<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/NCT02985372</url>
  </required_header>
  <id_info>
    <org_study_id>ESDCLDC in NDEAML</org_study_id>
    <nct_id>NCT02985372</nct_id>
  </id_info>
  <brief_title>Decitabine in Combination With Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia</brief_title>
  <official_title>Efficacy and Safety of Decitabine in Combination With Low-dose Cytarabine as Inductive Treatment in Newly Diagnosed Elderly Patients With Acute Myeloid Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chunyan Ji</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Binzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shengli Oilfield Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Heze Municipal Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jinan Military Genaral Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jinan Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jining Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Linyi People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qingdao University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rizhao People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qianfoshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qilu Hospital of Shandong University (Qingdao)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taian City Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taishan Medical University Affiliated Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Weihai Municipal Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Weifang Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zibo First Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Central Hospital of Zibo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shandong University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective multicenter clinical study was designed to assess the efficacy and safety of&#xD;
      decitabine in combination with low-dose cytarabine induction treatment for elderly patients&#xD;
      with newly diagnosed acute myeloid leukemia (AML).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5&#xD;
      consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days&#xD;
      (day 4-13).&#xD;
&#xD;
      Hydroxyurea was permitted as rescue medication if white blood count (WBC) was &gt;20×109/L and&#xD;
      but was discontinued at least 24h before decitabine treatment.&#xD;
&#xD;
      Supportive care including blood product transfusions, G-CSF, antiemetic medications,&#xD;
      antiviral and antifungal medications, or empiric antibiotics may be used at the clinical&#xD;
      discretion of the investigator.&#xD;
&#xD;
      Curative effect was evaluated after two cycles:&#xD;
&#xD;
        1. &lt;5% blast in the marrow, enter into maintenance therapy (Group A)&#xD;
&#xD;
        2. ≥5% blast in the marrow, continue induction therapy two cycles,&#xD;
&#xD;
           ① &lt;5% blast in the marrow, enter into maintenance therapy (Group B);&#xD;
&#xD;
           ② ≥5% blast in the marrow, dropped out of the study (Group C)&#xD;
&#xD;
        3. marrow blast decline &lt;60%, dropped out of the study (Group C).&#xD;
&#xD;
      Maintenance therapy regimen:&#xD;
&#xD;
        1. Ara-C 1g/m2/d iv drip d1-4 1 cycle&#xD;
&#xD;
        2. DEC 15mg/m2/d iv drip d1-5 1 cycle&#xD;
&#xD;
        3. Ara-C 1g/m2/d iv drip d1-4 1 cycle&#xD;
&#xD;
        4. DEC 15mg/m2/d iv drip d1-5 1 cycle&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall response rate</measure>
    <time_frame>three years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>complete remission rate</measure>
    <time_frame>three years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>three years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>three years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality rate</measure>
    <time_frame>three years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recurrence rate</measure>
    <time_frame>three years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Acute Myeloid Leukemia, Adult</condition>
  <arm_group>
    <arm_group_label>Acute myeloid leukemia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decitabine</intervention_name>
    <description>All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).</description>
    <arm_group_label>Acute myeloid leukemia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cytarabine</intervention_name>
    <arm_group_label>Acute myeloid leukemia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with previously untreated non-M3 AML (diagnosed by the WHO2016 criteria).&#xD;
&#xD;
          2. Age: ≥ 60 and ≤ 75 years.&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.&#xD;
&#xD;
          4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5x upper limit&#xD;
             of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine &lt; 2ULN.&#xD;
&#xD;
          5. Without central nervous system symptoms.&#xD;
&#xD;
          6. Willing to accept the follow-up.&#xD;
&#xD;
          7. Normal heart function(EF&gt;50%). The subjects volunteer to sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. With severe cardiac, renal or hepatic insufficiency.&#xD;
&#xD;
          2. With other cancers requiring treatment.&#xD;
&#xD;
          3. With other hematological diseases(e.g. Hemophilia, myelofibrosis, etc.).&#xD;
&#xD;
          4. With severe infection or metabolic disease(including tuberculosis and pulmonary&#xD;
             aspergillosis).&#xD;
&#xD;
          5. Brain disorders or severe mental diseases which could limit compliance with study&#xD;
             requirements.&#xD;
&#xD;
          6. Major operation within 3 weeks.&#xD;
&#xD;
          7. With HIV infection or AIDS-associated diseases.&#xD;
&#xD;
          8. Any drug abuse, medical, mental or social situations which would affect the results.&#xD;
&#xD;
          9. Hypersensitivity to cytarabine (not including drug fever or exanthema) or decitabine.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chunyan Ji, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Shandong University</affiliation>
  </overall_official>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 3, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 3, 2016</last_update_submitted>
  <last_update_submitted_qc>December 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Chunyan Ji</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Myeloid</mesh_term>
    <mesh_term>Leukemia, Myeloid, Acute</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cytarabine</mesh_term>
    <mesh_term>Decitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02985372
org study id: ESDCLDC in NDEAML
nct id: NCT02985372
lead sponsor: 
collaborator: 
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has dmc: No
This prospective multicenter clinical study was designed to assess the efficacy and safety of
      decitabine in combination with low-dose cytarabine induction treatment for elderly patients
      with newly diagnosed acute myeloid leukemia (AML).
All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5
      consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days
      (day 4-13).

      Hydroxyurea was permitted as rescue medication if white blood count (WBC) was >20×109/L and
      but was discontinued at least 24h before decitabine treatment.

      Supportive care including blood product transfusions, G-CSF, antiemetic medications,
      antiviral and antifungal medications, or empiric antibiotics may be used at the clinical
      discretion of the investigator.

      Curative effect was evaluated after two cycles:

        1. <5% blast in the marrow, enter into maintenance therapy (Group A)

        2. ≥5% blast in the marrow, continue induction therapy two cycles,

           ① <5% blast in the marrow, enter into maintenance therapy (Group B);

           ② ≥5% blast in the marrow, dropped out of the study (Group C)

        3. marrow blast decline <60%, dropped out of the study (Group C).

      Maintenance therapy regimen:

        1. Ara-C 1g/m2/d iv drip d1-4 1 cycle

        2. DEC 15mg/m2/d iv drip d1-5 1 cycle

        3. Ara-C 1g/m2/d iv drip d1-4 1 cycle

        4. DEC 15mg/m2/d iv drip d1-5 1 cycle
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall response rate
time frame: three years
measure: complete remission rate
time frame: three years
measure: Overall survival
time frame: three years
measure: progression-free survival
time frame: three years
measure: mortality rate
time frame: three years
measure: recurrence rate
time frame: three years
arm group label: Acute myeloid leukemia
arm group type: Experimental
description: All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).
intervention type: Drug
intervention name: Decitabine
description: All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).
arm group label: Acute myeloid leukemia
intervention type: Drug
intervention name: Cytarabine
arm group label: Acute myeloid leukemia
criteria: 
gender: All
minimum age: 60 Years
maximum age: 75 Years
healthy volunteers: No
last name: Chunyan Ji, Doctor
role: Study Chair
affiliation: Shandong University
responsible party type: Sponsor-Investigator
investigator affiliation: Shandong University
investigator full name: Chunyan Ji
investigator title: professor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Cytarabine
mesh term: Decitabine
sharing ipd: Undecided