<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/NCT02227797</url>
  </required_header>
  <id_info>
    <org_study_id>2013LS126</org_study_id>
    <secondary_id>MT2013-37R</secondary_id>
    <nct_id>NCT02227797</nct_id>
  </id_info>
  <brief_title>MT2013-37R: Voriconazole Monitoring in Pediatric Stem Cell Transplant Patients</brief_title>
  <official_title>MT2013-37R: Voriconazole Therapeutic Drug Monitoring in Pediatric Hematopoietic Stem Cell Transplant Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Masonic Cancer Center, University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Masonic Cancer Center, University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of this study is to identify the optimal dose of voriconazole, an&#xD;
      anti-fungal drug often used in people undergoing stem cell transplant. An optimal dose level&#xD;
      is one level that provides a good blood level (concentration) of voriconazole without too&#xD;
      much toxicity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2015</start_date>
  <completion_date type="Actual">March 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 8, 2017</primary_completion_date>
  <phase>Phase 1</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>Maximum tolerated, minimum efficacious dose for 3 different pediatric age groups</measure>
    <time_frame>Seven days after starting voriconazole</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of initial dose of voriconazole with voriconazole blood concentration in 3 different pediatric age groups</measure>
    <time_frame>After starting voriconazole: Day 5, between Days 12-15, between Days 19-22</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of voriconazole dose with elevations to 5 times the upper limit of normal in liver enzymes</measure>
    <time_frame>After starting voriconazole: Twice a week Days 1-30 and 1 week after the last dose of voriconazole ~ Day 35-42</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of fungal infection</measure>
    <time_frame>6-month period after transplant</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Fungal Infection</condition>
  <arm_group>
    <arm_group_label>Voriconazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Voriconazole</intervention_name>
    <description>6 mg/kg to 12 mg/kg IV/PO every 12 hours depending on patient age and dose toleration of prior patients</description>
    <arm_group_label>Voriconazole</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient undergoing allogeneic hematopoietic stem cell transplantation (either 1st&#xD;
             or subsequent)&#xD;
&#xD;
          -  Age ≤ 21 years&#xD;
&#xD;
          -  Adequate organ function within 14 days of enrollment, i.e. Creatinine: &lt; 1.5 x ULN and&#xD;
             Hepatic: ALT, AST and total bilirubin &lt; 3 x ULN&#xD;
&#xD;
          -  Requires voriconazole to prevent or treat invasive fungal infection after undergoing&#xD;
             stem cell transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has received voriconazole within 5 days prior to starting study therapy&#xD;
&#xD;
          -  History of hypersensitivity or severe intolerance to azoles&#xD;
&#xD;
          -  History, or current evidence, of cardiac arrhythmias defined as QTc ≥ 480 mm/sec&#xD;
&#xD;
          -  Receiving the following drugs and cannot be discontinued at least 24 hours before&#xD;
             starting therapy: pimozide, quinidine, astemizole, ergot alkaloids.&#xD;
&#xD;
          -  Received one or more of the following drugs within 14 days prior to starting study, as&#xD;
             they are potent inducers of hepatic microsomal enzymes: rifampin, rifabutin,&#xD;
             carbamazepine, phenytoin, nevirapine, long-acting barbiturates.&#xD;
&#xD;
          -  Received sirolimus within the 14 days prior to starting study as voriconazole is a&#xD;
             potent inhibitor of sirolimus metabolism&#xD;
&#xD;
          -  Receiving or anticipated need for methadone as co-administration with voriconazole&#xD;
             potentially increases methadone exposure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Angela Smith, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Masonic Cancer Center, University of Minnesota</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pui-Yang Iroh Tam, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Masonic Cancer Center, Univeristy of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Minnesota Medical Center, Fairview</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>April 26, 2019</last_update_submitted>
  <last_update_submitted_qc>April 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stem cell transplant</keyword>
  <keyword>hematopoietic stem cell transplant</keyword>
  <keyword>fungal infection</keyword>
  <keyword>voriconazole</keyword>
  <keyword>pediatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mycoses</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Voriconazole</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/NCT02227797
org study id: 2013LS126
secondary id: MT2013-37R
nct id: NCT02227797
lead sponsor: 
has dmc: No
The primary purpose of this study is to identify the optimal dose of voriconazole, an
      anti-fungal drug often used in people undergoing stem cell transplant. An optimal dose level
      is one level that provides a good blood level (concentration) of voriconazole without too
      much toxicity.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum tolerated, minimum efficacious dose for 3 different pediatric age groups
time frame: Seven days after starting voriconazole
measure: Correlation of initial dose of voriconazole with voriconazole blood concentration in 3 different pediatric age groups
time frame: After starting voriconazole: Day 5, between Days 12-15, between Days 19-22
measure: Correlation of voriconazole dose with elevations to 5 times the upper limit of normal in liver enzymes
time frame: After starting voriconazole: Twice a week Days 1-30 and 1 week after the last dose of voriconazole ~ Day 35-42
measure: Incidence of fungal infection
time frame: 6-month period after transplant
arm group label: Voriconazole
arm group type: Experimental
intervention type: Drug
intervention name: Voriconazole
description: 6 mg/kg to 12 mg/kg IV/PO every 12 hours depending on patient age and dose toleration of prior patients
arm group label: Voriconazole
criteria: 
gender: All
minimum age: N/A
maximum age: 21 Years
healthy volunteers: No
last name: Angela Smith, M.D.
role: Principal Investigator
affiliation: Masonic Cancer Center, University of Minnesota
last name: Pui-Yang Iroh Tam, M.D.
role: Principal Investigator
affiliation: Masonic Cancer Center, Univeristy of Minnesota
facility: 
country: United States
responsible party type: Sponsor
mesh term: Mycoses
mesh term: Voriconazole