<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/NCT03021395</url>
  </required_header>
  <id_info>
    <org_study_id>IIT2016007-EC-1-4</org_study_id>
    <nct_id>NCT03021395</nct_id>
  </id_info>
  <brief_title>Efficacy of Decitabine in Clearance of MRD</brief_title>
  <official_title>Efficacy of Decitabine in Clearance of MRD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Hematology &amp; Blood Diseases Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Hematology &amp; Blood Diseases Hospital, China</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In this open-label, prospective clinical trial, the investigators enrolled acute myeloid&#xD;
      leukemia (AML) patients after consolidation therapy. Patients with minimal residual disease&#xD;
      (MRD) receive decitabine treatment if patients do not receive stem cell transplantation. The&#xD;
      MRD clearance rate is the primary outcome to measure the efficacy of decitabine regimen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this open-label, prospective clinical trial, acute myeloid leukemia (AML) patients after&#xD;
      consolidation therapy are enrolled. Patients with minimal residual disease (MRD) after&#xD;
      consolidation therapy receive decitabine treatment if patients do not receive stem cell&#xD;
      transplantation. The treatment regimen includes three course of decitabine regimen at a dose&#xD;
      of 20mg/m² on day1-5. The MRD clearance rate is the primary outcome to measure the efficacy&#xD;
      of decitabine regimen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    The previous data needs to be analyzed.&#xD;
  </why_stopped>
  <start_date type="Actual">February 8, 2017</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>MRD Clearance Rate</measure>
    <time_frame>Within 6 months after decitabine treatment</time_frame>
    <description>MRD Clearance Rate is defined as the ratio patients that transform from MRD-positive to MRD-negative after treatment in all of the MRD-positive patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Non-relapse Mortality</measure>
    <time_frame>Within 5 years after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival Rate (OS)</measure>
    <time_frame>Within 5 years after treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of relapse</measure>
    <time_frame>Within 5 years after treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>AML</condition>
  <arm_group>
    <arm_group_label>MRD-positive</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MRD-positive patients receive Decitabine regimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MRD-negative</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>MRD-negative patients receive no intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decitabine</intervention_name>
    <description>Decitabine at a dose of 20mg/㎡/d on day 1-5.</description>
    <arm_group_label>MRD-positive</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age of 14 to 55 years old;&#xD;
&#xD;
          2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML after&#xD;
             consolidation regimen.&#xD;
&#xD;
          3. Patients who had received induction and consolation therapy and reached CR.&#xD;
&#xD;
          4. ECOG score of ≤ 2;&#xD;
&#xD;
          5. Patients with eligible laboratory examination including liver,renal and heart&#xD;
             function.&#xD;
&#xD;
          6. Adult patients are willing to participate in the study and sign the informed consent&#xD;
             by themselves or by their immediate family. Patients under 18 years old willing to&#xD;
             participate should have their legal guardians sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Secondary leukemia.&#xD;
&#xD;
          2. Patients had other tumor at active stage or had received radiotherapy or chemotherapy&#xD;
             in the last 6 months due to other tumor.&#xD;
&#xD;
          3. Patients with other blood diseases(for example, haemophiliacs) are excluded.However,&#xD;
             undiagnosed MDS or MPD patients are included.&#xD;
&#xD;
          4. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;&#xD;
&#xD;
          5. With BCR-ABL fusion gene;&#xD;
&#xD;
          6. Pregnant or lactating women;&#xD;
&#xD;
          7. With ineligible renal or liver function;&#xD;
&#xD;
          8. With active cardiovascular disease;&#xD;
&#xD;
          9. Severe infection disease including uncured tuberculosis pulmonary aspergillosis;&#xD;
&#xD;
         10. AIDS;&#xD;
&#xD;
         11. Patients had central nervous system involvement when they were diagnosed as AML.&#xD;
&#xD;
         12. Patients with epilepsy or dementia or other mental disease who couldn't understand or&#xD;
             follow the research.&#xD;
&#xD;
         13. Drugs, medical, mental or social situation may distract patients from following the&#xD;
             research or being evaluated the results.&#xD;
&#xD;
         14. Patients with other factors which were considered unsuitable to participate in the&#xD;
             study by the investigators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianxiang Wang, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Hematology &amp; Blood Diseases Hospital, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Hematology &amp; Blood Diseases Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>March 21, 2019</last_update_submitted>
  <last_update_submitted_qc>March 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institute of Hematology &amp; Blood Diseases Hospital, China</investigator_affiliation>
    <investigator_full_name>wang, jianxiang</investigator_full_name>
    <investigator_title>Director of Diagnosis and Treatment Center for Leukemia</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Decitabine</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/NCT03021395
org study id: IIT2016007-EC-1-4
nct id: NCT03021395
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this open-label, prospective clinical trial, the investigators enrolled acute myeloid
      leukemia (AML) patients after consolidation therapy. Patients with minimal residual disease
      (MRD) receive decitabine treatment if patients do not receive stem cell transplantation. The
      MRD clearance rate is the primary outcome to measure the efficacy of decitabine regimen.
In this open-label, prospective clinical trial, acute myeloid leukemia (AML) patients after
      consolidation therapy are enrolled. Patients with minimal residual disease (MRD) after
      consolidation therapy receive decitabine treatment if patients do not receive stem cell
      transplantation. The treatment regimen includes three course of decitabine regimen at a dose
      of 20mg/m² on day1-5. The MRD clearance rate is the primary outcome to measure the efficacy
      of decitabine regimen.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: MRD Clearance Rate
time frame: Within 6 months after decitabine treatment
description: MRD Clearance Rate is defined as the ratio patients that transform from MRD-positive to MRD-negative after treatment in all of the MRD-positive patients.
measure: Non-relapse Mortality
time frame: Within 5 years after treatment
measure: Overall Survival Rate (OS)
time frame: Within 5 years after treatment
measure: Cumulative incidence of relapse
time frame: Within 5 years after treatment
arm group label: MRD-positive
arm group type: Experimental
description: MRD-positive patients receive Decitabine regimen.
arm group label: MRD-negative
arm group type: No Intervention
description: MRD-negative patients receive no intervention.
intervention type: Drug
intervention name: Decitabine
description: Decitabine at a dose of 20mg/㎡/d on day 1-5.
arm group label: MRD-positive
criteria: 
gender: All
minimum age: 14 Years
maximum age: 55 Years
healthy volunteers: No
last name: Jianxiang Wang, Dr
role: Principal Investigator
affiliation: Institute of Hematology & Blood Diseases Hospital, China
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Institute of Hematology & Blood Diseases Hospital, China
investigator full name: wang, jianxiang
investigator title: Director of Diagnosis and Treatment Center for Leukemia
mesh term: Decitabine
sharing ipd: No