<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/NCT03021330</url>
  </required_header>
  <id_info>
    <org_study_id>IIT2016007-EC-1-1</org_study_id>
    <nct_id>NCT03021330</nct_id>
  </id_info>
  <brief_title>Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML</brief_title>
  <official_title>Efficacy of Intermediate-Dose Cytarabine Induction Regimen in Adult AML</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, randomized, prospective clinical trial, newly-diagnosed AML patients will&#xD;
      be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen&#xD;
      with intermediate dose of cytarabine. In the control arm, patients receive DA regimen with&#xD;
      standard dose of cytarabine.The efficacy of induction therapy containing intermediate dose of&#xD;
      cytarabine is evaluated and adverse events associated with treatment are recorded.The primary&#xD;
      end point is overall survival.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will&#xD;
      be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen&#xD;
      with intermediate dose of cytarabine at at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/Q12h on&#xD;
      day5-7. In the control arm, patients receive DA regimen with standard dose of cytarabine at a&#xD;
      dose of 100mg/㎡/d on day 1-7. Patients receive consolidation therapy containing high-dose&#xD;
      cytarabine after achieved complete remission. Stem-cell transplantation is permitted for&#xD;
      patients with intermediate- or poor-risk disease. The efficacy of induction therapy&#xD;
      containing intermediate dose of cytarabine is evaluated and adverse events associated with&#xD;
      treatment are recorded.The primary end point is overall survival.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <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 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival Rate (OS)</measure>
    <time_frame>Within 5 years after randomization</time_frame>
    <description>OS is defined as the time from the date of randomization until the date of death from any cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete Remission Rate</measure>
    <time_frame>Within 2 months after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-Free Survival Rate</measure>
    <time_frame>Within 5 years after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapse-Free Survival Rate (RFS)</measure>
    <time_frame>Within 5 years after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of relapse</measure>
    <time_frame>Within 5 years after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early Mortality</measure>
    <time_frame>within 45 days after randomization</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>AML</condition>
  <arm_group>
    <arm_group_label>DA Regimen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive standard DA induction regimen including daunomycin and cytarabine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intermediate Dose of DA Regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive DA induction regimen including daunomycin and intermediate dose of cytarabine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daunomycin and Cytarabine (DA Regimen)</intervention_name>
    <description>Cytarabine at a dose of 100mg/㎡/d on day 1-7.&#xD;
Daunomycin at a dose of 60mg/㎡/d on day 1-3.</description>
    <arm_group_label>DA Regimen</arm_group_label>
    <other_name>Daunomycin and Cytarabine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)</intervention_name>
    <description>Cytarabine at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/d on day 5-7.&#xD;
Daunomycin at a dose of 60mg/㎡/d on day 1-3.</description>
    <arm_group_label>Intermediate Dose of DA Regimen</arm_group_label>
    <other_name>Daunomycin and Cytarabine</other_name>
  </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 (except APL&#xD;
             subtypes).&#xD;
&#xD;
          3. ECOG score ≤ 2;&#xD;
&#xD;
          4. Patients with eligible laboratory examination including liver,renal and heart&#xD;
             function.&#xD;
&#xD;
          5. 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. Patients who had received induction therapy.&#xD;
&#xD;
          2. Secondary leukemia.&#xD;
&#xD;
          3. 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;
          4. Patients with other blood diseases(for example, haemophiliacs) are excluded.However,&#xD;
             patients with abnormal blood count, but with undiagnosed MDS or MPD patients are&#xD;
             included.&#xD;
&#xD;
          5. Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;&#xD;
&#xD;
          6. With BCR-ABL fusion gene;&#xD;
&#xD;
          7. Pregnant or lactating women;&#xD;
&#xD;
          8. AML with ineligible renal or liver function;&#xD;
&#xD;
          9. AML with active cardiovascular disease;&#xD;
&#xD;
         10. Severe infection disease including uncured tuberculosis pulmonary aspergillosis;&#xD;
&#xD;
         11. AIDS;&#xD;
&#xD;
         12. Patients had central nervous system involvement when they were diagnosed as AML.&#xD;
&#xD;
         13. Patients with epilepsy or dementia or other mental disease who couldn't understand or&#xD;
             follow the research.&#xD;
&#xD;
         14. Drugs, medical, mental or social situation may distract patients from following the&#xD;
             research or being evaluated the results.&#xD;
&#xD;
         15. 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>
  <overall_contact>
    <last_name>Lijun Liu</last_name>
    <phone>86-22-23909237</phone>
    <email>bloodgcp@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute of Hematology &amp; Blood Diseases Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>lijun Liu</last_name>
      <phone>86-22-23909237</phone>
      <email>bloodgcp@126.com</email>
    </contact>
  </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>Cytarabine</mesh_term>
    <mesh_term>Daunorubicin</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/NCT03021330
org study id: IIT2016007-EC-1-1
nct id: NCT03021330
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will
      be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen
      with intermediate dose of cytarabine. In the control arm, patients receive DA regimen with
      standard dose of cytarabine.The efficacy of induction therapy containing intermediate dose of
      cytarabine is evaluated and adverse events associated with treatment are recorded.The primary
      end point is overall survival.
In this open-label, randomized, prospective clinical trial, newly-diagnosed AML patients will
      be randomized into 2 groups. In the experimental arm, patients receive DA induction regimen
      with intermediate dose of cytarabine at at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/Q12h on
      day5-7. In the control arm, patients receive DA regimen with standard dose of cytarabine at a
      dose of 100mg/㎡/d on day 1-7. Patients receive consolidation therapy containing high-dose
      cytarabine after achieved complete remission. Stem-cell transplantation is permitted for
      patients with intermediate- or poor-risk disease. The efficacy of induction therapy
      containing intermediate dose of cytarabine is evaluated and adverse events associated with
      treatment are recorded.The primary end point is overall survival.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival Rate (OS)
time frame: Within 5 years after randomization
description: OS is defined as the time from the date of randomization until the date of death from any cause.
measure: Complete Remission Rate
time frame: Within 2 months after randomization
measure: Event-Free Survival Rate
time frame: Within 5 years after randomization
measure: Relapse-Free Survival Rate (RFS)
time frame: Within 5 years after randomization
measure: Cumulative incidence of relapse
time frame: Within 5 years after randomization
measure: Early Mortality
time frame: within 45 days after randomization
arm group label: DA Regimen
arm group type: Active Comparator
description: Patients receive standard DA induction regimen including daunomycin and cytarabine.
arm group label: Intermediate Dose of DA Regimen
arm group type: Experimental
description: Patients receive DA induction regimen including daunomycin and intermediate dose of cytarabine.
intervention type: Drug
intervention name: Daunomycin and Cytarabine (DA Regimen)
description: Cytarabine at a dose of 100mg/㎡/d on day 1-7.
Daunomycin at a dose of 60mg/㎡/d on day 1-3.
arm group label: DA Regimen
other name: Daunomycin and Cytarabine
intervention type: Drug
intervention name: Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)
description: Cytarabine at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/d on day 5-7.
Daunomycin at a dose of 60mg/㎡/d on day 1-3.
arm group label: Intermediate Dose of DA Regimen
other name: Daunomycin and Cytarabine
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
last name: Lijun Liu
phone: 86-22-23909237
email: bloodgcp@126.com
facility: 
status: Recruiting
contact: 
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: Cytarabine
mesh term: Daunorubicin
sharing ipd: No