<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/NCT03256071</url>
  </required_header>
  <id_info>
    <org_study_id>DAC+BUCY</org_study_id>
    <nct_id>NCT03256071</nct_id>
  </id_info>
  <brief_title>Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT</brief_title>
  <official_title>Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Soochow University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jiangsu University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Xuzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Southeast University, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The First Affiliated Hospital of Soochow University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this prospective, open-label, randomized multicenter study is to evaluate the&#xD;
      safety and efficacy of low dose decitabine in combination with modified BUCY vs modified BUCY&#xD;
      as a myeloablative conditioning regimen for high-risk patients with acute myeloid leukemia&#xD;
      (AML) undergoing allogeneic hematopoietic stem cell transplantation (Allo-HSCT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Allo-HSCT is the most effective treatment stratagey for high risk acute myeloid leukemia. At&#xD;
      present, modified BUCY is the standard conditioning regimen for AML undergoing allo-HSCT in&#xD;
      our institute. However, relapse occured in as high as 30-50% high risk AML patients after&#xD;
      allo-HSCT. Thus, the best conditioning regimen for this subgroup remains to be optimized. Low&#xD;
      dose decitabine in combination with chemotherapy have been shown to improve comple remission&#xD;
      rate of high risk AML patients. To reduce the relapse rate after allo-HSCT, low dose&#xD;
      decitabine is added in the modified BUCY regimen. In this study, the safety and efficacy of&#xD;
      low dose decitabine + modified BUCY vs modified BUCY myeloablative conditioning regimens in&#xD;
      high risk undergoing allo-HSCT are evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <phase>Phase 2/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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>disease-free survival (DFS)</measure>
    <time_frame>3 year</time_frame>
    <description>time from randomization to the first of reccurrence or death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>overall survival (OS)</measure>
    <time_frame>3 year</time_frame>
    <description>time from randomization to death from any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>veno-occlusive disease (VOD)</measure>
    <time_frame>3 year</time_frame>
    <description>incidence of veno-occlusive disease (VOD) events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>graft-versus-host disease (GvHD)</measure>
    <time_frame>3 year</time_frame>
    <description>incidence and severity of acute (aGvHD) and chronic graft-versus-host disease (cGvHD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>transplant related mortality （TRM）</measure>
    <time_frame>3 year</time_frame>
    <description>cumulative incidence of transplant related mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>relapse</measure>
    <time_frame>3 year</time_frame>
    <description>cumulative incidence of relapse</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Acute Myeloid Leukemia</condition>
  <condition>Allogeneic Hematopoietic Stem Cell Transplantation</condition>
  <condition>Conditioning</condition>
  <arm_group>
    <arm_group_label>Decitabine plus Modified BUCY</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For high-risk patients with Acute Myeloid Leukemia (AML) undergoing allo-HSCT, The Decitabine plus Modified BuCy regimen consisted of decitabine,semustine,cytarabine, busulfan and cyclophosphamide.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Modified BUCY</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For high-risk patients with Acute Myeloid Leukemia (AML) undergoing allo-HSCT, The Modified BuCy regimen consisted of semustine,cytarabine, busulfan and cyclophosphamide.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Decitabine plus Modified BUCY</intervention_name>
    <description>Decitabine:20 mg/m²/day on day -14 to -10;&#xD;
Modified BUCY:&#xD;
Sibling:semustine 250 mg/m²/day on day -9;cytarabine 2 g/m²/day on day -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.&#xD;
Unrelated:semustine 250 mg/m²/day on day -10;cytarabine 2 g/m²/day on day -9 to -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.&#xD;
Haploidentical:semustine 250 mg/m²/day on day -10;cytarabine 4 g/m²/day on day -9 to -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.</description>
    <arm_group_label>Decitabine plus Modified BUCY</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Modified BUCY</intervention_name>
    <description>Sibling:semustine 250 mg/m²/day on day -9;cytarabine 2 g/m²/day on day -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.&#xD;
Unrelated:semustine 250 mg/m²/day on day -10;cytarabine 2 g/m²/day on day -9 to -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.&#xD;
Haploidentical:semustine 250 mg/m²/day on day -10;cytarabine 4 g/m²/day on day -9 to -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.</description>
    <arm_group_label>Modified BUCY</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 12 to 60 years.&#xD;
&#xD;
          -  Diagnosis of high-risk acute myeloid leukemia at the time of transplant. (&quot;High-risk&quot;&#xD;
             AML features are defined by the following: relapsed or primary refractory AML;&#xD;
             Secondary AML（AML Secondary to myelodysplastic syndrome(MDS) or treatment-related&#xD;
             AML); extramedullary leukemia; adverse cytogenetic abnormalities of monosomy 5,&#xD;
             monosomy 7, or deletion of 5q; or presence of FLT3 positive internal tandem&#xD;
             duplication (FLT3/ITD+), particularly high allelic ratio.)&#xD;
&#xD;
          -  Patient must have adequate pre-transplant organ function.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;12 or &gt;60 years.&#xD;
&#xD;
          -  Uncontrolled bacterial, viral, fungal, or other infection before conditioning regimen.&#xD;
&#xD;
          -  Any other severe concurrent diseases, or have a history of serious organ dysfunction.&#xD;
&#xD;
          -  Pregnant or lactating females.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Depei Wu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Soochow University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaowen Tang, MD</last_name>
    <phone>+86-512-67781851</phone>
    <email>xwtang1020@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Depei Wu, MD</last_name>
    <phone>+86-512-67781851</phone>
    <email>wudepei@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaowen Tang, MD</last_name>
      <phone>+86-512-67781851</phone>
      <email>xwtang1020@163.com</email>
    </contact>
    <investigator>
      <last_name>Depei Wu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>May 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>August 18, 2017</last_update_submitted>
  <last_update_submitted_qc>August 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Decitabine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03256071
org study id: DAC+BUCY
nct id: NCT03256071
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this prospective, open-label, randomized multicenter study is to evaluate the
      safety and efficacy of low dose decitabine in combination with modified BUCY vs modified BUCY
      as a myeloablative conditioning regimen for high-risk patients with acute myeloid leukemia
      (AML) undergoing allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
Allo-HSCT is the most effective treatment stratagey for high risk acute myeloid leukemia. At
      present, modified BUCY is the standard conditioning regimen for AML undergoing allo-HSCT in
      our institute. However, relapse occured in as high as 30-50% high risk AML patients after
      allo-HSCT. Thus, the best conditioning regimen for this subgroup remains to be optimized. Low
      dose decitabine in combination with chemotherapy have been shown to improve comple remission
      rate of high risk AML patients. To reduce the relapse rate after allo-HSCT, low dose
      decitabine is added in the modified BUCY regimen. In this study, the safety and efficacy of
      low dose decitabine + modified BUCY vs modified BUCY myeloablative conditioning regimens in
      high risk undergoing allo-HSCT are evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: disease-free survival (DFS)
time frame: 3 year
description: time from randomization to the first of reccurrence or death
measure: overall survival (OS)
time frame: 3 year
description: time from randomization to death from any cause
measure: veno-occlusive disease (VOD)
time frame: 3 year
description: incidence of veno-occlusive disease (VOD) events
measure: graft-versus-host disease (GvHD)
time frame: 3 year
description: incidence and severity of acute (aGvHD) and chronic graft-versus-host disease (cGvHD)
measure: transplant related mortality （TRM）
time frame: 3 year
description: cumulative incidence of transplant related mortality
measure: relapse
time frame: 3 year
description: cumulative incidence of relapse
arm group label: Decitabine plus Modified BUCY
arm group type: Experimental
description: For high-risk patients with Acute Myeloid Leukemia (AML) undergoing allo-HSCT, The Decitabine plus Modified BuCy regimen consisted of decitabine,semustine,cytarabine, busulfan and cyclophosphamide.
arm group label: Modified BUCY
arm group type: Active Comparator
description: For high-risk patients with Acute Myeloid Leukemia (AML) undergoing allo-HSCT, The Modified BuCy regimen consisted of semustine,cytarabine, busulfan and cyclophosphamide.
intervention type: Drug
intervention name: Decitabine plus Modified BUCY
description: Decitabine:20 mg/m²/day on day -14 to -10;
Modified BUCY:
Sibling:semustine 250 mg/m²/day on day -9;cytarabine 2 g/m²/day on day -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.
Unrelated:semustine 250 mg/m²/day on day -10;cytarabine 2 g/m²/day on day -9 to -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.
Haploidentical:semustine 250 mg/m²/day on day -10;cytarabine 4 g/m²/day on day -9 to -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.
arm group label: Decitabine plus Modified BUCY
intervention type: Drug
intervention name: Modified BUCY
description: Sibling:semustine 250 mg/m²/day on day -9;cytarabine 2 g/m²/day on day -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.
Unrelated:semustine 250 mg/m²/day on day -10;cytarabine 2 g/m²/day on day -9 to -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.
Haploidentical:semustine 250 mg/m²/day on day -10;cytarabine 4 g/m²/day on day -9 to -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.
arm group label: Modified BUCY
criteria: 
gender: All
minimum age: 12 Years
maximum age: 60 Years
healthy volunteers: No
last name: Depei Wu, MD
role: Principal Investigator
affiliation: The First Affiliated Hospital of Soochow University
last name: Xiaowen Tang, MD
phone: +86-512-67781851
email: xwtang1020@163.com
last name: Depei Wu, MD
phone: +86-512-67781851
email: wudepei@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Myeloid
mesh term: Leukemia, Myeloid, Acute
mesh term: Decitabine