<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/NCT03026842</url>
  </required_header>
  <id_info>
    <org_study_id>NECOG</org_study_id>
    <nct_id>NCT03026842</nct_id>
  </id_info>
  <brief_title>Decitabine Versus Conventional Chemotherapy for Maintenance Therapy of Acute Myeloid Leukemia With t(8;21)</brief_title>
  <official_title>A Prospective, Randomized, Controlled Trial of Decitabine Versus Conventional Chemotherapy for Maintenance Therapy of Patients With Acute Myeloid Leukemia With t(8;21)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Second Affiliated Hospital of Dalian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The First Hospital of Jilin University</source>
  <brief_summary>
    <textblock>
      Acute myeloid leukemia (AML) is the most common hematological malignancies in adult patients&#xD;
      with leukemia, and t(8;21) AML accounts for a substantial proportion of AML. AML patients&#xD;
      with t(8;21) possess a favorable outcome and 3 - 4 course high dose cytarabine (3 g/m2) is&#xD;
      the standard consolidation therapy for these patients with a 5-year overall survival&#xD;
      approximately 60%. In China, intermediate dose cytarabine (1 - 2 g/m2) is used for&#xD;
      consolidation therapy due to toxicities. After 3 - 4 course cytarabine consolidation,&#xD;
      maintenance therapy is performed with conventional chemotherapy with a 5-year overall&#xD;
      survival approximately 60% as well. However, continuous chemotherapy may cause toxicities and&#xD;
      inhibit patients' immune response. Exploring new drug for maintenance therapy is urgently&#xD;
      needed. Decitabine has a potent ability to inhibit proliferation and induce apoptosis of&#xD;
      AML1-ETO positive leukemia cell line. Furthermore, the immunomodulatory effect of decitabine&#xD;
      was also reported by several studies. In this study, the investigators plan to carry out a&#xD;
      prospective, multicenter, randomized, controlled trail to compare decitabine versus&#xD;
      conventional chemotherapy for maintenance therapy of patients with AML with t(8;21). Results&#xD;
      of this trial may optimize the treatment for AML patients with t(8;21) in the setting of&#xD;
      intermediate dose cytarabine consolidation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">October 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relapse free survival</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>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>From enrolling to two months after administrating the last course of decitabine or chemotherapy</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <arm_group>
    <arm_group_label>Decitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Six cycles of decitabine IV over one hour at 20 mg/m2/day for 5 days, every 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Four cycles of conventional chemotherapy for 5 days, every 12 weeks. conventional chemotherapy includes in: DA regimen: Daunorubicin 45 mg/m2/day for 3 days, cytarabine 100 mg/m2/day for 5 days; MA regimen: Mitoxantrone 8 mg/m2/day for 3 days, cytarabine 100 mg/m2/day for 5 days; AA regimen: Aclacinomycin 20 mg/day for 5 days, cytarabine 100 mg/m2/day for 5 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decitabine</intervention_name>
    <description>20 mg/m2/day for 5 days</description>
    <arm_group_label>Decitabine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daunorubicin, Cytarabine</intervention_name>
    <description>Daunorubicin: 45 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days</description>
    <arm_group_label>Conventional chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mitoxantrone, Cytarabine</intervention_name>
    <description>Mitoxantrone: 8 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days</description>
    <arm_group_label>Conventional chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aclacinomycin, Cytarabine</intervention_name>
    <description>Aclacinomycin: 20 mg/day for 5 days; Cytarabine: 100 mg/m2/day for 5 days</description>
    <arm_group_label>Conventional chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients are adults age ≥18 and ≤60 years&#xD;
&#xD;
          2. Patients are diagnosed as AML with t(8;21)&#xD;
&#xD;
          3. Continuous complete remission after induction and consolidation therapy with 3 - 4&#xD;
             course high dose cytarabine (2 g/m^2)&#xD;
&#xD;
          4. Patients whose aspartate transaminase (AST)/alanine transaminase (ALT) are ≤ 2.5 times&#xD;
             higher than the normal upper limit, total bilirubin ≤ 3.0 mg/dl, and serum creatinine&#xD;
             ≤ 2.0 mg/dl.&#xD;
&#xD;
          5. Subjects that signed the informed consent, which indicated they understood the&#xD;
             purpose, the procedure and potential benefits of the trial and were willing to&#xD;
             participate in the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or lactating women.&#xD;
&#xD;
          2. ECOG performance status score &gt; 2.&#xD;
&#xD;
          3. Patients are candidates for hematopoietic stem cell transplantation.&#xD;
&#xD;
          4. Patients with a history of use of azacitidine or decitabine.&#xD;
&#xD;
          5. Patients with mental or other disorders that cannot completely cooperate with the&#xD;
             treatment or follow up.&#xD;
&#xD;
          6. Subjects that were allergic to decitabine vehicle.&#xD;
&#xD;
          7. Patients receive immunotherapy.&#xD;
&#xD;
          8. Patients also have other organ malignant tumor.&#xD;
&#xD;
          9. Participating in other clinical research in the same period.&#xD;
&#xD;
         10. The researchers estimate that patients cannot enter the clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Su J Gao, PhD</last_name>
    <role>Study Director</role>
    <affiliation>The First Hospital of Jilin University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 15, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Hospital of Jilin University</investigator_affiliation>
    <investigator_full_name>SuJun Gao</investigator_full_name>
    <investigator_title>Head of Hematology Department</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>
    <mesh_term>Daunorubicin</mesh_term>
    <mesh_term>Mitoxantrone</mesh_term>
    <mesh_term>Aclacinomycins</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/NCT03026842
org study id: NECOG
nct id: NCT03026842
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
Acute myeloid leukemia (AML) is the most common hematological malignancies in adult patients
      with leukemia, and t(8;21) AML accounts for a substantial proportion of AML. AML patients
      with t(8;21) possess a favorable outcome and 3 - 4 course high dose cytarabine (3 g/m2) is
      the standard consolidation therapy for these patients with a 5-year overall survival
      approximately 60%. In China, intermediate dose cytarabine (1 - 2 g/m2) is used for
      consolidation therapy due to toxicities. After 3 - 4 course cytarabine consolidation,
      maintenance therapy is performed with conventional chemotherapy with a 5-year overall
      survival approximately 60% as well. However, continuous chemotherapy may cause toxicities and
      inhibit patients' immune response. Exploring new drug for maintenance therapy is urgently
      needed. Decitabine has a potent ability to inhibit proliferation and induce apoptosis of
      AML1-ETO positive leukemia cell line. Furthermore, the immunomodulatory effect of decitabine
      was also reported by several studies. In this study, the investigators plan to carry out a
      prospective, multicenter, randomized, controlled trail to compare decitabine versus
      conventional chemotherapy for maintenance therapy of patients with AML with t(8;21). Results
      of this trial may optimize the treatment for AML patients with t(8;21) in the setting of
      intermediate dose cytarabine consolidation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Relapse free survival
time frame: Three years
measure: Overall survival
time frame: Three years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: From enrolling to two months after administrating the last course of decitabine or chemotherapy
arm group label: Decitabine
arm group type: Experimental
description: Six cycles of decitabine IV over one hour at 20 mg/m2/day for 5 days, every 6 weeks
arm group label: Conventional chemotherapy
arm group type: Active Comparator
description: Four cycles of conventional chemotherapy for 5 days, every 12 weeks. conventional chemotherapy includes in: DA regimen: Daunorubicin 45 mg/m2/day for 3 days, cytarabine 100 mg/m2/day for 5 days; MA regimen: Mitoxantrone 8 mg/m2/day for 3 days, cytarabine 100 mg/m2/day for 5 days; AA regimen: Aclacinomycin 20 mg/day for 5 days, cytarabine 100 mg/m2/day for 5 days.
intervention type: Drug
intervention name: Decitabine
description: 20 mg/m2/day for 5 days
arm group label: Decitabine
intervention type: Drug
intervention name: Daunorubicin, Cytarabine
description: Daunorubicin: 45 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days
arm group label: Conventional chemotherapy
intervention type: Drug
intervention name: Mitoxantrone, Cytarabine
description: Mitoxantrone: 8 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days
arm group label: Conventional chemotherapy
intervention type: Drug
intervention name: Aclacinomycin, Cytarabine
description: Aclacinomycin: 20 mg/day for 5 days; Cytarabine: 100 mg/m2/day for 5 days
arm group label: Conventional chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Su J Gao, PhD
role: Study Director
affiliation: The First Hospital of Jilin University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Hospital of Jilin University
investigator full name: SuJun Gao
investigator title: Head of Hematology Department
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Cytarabine
mesh term: Decitabine
mesh term: Daunorubicin
mesh term: Mitoxantrone
mesh term: Aclacinomycins
sharing ipd: No