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/NCT05969743</url>
    </required_header>
    <id_info>
      <org_study_id>0827-22-RMC</org_study_id>
      <nct_id>NCT05969743</nct_id>
    </id_info>
    <brief_title>Letermovir Prophylaxis for Cytomegalovirus (CMV) in Patients With Graft-versus-host Disease</brief_title>
    <official_title>Letermovir Prophylaxis for CMV in Patients With Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation: a Proof of Concept Multicenter Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rabin Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rabin Medical Center</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Explore the tolerability and efficacy of letermovir in the prevention of CMV reactivation in&#xD;
        patients with acute and chronic graft-versus-host disease (GVHD) beyond day 100.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        42 patients meeting the inclusion criteria will receive letermovir 480 mg per day. Patients&#xD;
        receiving concomitant cyclosporine will receive 240 mg of letermovir. Letermovir will be&#xD;
        given during 14 weeks or until prednisone dose is reduced below 0.2 mg / kg / day, whichever&#xD;
        comes earlier.&#xD;
  &#xD;
        All the patients will continue herpesvirus prophylaxis with acyclovir or valacyclovir.&#xD;
  &#xD;
        Patients will be evaluated biweekly until letermovir discontinuation. A PCR CMV test will be&#xD;
        performed biweekly. Patients in whom clinically significant CMV infection (defined as CMV&#xD;
        disease or CMV viremia leading to preemptive treatment) develop, will discontinue the trial&#xD;
        regimen and begin anti-CMV therapy according to local practice. The threshold for preemptive&#xD;
        treatment for CMV viremia will be &gt;1000 copies/ ml.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 30, 2025</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of CMV infection</measure>
      <time_frame>14 weeks</time_frame>
      <description>The proportion of patients with clinically significant CMV infection through week 14 after enrollment or until prednisone dose is reduced below 0.2 mg / kg / day, whichever comes earlier.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">42</enrollment>
    <condition>Graft-versus-host-disease</condition>
    <condition>CMV</condition>
    <arm_group>
      <arm_group_label>Letermovir</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients meeting the inclusion criteria will receive letermovir 480 mg per day. Patients receiving concomitant cyclosporine will receive 240 mg of letermovir. Letermovir will be given during 14 weeks or until prednisone dose is reduced below 0.2 mg / kg / day, whichever comes earlier.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Letermovir</intervention_name>
      <description>Patients meeting the inclusion criteria will receive letermovir 480 mg per day. Patients receiving concomitant cyclosporine will receive 240 mg of letermovir. Letermovir will be given during 14 weeks or until prednisone dose is reduced below 0.2 mg / kg / day, whichever comes earlier.</description>
      <arm_group_label>Letermovir</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients&#xD;
  &#xD;
            -  After allogeneic transplantation&#xD;
  &#xD;
            -  Seropositive for CMV&#xD;
  &#xD;
            -  Who already received letermovir prophylaxis until day 100 without CMV reactivation&#xD;
  &#xD;
            -  Beyond day 100 after transplantation at enrollment&#xD;
  &#xD;
            -  With acute or chronic GVHD&#xD;
  &#xD;
            -  Daily prednisone dose ≥ 0.5 mg/kg (or equivalent dose of another glucocorticoid) at&#xD;
               enrollment.&#xD;
  &#xD;
            -  Negative polymerase chain reaction (PCR) for CMV at enrollment&#xD;
  &#xD;
            -  Provided informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Seronegative for CMV&#xD;
  &#xD;
            -  Positive PCR for CMV at enrollment&#xD;
  &#xD;
            -  Patient has previously had CMV reactivation under letermovir.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>120 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Moshe Yeshurun, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Institution of Hematology, Rabin Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Moshe Yeshurun, MD</last_name>
      <phone>0526015543</phone>
      <email>moshe.yeshurun@gmail.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 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>Graft vs Host Disease</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Letermovir</mesh_term>
    </intervention_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/NCT05969743
  org study id: 0827-22-RMC
  nct id: NCT05969743
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Explore the tolerability and efficacy of letermovir in the prevention of CMV reactivation in
        patients with acute and chronic graft-versus-host disease (GVHD) beyond day 100.
  42 patients meeting the inclusion criteria will receive letermovir 480 mg per day. Patients
        receiving concomitant cyclosporine will receive 240 mg of letermovir. Letermovir will be
        given during 14 weeks or until prednisone dose is reduced below 0.2 mg / kg / day, whichever
        comes earlier.
  
        All the patients will continue herpesvirus prophylaxis with acyclovir or valacyclovir.
  
        Patients will be evaluated biweekly until letermovir discontinuation. A PCR CMV test will be
        performed biweekly. Patients in whom clinically significant CMV infection (defined as CMV
        disease or CMV viremia leading to preemptive treatment) develop, will discontinue the trial
        regimen and begin anti-CMV therapy according to local practice. The threshold for preemptive
        treatment for CMV viremia will be >1000 copies/ ml.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Incidence of CMV infection
  time frame: 14 weeks
  description: The proportion of patients with clinically significant CMV infection through week 14 after enrollment or until prednisone dose is reduced below 0.2 mg / kg / day, whichever comes earlier.
  arm group label: Letermovir
  arm group type: Experimental
  description: Patients meeting the inclusion criteria will receive letermovir 480 mg per day. Patients receiving concomitant cyclosporine will receive 240 mg of letermovir. Letermovir will be given during 14 weeks or until prednisone dose is reduced below 0.2 mg / kg / day, whichever comes earlier.
  intervention type: Drug
  intervention name: Letermovir
  description: Patients meeting the inclusion criteria will receive letermovir 480 mg per day. Patients receiving concomitant cyclosporine will receive 240 mg of letermovir. Letermovir will be given during 14 weeks or until prednisone dose is reduced below 0.2 mg / kg / day, whichever comes earlier.
  arm group label: Letermovir
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 120 Years
  healthy volunteers: No
  last name: Moshe Yeshurun, MD
  role: Principal Investigator
  affiliation: Institution of Hematology, Rabin Medical Center
  last name: Moshe Yeshurun, MD
  phone: 0526015543
  email: moshe.yeshurun@gmail.com
  responsible party type: Sponsor
  mesh term: Graft vs Host Disease
  mesh term: Letermovir
  sharing ipd: No