<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/NCT01674985</url>
  </required_header>
  <id_info>
    <org_study_id>MST/MDS-307PLAH-ASH</org_study_id>
    <nct_id>NCT01674985</nct_id>
  </id_info>
  <brief_title>Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Affiliated Hospital of the Chinese Academy of Military Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Second Artillery General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Affiliated Hospital of the Chinese Academy of Military Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate whether infusion of G-CSF mobilized&#xD;
      HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine&#xD;
      chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>Phase 1/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>complete remission</measure>
    <time_frame>six months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>disease-free survival</measure>
    <time_frame>three years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>overall survival</measure>
    <time_frame>three years</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Myelodysplastic Syndromes</condition>
  <arm_group>
    <arm_group_label>Decitabine and cytarabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>induction therapy：decitabine 25mg/m2 daily for 4 days with cytarabine 150 mg/m2 daily for 7 days consolidation：decitabine 25mg/m2 daily for 4 days with cytarabine 2g/m2 q12h for 3 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Microtransplantation</intervention_name>
    <description>Infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC)</description>
    <arm_group_label>Decitabine and cytarabine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients 10 to 90 years old with primary or treatment-related MDS or chronic&#xD;
             myelomonocytic leukemia;&#xD;
&#xD;
          -  International Prognostic Scoring System(IPSS) intermediate-1,intermediate-2,or high&#xD;
             risk;&#xD;
&#xD;
          -  bone marrow blasts &gt; 11% or &lt;= 10% and poor cytogenetics;&#xD;
&#xD;
          -  lack of an HLA-identical donor;&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2;&#xD;
&#xD;
          -  adequate cardiac and hepatorenal functions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have an HLA-identical donor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheng Hui Ai, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Affiliated Hospital of Academy of Military Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Affiliated Hospital of Academy of Military Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100071</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Guo M, Hu KX, Yu CL, Sun QY, Qiao JH, Wang DH, Liu GX, Sun WJ, Wei L, Sun XD, Huang YJ, Qiao JX, Dong Z, Ai HS. Infusion of HLA-mismatched peripheral blood stem cells improves the outcome of chemotherapy for acute myeloid leukemia in elderly patients. Blood. 2011 Jan 20;117(3):936-41. doi: 10.1182/blood-2010-06-288506. Epub 2010 Oct 21.</citation>
    <PMID>20966170</PMID>
  </reference>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>August 25, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>July 12, 2016</last_update_submitted>
  <last_update_submitted_qc>July 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Decitabine</keyword>
  <keyword>microtransplantation</keyword>
  <keyword>myelodysplastic syndromes</keyword>
  <keyword>chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Preleukemia</mesh_term>
    <mesh_term>Myelodysplastic Syndromes</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_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/NCT01674985
org study id: MST/MDS-307PLAH-ASH
nct id: NCT01674985
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate whether infusion of G-CSF mobilized
      HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine
      chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: complete remission
time frame: six months
measure: disease-free survival
time frame: three years
measure: overall survival
time frame: three years
arm group label: Decitabine and cytarabine
arm group type: Experimental
description: induction therapy：decitabine 25mg/m2 daily for 4 days with cytarabine 150 mg/m2 daily for 7 days consolidation：decitabine 25mg/m2 daily for 4 days with cytarabine 2g/m2 q12h for 3 days
intervention type: Biological
intervention name: Microtransplantation
description: Infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC)
arm group label: Decitabine and cytarabine
criteria: 
gender: All
minimum age: 10 Years
maximum age: 90 Years
healthy volunteers: No
last name: Sheng Hui Ai, M.D
role: Principal Investigator
affiliation: Affiliated Hospital of Academy of Military Medical Sciences
facility: 
country: China
citation: Guo M, Hu KX, Yu CL, Sun QY, Qiao JH, Wang DH, Liu GX, Sun WJ, Wei L, Sun XD, Huang YJ, Qiao JX, Dong Z, Ai HS. Infusion of HLA-mismatched peripheral blood stem cells improves the outcome of chemotherapy for acute myeloid leukemia in elderly patients. Blood. 2011 Jan 20;117(3):936-41. doi: 10.1182/blood-2010-06-288506. Epub 2010 Oct 21.
PMID: 20966170
responsible party type: Sponsor
mesh term: Preleukemia
mesh term: Myelodysplastic Syndromes
mesh term: Syndrome