<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/NCT02975115</url>
  </required_header>
  <id_info>
    <org_study_id>PCR-DEPTH</org_study_id>
    <nct_id>NCT02975115</nct_id>
  </id_info>
  <brief_title>Evaluating True PCR-negative Rate of Frontline Dasatinib in Early Chronic Phase CML for Therapeutic Harmonization</brief_title>
  <official_title>The Catholic University of Korea Cancer Research Institute</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul St. Mary's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul St. Mary's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to confirm the efficacy of dasatinib 100mg once daily in producing a&#xD;
      complete molecular response and to prove a possibility of &quot;Operational Cure&quot; in CMR patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study also examines kinetics of complete molecular responses using new highly sensitive&#xD;
      PCR based technology, digital PCR, which is reported to have a sensitivity down to 6 log&#xD;
      reduction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2013</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of CMR(complete molecular response)</measure>
    <time_frame>36 month</time_frame>
    <description>Level of Bcr-Abl transcript (Conventional Q-RT-PCR)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of MMR(major molecular response)</measure>
    <time_frame>3,6,12,24 and 36 months</time_frame>
    <description>Level of Bcr-Abl transcript (Conventional Q-RT-PCR)</description>
  </secondary_outcome>
  <enrollment type="Actual">102</enrollment>
  <condition>Chronic Myelocytic Leukemia</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>RQ-PCR RNA Analysis</intervention_name>
    <description>Conventional Q-RT-PCR every 3 months</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Rest of RNA samples after Q-RT-PCR analysis&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Newly diagnosed, CP-CML patients ≥ 18 years of age. Use of dasatinib for less than three&#xD;
        weeks prior to study entry is allowed.&#xD;
&#xD;
        Adult patients with a molecularly confirmed diagnosis of BCR-ABL positive CML in new CP who&#xD;
        have not been treated with any myeloablative or interferon alpha therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have Ph+ CML in CP&#xD;
&#xD;
          -  newly diagnosed chronic phase CML, except hydroxyurea, anagrelide and within 7 days&#xD;
             imatinib treatment&#xD;
&#xD;
          -  Subjects must be enrolled in this study within approximately 3 months (90 days) after&#xD;
             the date of first being diagnosed with CML. Subjects are allowed to have clonal&#xD;
             chromosomal abnormalities in addition to the Philadelphia chromosome and remain&#xD;
             eligible&#xD;
&#xD;
          -  0-2 ECOG Performance Status (PS) Score&#xD;
&#xD;
          -  Adequate hepatic function test&#xD;
&#xD;
          -  Adequate renal function test&#xD;
&#xD;
          -  Adequate other organ functions&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) must be using an adequate method of&#xD;
             contraception to avoid pregnancy&#xD;
&#xD;
          -  WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L&#xD;
             or equivalent units of HCG) within 72 hours prior to the start of investigational&#xD;
             product.&#xD;
&#xD;
          -  Subjects agree to sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for&#xD;
             the entire study period and for at least one month (4 weeks) before and for at least 1&#xD;
             month (4 weeks) after the last dose of study medication.&#xD;
&#xD;
          -  WOCBP using a prohibited contraceptive method (Not applicable for this study).&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding.&#xD;
&#xD;
          -  Women with a positive pregnancy test at enrollment or prior to administration of study&#xD;
             medication.&#xD;
&#xD;
          -  Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable&#xD;
             method to avoid pregnancy for the entire study period and for at least one month (4&#xD;
             weeks) after completion of study medication.&#xD;
&#xD;
          -  A serious uncontrolled medical disorder or active infection that would impair the&#xD;
             ability of the subject to receive protocol therapy.&#xD;
&#xD;
          -  Known pleural effusion at baseline.&#xD;
&#xD;
          -  Uncontrolled or significant cardiovascular disease&#xD;
&#xD;
          -  History of significant bleeding disorder unrelated to CML&#xD;
&#xD;
          -  Prior chemotherapy for peripheral stem cell mobilization. (Prior collection of&#xD;
             un-mobilized peripheral blood stem cells is permitted).&#xD;
&#xD;
          -  Prior or concurrent malignancy&#xD;
&#xD;
          -  Evidence of digestive dysfunction that would prevent administration of study therapy&#xD;
             by mouth&#xD;
&#xD;
          -  Uncontrolled diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Goh HG, Lin M, Fukushima T, Saglio G, Kim D, Choi SY, Kim SH, Lee J, Lee YS, Oh SM, Kim DW. Sensitive quantitation of minimal residual disease in chronic myeloid leukemia using nanofluidic digital polymerase chain reaction assay. Leuk Lymphoma. 2011 May;52(5):896-904. doi: 10.3109/10428194.2011.555569. Epub 2011 Feb 21.</citation>
    <PMID>21338281</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul St. Mary's Hospital</investigator_affiliation>
    <investigator_full_name>Dong-Wook Kim</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</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/NCT02975115
org study id: PCR-DEPTH
nct id: NCT02975115
lead sponsor: 
collaborator: 
has dmc: Yes
This study is designed to confirm the efficacy of dasatinib 100mg once daily in producing a
      complete molecular response and to prove a possibility of "Operational Cure" in CMR patients.
This study also examines kinetics of complete molecular responses using new highly sensitive
      PCR based technology, digital PCR, which is reported to have a sensitivity down to 6 log
      reduction.
observational model: Cohort
measure: Rate of CMR(complete molecular response)
time frame: 36 month
description: Level of Bcr-Abl transcript (Conventional Q-RT-PCR)
measure: Rate of MMR(major molecular response)
time frame: 3,6,12,24 and 36 months
description: Level of Bcr-Abl transcript (Conventional Q-RT-PCR)
intervention type: Other
intervention name: RQ-PCR RNA Analysis
description: Conventional Q-RT-PCR every 3 months
Rest of RNA samples after Q-RT-PCR analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
citation: Goh HG, Lin M, Fukushima T, Saglio G, Kim D, Choi SY, Kim SH, Lee J, Lee YS, Oh SM, Kim DW. Sensitive quantitation of minimal residual disease in chronic myeloid leukemia using nanofluidic digital polymerase chain reaction assay. Leuk Lymphoma. 2011 May;52(5):896-904. doi: 10.3109/10428194.2011.555569. Epub 2011 Feb 21.
PMID: 21338281
responsible party type: Principal Investigator
investigator affiliation: Seoul St. Mary's Hospital
investigator full name: Dong-Wook Kim
investigator title: Director
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myelogenous, Chronic, BCR-ABL Positive
sharing ipd: No