<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/NCT04478474</url>
  </required_header>
  <id_info>
    <org_study_id>14151</org_study_id>
    <nct_id>NCT04478474</nct_id>
  </id_info>
  <brief_title>Cytomegalovirus (CMV) Viremia and Disease Occurrence in Pediatric Allogeneic Stem Cell Transplantation Recipients</brief_title>
  <official_title>Cytomegalovirus (CMV) Viremia and Disease Occurrence in Pediatric Allogeneic Stem Cell Transplantation Recipients Following Ganciclovir Prophylaxis Until Day +100</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>New York Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>New York Medical College</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective is to determine the incidence of CMV viremia and disease in pediatric&#xD;
      allogeneic stem cell transplantation recipients who received ganciclovir prophylaxis up until&#xD;
      day +100 by retrospective analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a single center, retrospective chart review of all pediatric patients who&#xD;
      underwent allogeneic stem cell transplant between June 29, 2011 and December 31, 2019 at&#xD;
      Westchester Medical Center (WMC). For this analysis, eligible patients will be identified&#xD;
      through our transplantation database and clinical data collected through electronic medical&#xD;
      record. This analysis will comprise of 100 pediatric allogeneic stem cell transplant&#xD;
      recipients. CMV viremia will be defined as ≥2 CMV positive PCRs ≥500 copies and CMV disease&#xD;
      will be defined as isolation of CMV in any body fluid or tissue specimen along with end-organ&#xD;
      disease, as we have demonstrated.8 CMV viremia/disease will be evaluated through day +100&#xD;
      following allogeneic stem cell transplantation. Review of clinical records and collection of&#xD;
      data with de-identified information will be performed. The study team will not access medical&#xD;
      records (paper or electronic) directly. Medical records will be obtained through the&#xD;
      Hospital's Health Information Management (HIM) department. HIM will query requested data /&#xD;
      variables and provide a report / records of interest to Investigator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2020</start_date>
  <completion_date type="Actual">September 15, 2022</completion_date>
  <primary_completion_date type="Actual">December 15, 2021</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ganciclovir</measure>
    <time_frame>June 29, 2011 through December 31, 2019</time_frame>
    <description>Ganciclovir will be safe, well tolerated, and effective to prevent CMV viremia and/or decrease in pediatric allogeneic stem cell transplant recipients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CMV viremia and disease in pediatric allogenic SCT recipients</measure>
    <time_frame>June 29, 2011 through December 31, 2019</time_frame>
    <description>The primary objective is to determine the incidence of CMV viremia and disease in pediatric allogeneic stem cell transplantation recipients who received ganciclovir prophylaxis up until day +100 by retrospective analysis.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Cytomegalovirus Infections</condition>
  <arm_group>
    <arm_group_label>Eligible</arm_group_label>
    <description>Retrospective chart review of all pediatric patients who underwent allogeneic stem cell transplant between June 29, 2011 and December 31, 2019 at Westchester Medical Center (WMC). Children, adolescent, and young adult patients, ages 0-≤26 years, who have received an allogeneic stem cell transplantation on the pediatric bone marrow transplant service including matched unrelated donor, matched sibling donor, haploidentical donor, umbilical cord donor, who received ganciclovir prophylaxis for ≥14 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ganciclovir</intervention_name>
    <description>Type of allogeneic transplant, HLA match, graft manipulation, use of ATG and/or Campath, CMV status (donor and recipient), maximal acute GVHD stage and grade, CMV viremia/disease through day +100, days received ganciclovir prophylaxis, adverse events related directly or secondary to ganciclovir prophylaxis.</description>
    <arm_group_label>Eligible</arm_group_label>
    <other_name>allogenic stem cell tranplatation</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children, adolescent, and young adult patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Retrospective chart review of all pediatric patients who underwent allogeneic stem&#xD;
             cell transplant between June 29, 2011 and December 31, 2019 at Westchester Medical&#xD;
             Center (WMC).&#xD;
&#xD;
          -  ages 0-≤26 years&#xD;
&#xD;
          -  received an allogeneic stem cell transplantation on the pediatric bone marrow&#xD;
             transplant service including matched unrelated donor, matched sibling donor,&#xD;
             haploidentical donor, umbilical cord donor&#xD;
&#xD;
          -  received ganciclovir prophylaxis for ≥14 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None listed&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>New York Medical College</name>
      <address>
        <city>Valhalla</city>
        <state>New York</state>
        <zip>10595</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>October 24, 2022</last_update_submitted>
  <last_update_submitted_qc>October 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2022</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>Cytomegalovirus Infections</mesh_term>
    <mesh_term>Viremia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ganciclovir</mesh_term>
    <mesh_term>Ganciclovir triphosphate</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04478474
org study id: 14151
nct id: NCT04478474
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The primary objective is to determine the incidence of CMV viremia and disease in pediatric
      allogeneic stem cell transplantation recipients who received ganciclovir prophylaxis up until
      day +100 by retrospective analysis.
This will be a single center, retrospective chart review of all pediatric patients who
      underwent allogeneic stem cell transplant between June 29, 2011 and December 31, 2019 at
      Westchester Medical Center (WMC). For this analysis, eligible patients will be identified
      through our transplantation database and clinical data collected through electronic medical
      record. This analysis will comprise of 100 pediatric allogeneic stem cell transplant
      recipients. CMV viremia will be defined as ≥2 CMV positive PCRs ≥500 copies and CMV disease
      will be defined as isolation of CMV in any body fluid or tissue specimen along with end-organ
      disease, as we have demonstrated.8 CMV viremia/disease will be evaluated through day +100
      following allogeneic stem cell transplantation. Review of clinical records and collection of
      data with de-identified information will be performed. The study team will not access medical
      records (paper or electronic) directly. Medical records will be obtained through the
      Hospital's Health Information Management (HIM) department. HIM will query requested data /
      variables and provide a report / records of interest to Investigator.
observational model: Cohort
time perspective: Retrospective
measure: Ganciclovir
time frame: June 29, 2011 through December 31, 2019
description: Ganciclovir will be safe, well tolerated, and effective to prevent CMV viremia and/or decrease in pediatric allogeneic stem cell transplant recipients.
measure: CMV viremia and disease in pediatric allogenic SCT recipients
time frame: June 29, 2011 through December 31, 2019
description: The primary objective is to determine the incidence of CMV viremia and disease in pediatric allogeneic stem cell transplantation recipients who received ganciclovir prophylaxis up until day +100 by retrospective analysis.
arm group label: Eligible
description: Retrospective chart review of all pediatric patients who underwent allogeneic stem cell transplant between June 29, 2011 and December 31, 2019 at Westchester Medical Center (WMC). Children, adolescent, and young adult patients, ages 0-≤26 years, who have received an allogeneic stem cell transplantation on the pediatric bone marrow transplant service including matched unrelated donor, matched sibling donor, haploidentical donor, umbilical cord donor, who received ganciclovir prophylaxis for ≥14 days.
intervention type: Drug
intervention name: Ganciclovir
description: Type of allogeneic transplant, HLA match, graft manipulation, use of ATG and/or Campath, CMV status (donor and recipient), maximal acute GVHD stage and grade, CMV viremia/disease through day +100, days received ganciclovir prophylaxis, adverse events related directly or secondary to ganciclovir prophylaxis.
arm group label: Eligible
other name: allogenic stem cell tranplatation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 26 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cytomegalovirus Infections
mesh term: Viremia
mesh term: Ganciclovir
mesh term: Ganciclovir triphosphate