<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/NCT03255668</url>
  </required_header>
  <id_info>
    <org_study_id>IndonesiaFKUI</org_study_id>
    <nct_id>NCT03255668</nct_id>
  </id_info>
  <brief_title>Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia</brief_title>
  <official_title>Haematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia: Focus on Genotyping and Phenotyping of Mercaptopurine</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>
      Subjects who are recruited in this study are LLA patient, who are treated for routine control&#xD;
      to Cipto Mangunkusumo Hospital, who meet the inclusion criteria and do not meet the exclusion&#xD;
      criteria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On the day of the control patient, (usually the patient is asked for routine control at week&#xD;
      3 on mercaptopurin) routine blood tests are performed. Patients and parents were given an&#xD;
      explanation of this study. If patients and parents are willing to take part in the study,&#xD;
      they are asked to sign informed consent. Patients who meet the inclusion criteria and do not&#xD;
      meet the exclusion criteria, are recorded for demographic data and 5 ml of blood taking. The&#xD;
      blood is directly divided into three, 2 mL for hematologic examination and albumin level, 1&#xD;
      mL for genotyping, and 2 mL for examination of drug levels. Routine hematologic examination&#xD;
      and albumin levels were performed in the Cipto Mangunkusumo hospital laboratory. For&#xD;
      genotypic examination, blood samples were stored at -80C, until they were used for analysis.&#xD;
      For examination of the drug levels the blood sample is centrifuged and the erythrocyte&#xD;
      preparation is then stored at -80C, until it is used for analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 25, 2017</start_date>
  <completion_date type="Actual">November 1, 2018</completion_date>
  <primary_completion_date type="Actual">October 15, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia, the relationship the event with genotyping and phenotyping</measure>
    <time_frame>August 2017 - May 2018</time_frame>
    <description>Haematology data (hemoglobin, leukocites, platelets, absolute neutrophil count), TPMT genotyping, and blood concentration of 6-meMP and 6-TGN (=phenotyping).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>other Factors that can influence the incidence of hematotoxicity</measure>
    <time_frame>July 2017 - May 2018</time_frame>
    <description>relaps risk stratification (High risk or standard risk), nutrition status,and albumin levels</description>
  </secondary_outcome>
  <enrollment type="Actual">106</enrollment>
  <condition>Mercaptopurine Adverse Reaction</condition>
  <condition>Leukemia, Lymphoblastic</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric patients with LLA who received 6-MP chemotherapy in the maintenance phase, who&#xD;
        come to RSCM, and who meets the inclusion criteria and does not meet the exclusion&#xD;
        criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute lymphoblastic leukemia (ALL) patients, 1 until 18 years old, male or female, who&#xD;
             come to Cipto Mangunkusumo Hospital, Jakarta, Indonesia&#xD;
&#xD;
          -  Received 6MP chemotherapy at least 1 month maintenance phase&#xD;
&#xD;
          -  Received maintenance phase treatment regimen&#xD;
&#xD;
          -  Willing to participate in research, signed informed consent and obtained parental&#xD;
             consent to participate in research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients are experiencing severe infections&#xD;
&#xD;
          -  Patients receiving colony stimulating factor (CSF), allopurinol, mesalazine,&#xD;
             olsalazine, and sulfasalazine&#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>Department of Pharmacology and therapeutic, FMUI</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Djajadiman Gatot, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Pediatric</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>November 2018</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>November 19, 2018</last_update_submitted>
  <last_update_submitted_qc>November 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 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>Medical Doctor, MSc</investigator_title>
  </responsible_party>
  <keyword>Mercaptopurine, acute lymphoblastic leukemia, hematotoxicity</keyword>
  <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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 12, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03255668/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03255668
org study id: IndonesiaFKUI
nct id: NCT03255668
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Subjects who are recruited in this study are LLA patient, who are treated for routine control
      to Cipto Mangunkusumo Hospital, who meet the inclusion criteria and do not meet the exclusion
      criteria.
On the day of the control patient, (usually the patient is asked for routine control at week
      3 on mercaptopurin) routine blood tests are performed. Patients and parents were given an
      explanation of this study. If patients and parents are willing to take part in the study,
      they are asked to sign informed consent. Patients who meet the inclusion criteria and do not
      meet the exclusion criteria, are recorded for demographic data and 5 ml of blood taking. The
      blood is directly divided into three, 2 mL for hematologic examination and albumin level, 1
      mL for genotyping, and 2 mL for examination of drug levels. Routine hematologic examination
      and albumin levels were performed in the Cipto Mangunkusumo hospital laboratory. For
      genotypic examination, blood samples were stored at -80C, until they were used for analysis.
      For examination of the drug levels the blood sample is centrifuged and the erythrocyte
      preparation is then stored at -80C, until it is used for analysis.
observational model: Other
time perspective: Cross-Sectional
measure: Hematotoxicity in Maintenance Therapy of Children With Acute Lymphoblastic Leukemia, the relationship the event with genotyping and phenotyping
time frame: August 2017 - May 2018
description: Haematology data (hemoglobin, leukocites, platelets, absolute neutrophil count), TPMT genotyping, and blood concentration of 6-meMP and 6-TGN (=phenotyping).
measure: other Factors that can influence the incidence of hematotoxicity
time frame: July 2017 - May 2018
description: relaps risk stratification (High risk or standard risk), nutrition status,and albumin levels
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: Department of Pharmacology and therapeutic, FMUI
last name: Djajadiman Gatot, Professor
role: Study Chair
affiliation: Department of Pediatric
facility: 
country: Indonesia
responsible party type: Principal Investigator
investigator affiliation: Indonesia University
investigator full name: Dewi Selvina Rosdiana
investigator title: Medical Doctor, MSc
mesh term: Leukemia
mesh term: Precursor Cell Lymphoblastic Leukemia-Lymphoma
mesh term: Leukemia, Lymphoid
sharing ipd: No
provided document: 