<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/NCT02978274</url>
  </required_header>
  <id_info>
    <org_study_id>2016PHB038-01</org_study_id>
    <nct_id>NCT02978274</nct_id>
  </id_info>
  <brief_title>Natural Killer Cells Reconstitution Kinetics Post Haploidentical Transplantation</brief_title>
  <official_title>Natural Killer Cells Reconstitution Kinetics Post T Cells Repleted Haploidentical Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK&#xD;
      cells phenotype and functional reconstitution.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with hematological malignancies suitable for allo-HSCT but without HLA-identical&#xD;
      related or unrelated donors were candidates for the HLA-haploidentical HSCT. Patients&#xD;
      undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK cells&#xD;
      phenotype and functional reconstitution. Peripheral blood will be collected by day15, 30, 60,&#xD;
      90, 180, and 1 year post transplantation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 2015</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Immune Reconstitution differences between two group</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of Infection differences between two group</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of acute GVHD differences between two group</measure>
    <time_frame>100 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of chronic GVHD differences between two group</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of TRM differences between two group</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative incidence of relapse differences between two group</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DFS differences between two group</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS differences between two group</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Natural Killer Cell Mediated Immunity</condition>
  <arm_group>
    <arm_group_label>experimental group</arm_group_label>
    <description>MMF withdrawal by engraftment post haplo-SCT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>MMF withdrawal by 2 month post haplo-SCT</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MMF</intervention_name>
    <description>MMF withdrawal by engraftment post haplo-SCT</description>
    <arm_group_label>experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MMF</intervention_name>
    <description>MMF withdrawal by 2 month post haplo-SCT</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      PB of patients post transplantation&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NR or refractory AML/ALL before transplantation donors from mother or collateral&#xD;
             related&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaojun Huang, M.D., PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiangyu Zhao, M.D., PhD</last_name>
    <phone>+8610-88325949</phone>
    <email>xyz80421@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University Institute of Hematology</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiangyu Zhao, M.D., PhD</last_name>
      <phone>+8610-88325949</phone>
      <email>xyz80421@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>September 30, 2020</last_update_submitted>
  <last_update_submitted_qc>September 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University People's Hospital</investigator_affiliation>
    <investigator_full_name>Xiaojun Huang,MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02978274
org study id: 2016PHB038-01
nct id: NCT02978274
lead sponsor: 
has dmc: Yes
Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK
      cells phenotype and functional reconstitution.
Patients with hematological malignancies suitable for allo-HSCT but without HLA-identical
      related or unrelated donors were candidates for the HLA-haploidentical HSCT. Patients
      undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK cells
      phenotype and functional reconstitution. Peripheral blood will be collected by day15, 30, 60,
      90, 180, and 1 year post transplantation.
observational model: Case-Control
time perspective: Prospective
measure: Immune Reconstitution differences between two group
time frame: 1 year
measure: Cumulative incidence of Infection differences between two group
time frame: 1 year
measure: Cumulative incidence of acute GVHD differences between two group
time frame: 100 day
measure: Cumulative incidence of chronic GVHD differences between two group
time frame: 1 year
measure: Cumulative incidence of TRM differences between two group
time frame: 1 year
measure: Cumulative incidence of relapse differences between two group
time frame: 1 year
measure: DFS differences between two group
time frame: 1 year
measure: OS differences between two group
time frame: 1 year
arm group label: experimental group
description: MMF withdrawal by engraftment post haplo-SCT
arm group label: control group
description: MMF withdrawal by 2 month post haplo-SCT
intervention type: Drug
intervention name: MMF
description: MMF withdrawal by engraftment post haplo-SCT
arm group label: experimental group
intervention type: Drug
intervention name: MMF
description: MMF withdrawal by 2 month post haplo-SCT
arm group label: control group
PB of patients post transplantation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xiaojun Huang, M.D., PhD
role: Study Chair
affiliation: Peking University People's Hospital
last name: Xiangyu Zhao, M.D., PhD
phone: +8610-88325949
email: xyz80421@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University People's Hospital
investigator full name: Xiaojun Huang,MD
investigator title: Professor
sharing ipd: Undecided