded any Grade
  Toxicities of specific interest on second tumors, infections and autoimmune complications will be recorded any Grade
  Early and toxic deaths and cause of any death.
  arm group label: B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA and AIFA).
  description: B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA since 2020 and prescribed according to the indications for use authorized for marketing in Italy).
  Patients first-line and relapsed or refractory who had received at least 1 dose of MAB.
  Different cohorts will be analyzed according to approved treatment indications, type of antibody employed and NHL hystotypes.
  intervention type: Drug
  intervention name: "novel" MAB (alone or in combination)
  description: "novel" MAB (alone or in combination) based on presence of an EMA clinical indication since 2020 and prescribed according to the indications for use authorized for marketing in Italy
  arm group label: B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA and AIFA).
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marco Ladetto, Prof.
  role: Principal Investigator
  affiliation: AO SS Antonio e Biagio e Cesare Arrigo, Alessandria
  last name: Uffici Studi FIL
  phone: +390131033153
  email: startup@filinf.it
  last name: Uffici Studi FIL
  phone: +390599769913
  email: gestionestudi@filinf.it
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  country: Italy
  responsible party type: Sponsor
  mesh term: Lymphoma
  mesh term: Lymphoma, Non-Hodgkin
  mesh term: Lymphoma, B-Cell