<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/NCT03804372</url>
  </required_header>
  <id_info>
    <org_study_id>CLL1818</org_study_id>
    <nct_id>NCT03804372</nct_id>
  </id_info>
  <brief_title>The Incidence of Hepatitis B in Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide</brief_title>
  <acronym>CLL1818</acronym>
  <official_title>Prospective Study on the Incidence of Hepatitis B Virus Reactivation in Untreated Patients With Diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive Treated With Rituximab, Chemotherapy and Tenofovir Alafenamide</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>
      In this study, we will evaluate the incidence of hepatitis B virus reactivation within the&#xD;
      first 6 months of treatment with rituximab, standard chemotherapy and TAF in patients with&#xD;
      diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multicenter, interventional, single arm, evaluating the incidence of&#xD;
      hepatitis B virus (HBV) reactivation within the first 6 months treatment period in HBsAg&#xD;
      positive patients treated for DLBCL/Chronic Lymphoid Leukemia with Rituximab, standard&#xD;
      chemotherapy, and TAF.&#xD;
&#xD;
      Approximate duration of the recruitment period based on the number of patients available The&#xD;
      duration of the recruitment period has been estimated at 12 months.&#xD;
&#xD;
      Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy&#xD;
      for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy&#xD;
      and withdrawn 12 months after the completion of chemotherapy. Then patients will be also&#xD;
      observed for further12 months&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients presenting hepatitis B virus reactivation</measure>
    <time_frame>Within 6 months following the start of treatment</time_frame>
    <description>Assessment of the percentage of patients presenting HBV reactivation within 6 months following the start of treatment with Rituximab, chemotherapy and TAF in in DLBCL and Chronic Lymphoid Leukemia patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients presenting hepatitis B virus reactivation</measure>
    <time_frame>After 12 months following the study entry and start of treatment</time_frame>
    <description>Assessment of the percentage of patients presenting HBV reactivation during and after the 12-month treatment of TAF as a single agent in in DLBCL and Chronic Lymphoid Leukemia patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients stratified by DLBCL and Chronic Lymphoid Leukemia with hepatitis related to the HBV infection or with liver failure during their participation in the study.</measure>
    <time_frame>After 31 months from study entry</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients in which chemotherapy is delayed due to HBV-reactivation.</measure>
    <time_frame>After 31 months from study entry</time_frame>
    <description>In terms of percentage of patients with a delay of at least 7 days between chemotherapy cycles stratified by DLBCL and chronic lymphoid leukemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with DLBCL and with Chronic Lymphoid Leukemia who survive</measure>
    <time_frame>After 31 months from study entry</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients experiencing adverse events.</measure>
    <time_frame>After 31 months from study entry</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Large-B-cell Diffuse Lymphoma</condition>
  <condition>Chronic Lymphoid Leukemia</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chemotherapy</intervention_name>
    <description>Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir alafenamide</intervention_name>
    <description>Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed written informed consent according to ICH/EU/GCP and national local laws.&#xD;
&#xD;
          -  Male/non-pregnant/non-lactating female subjects &gt;18 years old with newly diagnosed&#xD;
             DLBCL/Chronic Lymphoid Leukemia who are going to receive treatment with rituximab in&#xD;
             combination with chemotherapy.&#xD;
&#xD;
          -  HBsAg positivity, serum HBV-DNA negative or positive (&lt;2000/IU), and normal liver&#xD;
             function, including alanine aminotransferase(ALT), aspartate aminotransferase(AST) and&#xD;
             bilirubin. (inactive carriers).&#xD;
&#xD;
          -  No previous treatment with antiviral drugs for HBV infection.&#xD;
&#xD;
          -  Patients with satisfactory renal function.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hepatic insufficiency for any reason&#xD;
&#xD;
          -  History of other liver diseases such as hepatitis C, D, autoimmune hepatitis, primary&#xD;
             biliary cirrhosis, Wilsons' disease&#xD;
&#xD;
          -  Positive viral markers, such as IgM antibody to hepatitis A virus, hepatitis C virus,&#xD;
             IgG antibody to hepatitis D virus, IgM antibody to hepatitis E virus, or antibody to&#xD;
             HIV&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Other major systemic diseases, such as active infection, significant cardiac disease,&#xD;
             neurological deficit or psychiatric disorder, that the investigators consider being a&#xD;
             significant risk&#xD;
&#xD;
          -  Patients with moderate or severe renal failure.&#xD;
&#xD;
          -  Intolerance to any of the components of the therapeutic regimen. Treatment with any&#xD;
             investigational medicinal product (unapproved) in the last 30 days.&#xD;
&#xD;
          -  Any other disorder that, in the investigator's opinion, makes the patient ineligible&#xD;
             for recruitment or that could interfere in his/her participation or in the conclusion&#xD;
             of the study.&#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>Giuseppe Gentile</last_name>
    <role>Study Chair</role>
    <affiliation>Università Sapienza di Roma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alessandra Micozzi</last_name>
    <role>Study Director</role>
    <affiliation>Università Sapienza di Roma</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paola Fazi</last_name>
    <phone>+39 0670390514</phone>
    <email>p.fazi@gimema.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Enrico Crea</last_name>
    <phone>+39 0670390514</phone>
    <email>e.crea@gimema.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Università degli Studi &quot;Sapienza&quot; - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia</name>
      <address>
        <city>Roma</city>
        <state>(rm)</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giuseppe Gentile</last_name>
    </contact>
    <investigator>
      <last_name>Giuseppe Gentile</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alessandra Micozzi</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia</name>
      <address>
        <city>Alessandria</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniela Pietrasanta</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aou Ospedali Riuniti &quot;Umberto I - G.M. Lancisi - G. Salesi&quot;- Ancona - Sod Clinica Ematologica</name>
      <address>
        <city>Ancona</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guido Gini</last_name>
      <email>guido.gini@ospedaliriunitimarche.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le &quot;C.G.Mazzoni&quot; - Uoc Ematologia</name>
      <address>
        <city>Ascoli Piceno</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Piero Galieni</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Irccs Centro Di Riferimento Oncologico Di Aviano - Sosd Oncoematologia Trapianti Emopoietici E Terapie Cellulari</name>
      <address>
        <city>Aviano</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emanuela Chimienti</last_name>
      <email>echimienti@cro.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto</name>
      <address>
        <city>Bari</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francesco C Albano</last_name>
      <email>francesco.albano@uniba.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia</name>
      <address>
        <city>Bari</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Attilio Guarini</last_name>
      <email>attilioguarini@oncologico.bari.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Asl Brindisi, Ospedale 'Perrino' - Brindisi - Uo Ematologia</name>
      <address>
        <city>Brindisi</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Domenico Pastore</last_name>
      <email>domenico.pastore0@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania</name>
      <address>
        <city>Catania</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francesco Di Raimondo</last_name>
      <phone>3284782450</phone>
      <email>diraimon@unict.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione</name>
      <address>
        <city>Cona</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antonio Cuneo</last_name>
      <email>cut@unife.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aou Ospedali Riuniti - Foggia - Uoc Ematologia</name>
      <address>
        <city>Foggia</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vincenza Fernanda Fesce</last_name>
      <email>cinzia.fesce@libero.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia</name>
      <address>
        <city>Lecce</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicola Di Renzo</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ao Ospedali Riuniti &quot;Papardo Piemonte&quot; - Po Papardo - Messina - Sc Ematologia</name>
      <address>
        <city>Messina</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Donato Mannina</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Felicetto Ferrara</last_name>
      <email>felicettoferrara@katamail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aou Federico Ii - Napoli - Uoc Ematologia</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fabrizio Pane</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aou Maggiore Della Carita' Di Novara - Scdu Ematologia</name>
      <address>
        <city>Novara</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gianluca Gaidano</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia</name>
      <address>
        <city>Pagani</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catello Califano</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo</name>
      <address>
        <city>Palermo</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caterina Patti</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia</name>
      <address>
        <city>Pavia</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luca U Arcaini</last_name>
      <email>luca.arcaini@unipv.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica</name>
      <address>
        <city>Pescara</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elsa Pennese</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia</name>
      <address>
        <city>Reggio Emilia</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fiorella Ilariucci</last_name>
      <email>Fiorella.Ilariucci@ausl.re.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ausl Della Romagna, Ospedale &quot;Infermi&quot; - Rimini - Uo Ematologia</name>
      <address>
        <city>Rimini</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anna Merli</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ao San Camillo Forlanini - Roma - Uoc Ematologia E Trapianto Cellule Staminali</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roberta Battistini</last_name>
      <email>rbattistini@scamilloforlanini.rm.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Cantonetti</last_name>
      <email>cantonetti@med.uniroma2.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aou Sant'Andrea - Roma - Uoc Ematologia</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Agostino Tafuri</last_name>
      <phone>3392145880</phone>
      <email>agostino.tafuri@ospedalesantandrea.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paolo De Fabritiis</last_name>
      <email>paolo.de.fabritiis@uniroma2.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luca Laurenti</last_name>
      <email>luca.laurenti@Unicatt.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia</name>
      <address>
        <city>San Giovanni Rotondo</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicola Cascavilla</last_name>
      <email>n.cascavilla@operapadrepio.it</email>
    </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>Marta Coscia</last_name>
      <email>marta.coscia@unito.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia</name>
      <address>
        <city>Verona</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carlo Visco</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>
      <email>mariachiara.tisi@aulss8.veneto.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 3, 2022</last_update_submitted>
  <last_update_submitted_qc>January 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diffuse Large B-Cell Lymphoma</keyword>
  <keyword>chronic Lymphoid Leukemia HBsAg-positive</keyword>
  <keyword>Rituximab</keyword>
  <keyword>chemotherapy</keyword>
  <keyword>alafenamide</keyword>
  <keyword>hepatitis B virus reactivation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Rituximab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03804372
org study id: CLL1818
nct id: NCT03804372
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, we will evaluate the incidence of hepatitis B virus reactivation within the
      first 6 months of treatment with rituximab, standard chemotherapy and TAF in patients with
      diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive.
This is a prospective, multicenter, interventional, single arm, evaluating the incidence of
      hepatitis B virus (HBV) reactivation within the first 6 months treatment period in HBsAg
      positive patients treated for DLBCL/Chronic Lymphoid Leukemia with Rituximab, standard
      chemotherapy, and TAF.

      Approximate duration of the recruitment period based on the number of patients available The
      duration of the recruitment period has been estimated at 12 months.

      Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy
      for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy
      and withdrawn 12 months after the completion of chemotherapy. Then patients will be also
      observed for further12 months
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients presenting hepatitis B virus reactivation
time frame: Within 6 months following the start of treatment
description: Assessment of the percentage of patients presenting HBV reactivation within 6 months following the start of treatment with Rituximab, chemotherapy and TAF in in DLBCL and Chronic Lymphoid Leukemia patients.
measure: Percentage of patients presenting hepatitis B virus reactivation
time frame: After 12 months following the study entry and start of treatment
description: Assessment of the percentage of patients presenting HBV reactivation during and after the 12-month treatment of TAF as a single agent in in DLBCL and Chronic Lymphoid Leukemia patients
measure: Number of patients stratified by DLBCL and Chronic Lymphoid Leukemia with hepatitis related to the HBV infection or with liver failure during their participation in the study.
time frame: After 31 months from study entry
measure: Percentage of patients in which chemotherapy is delayed due to HBV-reactivation.
time frame: After 31 months from study entry
description: In terms of percentage of patients with a delay of at least 7 days between chemotherapy cycles stratified by DLBCL and chronic lymphoid leukemia.
measure: Number of patients with DLBCL and with Chronic Lymphoid Leukemia who survive
time frame: After 31 months from study entry
measure: Number of patients experiencing adverse events.
time frame: After 31 months from study entry
arm group label: Study group
arm group type: Experimental
description: Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.
intervention type: Drug
intervention name: Rituximab
description: Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.
arm group label: Study group
intervention type: Drug
intervention name: Chemotherapy
description: Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.
arm group label: Study group
intervention type: Drug
intervention name: Tenofovir alafenamide
description: Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.
arm group label: Study group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Giuseppe Gentile
role: Study Chair
affiliation: Università Sapienza di Roma
last name: Alessandra Micozzi
role: Study Director
affiliation: Università Sapienza di Roma
last name: Paola Fazi
phone: +39 0670390514
email: p.fazi@gimema.it
last name: Enrico Crea
phone: +39 0670390514
email: e.crea@gimema.it
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country: Italy
responsible party type: Sponsor
mesh term: Hepatitis B
mesh term: Lymphoma
mesh term: Leukemia
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell
mesh term: Lymphoma, Non-Hodgkin
mesh term: Hepatitis
mesh term: Tenofovir
mesh term: Rituximab
sharing ipd: No