<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/NCT01690507</url>
  </required_header>
  <id_info>
    <org_study_id>CN301-XYK-001</org_study_id>
    <nct_id>NCT01690507</nct_id>
  </id_info>
  <brief_title>Decitabine Combining Modified CAG Followed by HLA Haploidentical Peripheral Blood Mononuclear Cells Infusion for Elderly Patients With Acute Myeloid Leukemia(AML）</brief_title>
  <official_title>Phase 1/2 Study of Decitabine Combined With Modified CAG Followed by HLA Haploidentical T Cell Infusion in Treating Elderly Patients With Intermediate-high Risk Myelodysplastic Syndrome(MDS) or Acute Myeloid Leukemia(AML）</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Navy General Hospital, Beijing</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese PLA General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the&#xD;
      expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory&#xD;
      molecules and adhesion molecules. The leukemias cells treated by decitabine will become more&#xD;
      sensitive to the following adoptive T cell therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">May 2015</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>CR rate</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>MDS</condition>
  <condition>AML</condition>
  <arm_group>
    <arm_group_label>DCAG plus HLI</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </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>DCAG plus HLI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cytarabine</intervention_name>
    <arm_group_label>DCAG plus HLI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>aclacinomycin</intervention_name>
    <arm_group_label>DCAG plus HLI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Granulocyte colony-stimulating factor</intervention_name>
    <arm_group_label>DCAG plus HLI</arm_group_label>
    <other_name>G-CSF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HLA haploidentical mononuclear cells infusion</intervention_name>
    <arm_group_label>DCAG plus HLI</arm_group_label>
    <other_name>DLI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        PATIENT Inclusion Criteria:&#xD;
&#xD;
          -  Must have a diagnosis of MDS-RAEB or AML based on 2008 World Health Organization (WHO)&#xD;
             classification of myeloid malignancies&#xD;
&#xD;
          -  Must have life expectancy &gt;= 3 months&#xD;
&#xD;
          -  Must have the ability to observe the efficacy and events&#xD;
&#xD;
          -  Must have no accompany therapy(including steroid)&#xD;
&#xD;
          -  Patient must have ability to understand and willingness to provide written informed&#xD;
             consent prior to participation in the study and any related procedures being performed&#xD;
&#xD;
          -  Must have an Eastern Cooperative Oncology Group (ECOG) performance status =&lt; 3&#xD;
&#xD;
          -  Must have haploidentical donor&#xD;
&#xD;
        DONOR Inclusion Criteria:&#xD;
&#xD;
          -  Must have signed the standard informed consent form; if sufficient cryopreserved cells&#xD;
             remain from a previous donation, no additional donation or consent is required&#xD;
&#xD;
          -  Both men and women and members of all races and ethnic groups are eligible for this&#xD;
             trial&#xD;
&#xD;
        PATIENT Exclusion Criteria:&#xD;
&#xD;
          -  Must not have an advanced malignant hepatic tumor&#xD;
&#xD;
          -  Must not receive any other forms of chemotherapy after cell infusion during the&#xD;
             treatment protocol&#xD;
&#xD;
          -  Must not be receiving any other investigational agents within 14 days of first dose of&#xD;
             study drug&#xD;
&#xD;
          -  Must not have uncontrolled intercurrent illness including ongoing or active infection,&#xD;
             symptomatic congestive heart failure, unstable angina pectoris, or psychiatric&#xD;
             illness/social situations that would limit compliance with study requirements&#xD;
&#xD;
          -  Must not be pregnant or breastfeeding; pregnant women are excluded from this study&#xD;
             because decitabine is a Category D agent with the potential for teratogenic or&#xD;
             abortifacient effects; because there is an unknown but potential risk for adverse&#xD;
             events in nursing infants secondary to treatment of the mother with decitabine,&#xD;
             breastfeeding should be discontinued if the mother is treated with decitabine; these&#xD;
             potential risks may also apply to other agents used in this study&#xD;
&#xD;
          -  Must not have a history of allergic reactions attributed to compounds of similar&#xD;
             chemical or biologic composition to decitabine or other agents used in the study&#xD;
&#xD;
          -  Must not have a known or suspected hypersensitivity to decitabine&#xD;
&#xD;
          -  Must not be human immunodeficiency virus (HIV)-positive and on combination&#xD;
             antiretroviral therapy; these patients are ineligible because of the potential for&#xD;
             pharmacokinetic interactions with decitabine; in addition, these patients are at&#xD;
             increased risk of lethal infections when treated with marrow-suppressive therapy;&#xD;
             appropriate studies will be undertaken in patients receiving combination&#xD;
             antiretroviral therapy when indicated&#xD;
&#xD;
        DONOR Exclusion Criteria:&#xD;
&#xD;
          -  Must not have any underlying conditions which would contra-indicate apheresis&#xD;
&#xD;
          -  Must not be pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li Yu, M.D. Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese PLA General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Navy General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100048</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>February 23, 2016</last_update_submitted>
  <last_update_submitted_qc>February 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>Li Yu</investigator_full_name>
    <investigator_title>Director of Department of Hematology and BMT Center</investigator_title>
  </responsible_party>
  <keyword>demethylating agent</keyword>
  <keyword>immunogenicity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Aclacinomycins</mesh_term>
    <mesh_term>Lenograstim</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/NCT01690507
org study id: CN301-XYK-001
nct id: NCT01690507
lead sponsor: 
collaborator: 
has dmc: No
Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the
      expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory
      molecules and adhesion molecules. The leukemias cells treated by decitabine will become more
      sensitive to the following adoptive T cell therapy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: CR rate
time frame: 3 months
measure: overall survival
time frame: 2 years
arm group label: DCAG plus HLI
arm group type: Other
intervention type: Drug
intervention name: Decitabine
description: 20 mg/m²/day for 5 days
arm group label: DCAG plus HLI
intervention type: Drug
intervention name: Cytarabine
arm group label: DCAG plus HLI
intervention type: Drug
intervention name: aclacinomycin
arm group label: DCAG plus HLI
intervention type: Drug
intervention name: Granulocyte colony-stimulating factor
arm group label: DCAG plus HLI
other name: G-CSF
intervention type: Other
intervention name: HLA haploidentical mononuclear cells infusion
arm group label: DCAG plus HLI
other name: DLI
criteria: 
gender: All
minimum age: 55 Years
maximum age: 75 Years
healthy volunteers: No
last name: Li Yu, M.D. Ph.D.
role: Principal Investigator
affiliation: Chinese PLA General Hospital
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: Li Yu
investigator title: Director of Department of Hematology and BMT Center
mesh term: Leukemia, Myeloid, Acute
mesh term: Cytarabine
mesh term: Decitabine
mesh term: Aclacinomycins
mesh term: Lenograstim