<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/NCT04415008</url>
  </required_header>
  <id_info>
    <org_study_id>IHBD-IIT2020008</org_study_id>
    <nct_id>NCT04415008</nct_id>
  </id_info>
  <brief_title>Efficacy of HAD Induction With Intensified Cytarabine in Newly-diagnosed CEBPA Double Mutated Acute Myeloid Leukemia</brief_title>
  <official_title>A Prospective, Multicenter, Single Arm Clinical Study to Evaluate Efficacy of HAD Induction With Intensified Cytarabine in Newly-diagnosed CEBPA Double Mutated Acute Myeloid Leukemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>wang, jianxiang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Hematology &amp; Blood Diseases Hospital, China</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>
      Acute myeloid leukemia is a heterogenous hematological malignancy, characterized by different&#xD;
      cytogenetic or molecular features. CEBPA double mutation acute myeloid leukemia （CEBPAdm&#xD;
      AML）has favourite prognosis, especially in younger adult patients. But cumulative incidence&#xD;
      of relapse of this group patients is still high, so the treatment options need to be&#xD;
      optimized urgently.HAD(homoharringtonine(HHT)+cytarabine+daunorubicin) with intermediate dose&#xD;
      cytarabine improved the survival of AML, especially in patients with CEBPA double mutation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this phase 2 study, 50 patients will be enrolled and treated with HAD induction regimen.&#xD;
      High dose cytarabine will be given after complete remission achieved. The primary endpoint&#xD;
      was relapse-free survival. Genetic mutations and measurable residual disease (MRD) will be&#xD;
      detected at diagnosis and after chemotherapy. The risk stratification according to genetic&#xD;
      mutations and MRD will also be explored.&#xD;
&#xD;
      induction chemotherapy:HHT 2mg/m2/d,day 1-7 cytarabine 100mg/m2/d, day1-4；1g/m2 /q12h ，day5-7&#xD;
      DNR 40mg/m2/d，day 1-3 re-induction chemotherapy:IDA 10mg/m2，day 1-3 cytarabine 100mg/m2，day&#xD;
      1-7 CTX 350mg/m2，day 2，day 5 consolidation chemotherapy: high dose cytarabine&#xD;
      3g/m2/Q12h,day1-3,for three cycles&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2022</primary_completion_date>
  <phase>Phase 2</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>relapse free survival</measure>
    <time_frame>5 years</time_frame>
    <description>survival from complete remission to relapse</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>complete remission rate</measure>
    <time_frame>2.5 years</time_frame>
    <description>incidence of complete remission after induction chemotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>early mortality</measure>
    <time_frame>2.5 years</time_frame>
    <description>death during 30 days from induction chemotherapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>5 years</time_frame>
    <description>duration from enrollment to death or loss of followup</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RFS cencored at stem cell transplantation</measure>
    <time_frame>5 years</time_frame>
    <description>RFS cencored at the date of stem cell transplantation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>CEBPA Double Mutation</condition>
  <condition>Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>treatment arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>prospective, open-label, multicenter,single arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HAD induction with intermediate dose cytarabine</intervention_name>
    <description>daunorubicin,cytarabine,homoharringtonine</description>
    <arm_group_label>treatment arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  newly-diagnosed of acute myeloid leukemia except acute promyelocytic leukemia&#xD;
&#xD;
          -  with CEBPA double mutation&#xD;
&#xD;
          -  age≥ 14 years and&lt;55 years，male or female&#xD;
&#xD;
          -  ECOG-PS score 0-2&#xD;
&#xD;
          -  laboratory tests（within 7 days before chemotherapy）&#xD;
&#xD;
               1. serum total bilirubin≤1.5xULN；&#xD;
&#xD;
               2. serum AST and ALT≤2.5xULN&#xD;
&#xD;
               3. serum creatinine≤2xULN；&#xD;
&#xD;
               4. cardiac enzymes≤2xULN&#xD;
&#xD;
               5. ejection fraction &gt;50% by ECHO。&#xD;
&#xD;
          -  written informed consent。&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  subject has received remission induction chemotherapy&#xD;
&#xD;
          -  secondary AML&#xD;
&#xD;
          -  with other hematological malignancy&#xD;
&#xD;
          -  with other tumors(needing treatment)&#xD;
&#xD;
          -  pregnant or lactating women&#xD;
&#xD;
          -  active heart diseases&#xD;
&#xD;
          -  severe active infection&#xD;
&#xD;
          -  unfit for enrollment evaluated by investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>HBDH</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hui Wei</last_name>
      <phone>86-22-23909020</phone>
      <email>weihui@ihcams.ac.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 5, 2021</last_update_submitted>
  <last_update_submitted_qc>August 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-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 leukemia center</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>
  </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/NCT04415008
org study id: IHBD-IIT2020008
nct id: NCT04415008
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Acute myeloid leukemia is a heterogenous hematological malignancy, characterized by different
      cytogenetic or molecular features. CEBPA double mutation acute myeloid leukemia （CEBPAdm
      AML）has favourite prognosis, especially in younger adult patients. But cumulative incidence
      of relapse of this group patients is still high, so the treatment options need to be
      optimized urgently.HAD(homoharringtonine(HHT)+cytarabine+daunorubicin) with intermediate dose
      cytarabine improved the survival of AML, especially in patients with CEBPA double mutation.
In this phase 2 study, 50 patients will be enrolled and treated with HAD induction regimen.
      High dose cytarabine will be given after complete remission achieved. The primary endpoint
      was relapse-free survival. Genetic mutations and measurable residual disease (MRD) will be
      detected at diagnosis and after chemotherapy. The risk stratification according to genetic
      mutations and MRD will also be explored.

      induction chemotherapy:HHT 2mg/m2/d,day 1-7 cytarabine 100mg/m2/d, day1-4；1g/m2 /q12h ，day5-7
      DNR 40mg/m2/d，day 1-3 re-induction chemotherapy:IDA 10mg/m2，day 1-3 cytarabine 100mg/m2，day
      1-7 CTX 350mg/m2，day 2，day 5 consolidation chemotherapy: high dose cytarabine
      3g/m2/Q12h,day1-3,for three cycles
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: relapse free survival
time frame: 5 years
description: survival from complete remission to relapse
measure: complete remission rate
time frame: 2.5 years
description: incidence of complete remission after induction chemotherapy
measure: early mortality
time frame: 2.5 years
description: death during 30 days from induction chemotherapy
measure: overall survival
time frame: 5 years
description: duration from enrollment to death or loss of followup
measure: RFS cencored at stem cell transplantation
time frame: 5 years
description: RFS cencored at the date of stem cell transplantation
arm group label: treatment arm
arm group type: Experimental
description: prospective, open-label, multicenter,single arm
intervention type: Drug
intervention name: HAD induction with intermediate dose cytarabine
description: daunorubicin,cytarabine,homoharringtonine
arm group label: treatment arm
criteria: 
gender: All
minimum age: 14 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Institute of Hematology & Blood Diseases Hospital, China
investigator full name: wang, jianxiang
investigator title: Director of leukemia center
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Cytarabine
sharing ipd: No