<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/NCT03279900</url>
  </required_header>
  <id_info>
    <org_study_id>IndonesiaUI</org_study_id>
    <nct_id>NCT03279900</nct_id>
  </id_info>
  <brief_title>Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy</brief_title>
  <official_title>Hematotoxicity in Acute Lymphoblastic Leukemia Children in Maintenance Phase Therapy at Cipto Mangunkusumo Hospital and Its Affecting Factors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indonesia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indonesia University</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>
      This study use an observational study design from patient medical records to obtain data on&#xD;
      patient demographics, nutritional status, 6MP dosing, and albumin levels of LLA child&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All medical record data of LLA child patient at maintenance phase therapy, who came to Cipto&#xD;
      Mangunkusumo Kiara Hospital in period 2014 - 2016. the data that are colected consist of age,&#xD;
      gender, disease stratification, nutritional status, the dosage of 6-MP, albumin levels,&#xD;
      hemoglobin levels, leukocyite counts, platelet counts, and absolute neutrophil counts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">July 16, 2018</completion_date>
  <primary_completion_date type="Actual">May 16, 2018</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The Incidence of hematotoxicity in acute limphoblastic leukemia children during maintenance phase therapy.</measure>
    <time_frame>october 2017</time_frame>
    <description>based on medical record data: Incidence of anemia, Neutropenia, and thrombocytopenia in acute limphoblastic leukemia children during maintenance phase therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The relationship of the incidence of hematotoxicity with influencing factors</measure>
    <time_frame>November 2017</time_frame>
    <description>The relationship of the incidence of hematotoxicity (anemia, Neutropenia, thrombocitopenia) with ALL stratification (High risk or Standard risk, as written in the medical record), nutritional status (normal or malnutrition), and albumin levels (normal or Hypoalbuminemia). The determination of nutritional status is based on body weight (Kg) and Height (Meters). Determination of nutritional status using cutoff Z score based on The growth chart of WHO 2006 for children 0-5 years, and ideal weight percentage according to Waterlow criteria for children above 5 years (recommendation of Indonesian Pediatric Association).</description>
  </secondary_outcome>
  <enrollment type="Actual">101</enrollment>
  <condition>Acute Leukemia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Medical record of Acute Limphoblastic Leukemia patients at Cipto Mangunkusumo Hospital, in&#xD;
        period of 2012 - 2014&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Medical record of Acute Limphoblastic Leukemia patients at Cipto Mangunkusumo Hospital, in&#xD;
        period of 2012 - 2014, with Inclusion Criteria:&#xD;
&#xD;
          -  LLA Patients, male and female, age 1 - &lt;18 years&#xD;
&#xD;
          -  Received chemotherapy maintenance phase based on Indonesian protocol of ALL - 2013&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Incomplete medical record data.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rianto Setiabudy, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Departemen of Pharmacology and therapeutics, FMUI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cipto Mangunkusomo hospital</name>
      <address>
        <city>Jakarta Pusat</city>
        <state>Jakarta</state>
        <zip>10430</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 17, 2018</last_update_submitted>
  <last_update_submitted_qc>September 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indonesia University</investigator_affiliation>
    <investigator_full_name>Dewi Selvina Rosdiana</investigator_full_name>
    <investigator_title>Researcher at Department of Pharmacology and Therapeutics Faculty of Medicine University of Indonesia</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
  </condition_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/NCT03279900
org study id: IndonesiaUI
nct id: NCT03279900
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study use an observational study design from patient medical records to obtain data on
      patient demographics, nutritional status, 6MP dosing, and albumin levels of LLA child
      patients.
All medical record data of LLA child patient at maintenance phase therapy, who came to Cipto
      Mangunkusumo Kiara Hospital in period 2014 - 2016. the data that are colected consist of age,
      gender, disease stratification, nutritional status, the dosage of 6-MP, albumin levels,
      hemoglobin levels, leukocyite counts, platelet counts, and absolute neutrophil counts.
observational model: Cohort
time perspective: Cross-Sectional
measure: The Incidence of hematotoxicity in acute limphoblastic leukemia children during maintenance phase therapy.
time frame: october 2017
description: based on medical record data: Incidence of anemia, Neutropenia, and thrombocytopenia in acute limphoblastic leukemia children during maintenance phase therapy.
measure: The relationship of the incidence of hematotoxicity with influencing factors
time frame: November 2017
description: The relationship of the incidence of hematotoxicity (anemia, Neutropenia, thrombocitopenia) with ALL stratification (High risk or Standard risk, as written in the medical record), nutritional status (normal or malnutrition), and albumin levels (normal or Hypoalbuminemia). The determination of nutritional status is based on body weight (Kg) and Height (Meters). Determination of nutritional status using cutoff Z score based on The growth chart of WHO 2006 for children 0-5 years, and ideal weight percentage according to Waterlow criteria for children above 5 years (recommendation of Indonesian Pediatric Association).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: Rianto Setiabudy, Professor
role: Study Director
affiliation: Departemen of Pharmacology and therapeutics, FMUI
facility: 
country: Indonesia
responsible party type: Principal Investigator
investigator affiliation: Indonesia University
investigator full name: Dewi Selvina Rosdiana
investigator title: Researcher at Department of Pharmacology and Therapeutics Faculty of Medicine University of Indonesia
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
sharing ipd: No