<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/NCT03823950</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0082</org_study_id>
    <nct_id>NCT03823950</nct_id>
  </id_info>
  <brief_title>Starting Granulocyte Colony-Stimulating Factor at 1 Day vs 3 Days Following Chemotherapy in Pediatric Cancer Patients</brief_title>
  <official_title>A Pilot Study of Granulocyte Colony-Stimulating Factor Starting at 24 Hours vs 72 Hours in Pediatric Oncology Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Mississippi Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Mississippi Medical Center</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>
      Chemotherapy places patients at an increased risk of infection. A medication called&#xD;
      granulocyte colony-stimulating factor is given as a daily injection in order to help decrease&#xD;
      the risk of infection. The purpose of this study is to determine the best time to begin&#xD;
      granulocyte colony-stimulating factor while maintaining the same clinical benefits. The&#xD;
      current study aims to fill these research gaps and address the general question: Can G-CSF&#xD;
      safely be given 72 hours following the last day of chemotherapy without increasing the&#xD;
      incidence of febrile neutropenia, the duration of neutropenia, or causing increased delays in&#xD;
      the next course of chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of hospital admissions for febrile neutropenia</measure>
    <time_frame>From date of completion of course of chemotherapy until date of the initiation of next chemotherapy course, assessed up to 1 year</time_frame>
    <description>Febrile neutropenia is defined as a temperature greater than or equal to 38 degrees Celsius and ANC less than or equal to 500</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of neutropenia</measure>
    <time_frame>From date of first recorded ANC following chemotherapy until date of first ANC that is greater than 500 following nadir, assessed up to 1 year</time_frame>
    <description>The number of days between the first documented ANC less than or equal to 500 and the first documented ANC greater than 500 following nadir</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days delayed in beginning the next course of chemotherapy</measure>
    <time_frame>Will be assessed weekly until the next course of chemotherapy is initiated, up to 1 year</time_frame>
    <description>A delay in chemotherapy is defined when the initiation of the next course of chemotherapy is delayed due to neutropenia</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Needle distress</measure>
    <time_frame>2 days</time_frame>
    <description>Distress Rating Tool: The DRS version for 2-, 3-, and 4-year-olds has three faces with different facial expressions for children to point to the one that best matches how they feel. The version for 5- and 6-year-olds has a visual analog scale presented as a thermometer with a happy face drawn next to the 0 and a sad face drawn next to the 10. The DRT version for youth 7 to 18 years defines distress as 'worry, anxiety, sadness, or fear,' on a scale from 0 (no distress) to 5 (moderate distress) to 10 (high distress). The adult DRS will be used for youth 19 to 21 years. Caregivers will rate their perception of their child's distress</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical Side Effects</measure>
    <time_frame>1 week</time_frame>
    <description>Memorial Symptom Assessment Scale: Physical and psychological symptoms; 8 items on 3-4 point scale (7-12 yrs) during past 2 days; 22 items on 4-5 point scale (10-14 yrs) during past week</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Granulocyte Colony-Stimulating Factor</condition>
  <condition>Chemotherapy-induced Neutropenia</condition>
  <condition>Chemotherapy-Induced Febrile Neutropenia</condition>
  <condition>Pediatric Cancer</condition>
  <arm_group>
    <arm_group_label>Receive G-CSF 72 hours following chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children will be enrolled during the first four rounds of chemotherapy. Upon enrollment, children will receive G-CSF at 24 hours following chemotherapy. G-CSF will be discontinued when absolute neutrophil count (ANC) has increased post nadir in accord with G-CSF administration guidelines. Parents and children will then complete questionnaires to determine rates of side effects and needle distress at the end of G-CSF during their next regular outpatient oncology clinic visit.&#xD;
Following children's next course of chemotherapy, G-CSF will be started 72 hours after completion of chemotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Historical Controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Four matched historical controls who received G-CSF at 24 hours following chemotherapy for each patient enrolled will be selected as each enrolled patient completes G-CSF therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Granulocyte Colony-Stimulating Factor</intervention_name>
    <description>Begin G-CSF 72 hours following chemotherapy</description>
    <arm_group_label>Receive G-CSF 72 hours following chemotherapy</arm_group_label>
    <other_name>G-CSF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric oncology patients will be eligible to participate in this study if they meet&#xD;
             the following inclusion criteria:&#xD;
&#xD;
               1. are between the ages of birth and 21 years old&#xD;
&#xD;
               2. is diagnosed with an oncologic disease&#xD;
&#xD;
               3. is being treated at UMMC Children's Cancer Clinic&#xD;
&#xD;
               4. will receive G-CSF as part of their standard or experimental oncology treatment&#xD;
                  protocol between January 1, 2019 and December 31, 2019. Oncology treatment&#xD;
                  protocols are typically derived from the Children's Oncology Group standard of&#xD;
                  care or patients can be enrolled on a Children's Oncology Group treatment study.&#xD;
&#xD;
               5. is within first four courses of chemotherapy treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded from the current study if:&#xD;
&#xD;
               1. G-CSF was added to their oncology treatment protocol due to previous&#xD;
                  complications but for whom G-CSF was not part of their original treatment&#xD;
                  protocol.&#xD;
&#xD;
               2. are being treated for relapsed disease&#xD;
&#xD;
               3. has clinical evidence of bone marrow involvement&#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>Anderson B Collier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Mississippi Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anderson B Collier, MD</last_name>
    <phone>601-984-5221</phone>
    <email>acollier@umc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Univeristy of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessica M Seaborn, MD</last_name>
      <phone>601-984-5221</phone>
      <email>jseaborn@umc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>March 11, 2020</last_update_submitted>
  <last_update_submitted_qc>March 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2020</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>Neutropenia</mesh_term>
    <mesh_term>Febrile Neutropenia</mesh_term>
    <mesh_term>Chemotherapy-Induced Febrile Neutropenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenograstim</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/NCT03823950
org study id: 2018-0082
nct id: NCT03823950
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Chemotherapy places patients at an increased risk of infection. A medication called
      granulocyte colony-stimulating factor is given as a daily injection in order to help decrease
      the risk of infection. The purpose of this study is to determine the best time to begin
      granulocyte colony-stimulating factor while maintaining the same clinical benefits. The
      current study aims to fill these research gaps and address the general question: Can G-CSF
      safely be given 72 hours following the last day of chemotherapy without increasing the
      incidence of febrile neutropenia, the duration of neutropenia, or causing increased delays in
      the next course of chemotherapy.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Incidence of hospital admissions for febrile neutropenia
time frame: From date of completion of course of chemotherapy until date of the initiation of next chemotherapy course, assessed up to 1 year
description: Febrile neutropenia is defined as a temperature greater than or equal to 38 degrees Celsius and ANC less than or equal to 500
measure: Duration of neutropenia
time frame: From date of first recorded ANC following chemotherapy until date of first ANC that is greater than 500 following nadir, assessed up to 1 year
description: The number of days between the first documented ANC less than or equal to 500 and the first documented ANC greater than 500 following nadir
measure: Days delayed in beginning the next course of chemotherapy
time frame: Will be assessed weekly until the next course of chemotherapy is initiated, up to 1 year
description: A delay in chemotherapy is defined when the initiation of the next course of chemotherapy is delayed due to neutropenia
measure: Needle distress
time frame: 2 days
description: Distress Rating Tool: The DRS version for 2-, 3-, and 4-year-olds has three faces with different facial expressions for children to point to the one that best matches how they feel. The version for 5- and 6-year-olds has a visual analog scale presented as a thermometer with a happy face drawn next to the 0 and a sad face drawn next to the 10. The DRT version for youth 7 to 18 years defines distress as 'worry, anxiety, sadness, or fear,' on a scale from 0 (no distress) to 5 (moderate distress) to 10 (high distress). The adult DRS will be used for youth 19 to 21 years. Caregivers will rate their perception of their child's distress
measure: Physical Side Effects
time frame: 1 week
description: Memorial Symptom Assessment Scale: Physical and psychological symptoms; 8 items on 3-4 point scale (7-12 yrs) during past 2 days; 22 items on 4-5 point scale (10-14 yrs) during past week
arm group label: Receive G-CSF 72 hours following chemotherapy
arm group type: Experimental
description: Children will be enrolled during the first four rounds of chemotherapy. Upon enrollment, children will receive G-CSF at 24 hours following chemotherapy. G-CSF will be discontinued when absolute neutrophil count (ANC) has increased post nadir in accord with G-CSF administration guidelines. Parents and children will then complete questionnaires to determine rates of side effects and needle distress at the end of G-CSF during their next regular outpatient oncology clinic visit.
Following children's next course of chemotherapy, G-CSF will be started 72 hours after completion of chemotherapy.
arm group label: Historical Controls
arm group type: No Intervention
description: Four matched historical controls who received G-CSF at 24 hours following chemotherapy for each patient enrolled will be selected as each enrolled patient completes G-CSF therapy.
intervention type: Drug
intervention name: Granulocyte Colony-Stimulating Factor
description: Begin G-CSF 72 hours following chemotherapy
arm group label: Receive G-CSF 72 hours following chemotherapy
other name: G-CSF
criteria: 
gender: All
minimum age: N/A
maximum age: 21 Years
healthy volunteers: No
last name: Anderson B Collier, MD
role: Principal Investigator
affiliation: University of Mississippi Medical Center
last name: Anderson B Collier, MD
phone: 601-984-5221
email: acollier@umc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Neutropenia
mesh term: Febrile Neutropenia
mesh term: Chemotherapy-Induced Febrile Neutropenia
mesh term: Lenograstim
sharing ipd: No