<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/NCT03297528</url>
  </required_header>
  <id_info>
    <org_study_id>PUPH2017-2-21</org_study_id>
    <nct_id>NCT03297528</nct_id>
  </id_info>
  <brief_title>Chemotherapy and DLI for Prevention of Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant</brief_title>
  <official_title>Multiple Consolidation Chemotherapy and DLI Prevent Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant and Achieving Complete Remission After Induction Chemotherapy and DLI</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with acute leukemia relapsing after allotransplant and who respond to anti-leukaemia&#xD;
      interventions are at high-risk of a second relapse. Previous studies from investigators&#xD;
      reported an association between a positive minimal residual disease (MRD)-test after&#xD;
      transplant and an increased risk of subsequent relapse. Also, patients developing chronic&#xD;
      graft-versus-host disease (GvHD) after receiving DLI (donor lymphocyte infusion)for leukemia&#xD;
      relapse after a first allotransplant have a lower likelihood of a second relapse compared&#xD;
      with similar patients not developing chronic GvHD. And, our previous study also reported&#xD;
      patients with chronic GvHD after DLI was associated with a greater frequency of a negative&#xD;
      MRD-test and lower likelihood of subsequent relapse compared with similar persons not&#xD;
      developing chronic GvHD. Based on these data the investigators designed a randomized control&#xD;
      study to determine whether giving additional consolidation chemotherapy and DLI might&#xD;
      decrease likelihood of second relapse in persons without chronic GvHD or with a positive&#xD;
      MRD-test after initial post-relapse therapy with induction chemotherapy and DLI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2020</primary_completion_date>
  <phase>Phase 2</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>Number of participants with a positive results of minimal residual disease that is evaluated by testing aberrant leukemia-associated immune phenotypes and WT1 mRNA levels.</measure>
    <time_frame>one year</time_frame>
    <description>Investigators use two strategies to test for minimal residual disease in bone marrow samples: (1) aberrant leukemia-associated immune phenotypes detected by 4 colour flow cytometry; and (2) WT1 mRNA levels detected by polymerase chain reaction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants who relapsed</measure>
    <time_frame>one year</time_frame>
    <description>Relapse was defined as recurrence of ≥5% bone marrow blasts or of ≥1 extra-medullary sites of leukaemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of surviving participants</measure>
    <time_frame>one year</time_frame>
    <description>The outcomes of participants are recored until one year</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Donor Lymphocyte Infusion</condition>
  <condition>Allogeneic Hematopoietic Stem Cell Transplantation</condition>
  <condition>Acute Leukemia</condition>
  <condition>Minimal Residual Disease</condition>
  <condition>Graft-versus-host Disease</condition>
  <condition>Relapse</condition>
  <arm_group>
    <arm_group_label>study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive chemotherapy and donor lymphocyte infusions based on the state GvHD, even the participants have a negative result of minimal residual disease (MRD). If the participants have no GvHD,they will receive chemotherapy and donor lymphocyte infusion until they develop GvHD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants don't receive chemotherapy and donor lymphocyte infusion as long as they have a negative result of MRD,in dispite of whether or not GvHD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>donor lymphocyte infusion</intervention_name>
    <description>Participants in study group receive chemotherapy and donor lymphocyte infusion based on the state of GvHD, even they have a negative result of MRD. If participants in study group have no GvHD, they will receive chemotherapy and donor lymphocyte infusion until they develop GvHD. If the participants in study group have GvHD, they will be observed. But, the participants in control group don't receive chemotherapy and donor lymphocyte infusion as long as they have a negative result of MRD, in despite of whether or not GvHD.</description>
    <arm_group_label>study group</arm_group_label>
    <other_name>chemotherapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) acute leukemia in first complete or second complete remission;&#xD;
&#xD;
          -  (2) relapse after an allotransplant;&#xD;
&#xD;
          -  (3) had full or partial donor chimerism;&#xD;
&#xD;
          -  (4) received re-induction chemotherapy and DLI and achieved a negative MRD-test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) active GvHD&#xD;
&#xD;
          -  (2) active infection&#xD;
&#xD;
          -  (3) organ dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiao-jun Huang</last_name>
    <role>Study Director</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chen-hua Yan, Dr</last_name>
    <phone>8610-82816999</phone>
    <email>yanchenhua@vip.sina.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yu Wang, Dr</last_name>
    <phone>8610-82816999</phone>
    <email>ywyw3172@sina.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking University Institute of Hematology,Beijing</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chen-hua Yan</last_name>
      <email>yanchenhua@vip.sina.com</email>
    </contact>
    <investigator>
      <last_name>Xiao-Jun Huang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>February 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Neoplasm, Residual</mesh_term>
    <mesh_term>Graft vs Host Disease</mesh_term>
    <mesh_term>Recurrence</mesh_term>
    <mesh_term>Acute Disease</mesh_term>
  </condition_browse>
  <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/NCT03297528
org study id: PUPH2017-2-21
nct id: NCT03297528
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Patients with acute leukemia relapsing after allotransplant and who respond to anti-leukaemia
      interventions are at high-risk of a second relapse. Previous studies from investigators
      reported an association between a positive minimal residual disease (MRD)-test after
      transplant and an increased risk of subsequent relapse. Also, patients developing chronic
      graft-versus-host disease (GvHD) after receiving DLI (donor lymphocyte infusion)for leukemia
      relapse after a first allotransplant have a lower likelihood of a second relapse compared
      with similar patients not developing chronic GvHD. And, our previous study also reported
      patients with chronic GvHD after DLI was associated with a greater frequency of a negative
      MRD-test and lower likelihood of subsequent relapse compared with similar persons not
      developing chronic GvHD. Based on these data the investigators designed a randomized control
      study to determine whether giving additional consolidation chemotherapy and DLI might
      decrease likelihood of second relapse in persons without chronic GvHD or with a positive
      MRD-test after initial post-relapse therapy with induction chemotherapy and DLI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of participants with a positive results of minimal residual disease that is evaluated by testing aberrant leukemia-associated immune phenotypes and WT1 mRNA levels.
time frame: one year
description: Investigators use two strategies to test for minimal residual disease in bone marrow samples: (1) aberrant leukemia-associated immune phenotypes detected by 4 colour flow cytometry; and (2) WT1 mRNA levels detected by polymerase chain reaction.
measure: Number of participants who relapsed
time frame: one year
description: Relapse was defined as recurrence of ≥5% bone marrow blasts or of ≥1 extra-medullary sites of leukaemia.
measure: Number of surviving participants
time frame: one year
description: The outcomes of participants are recored until one year
arm group label: study group
arm group type: Experimental
description: Participants receive chemotherapy and donor lymphocyte infusions based on the state GvHD, even the participants have a negative result of minimal residual disease (MRD). If the participants have no GvHD,they will receive chemotherapy and donor lymphocyte infusion until they develop GvHD.
arm group label: control group
arm group type: No Intervention
description: Participants don't receive chemotherapy and donor lymphocyte infusion as long as they have a negative result of MRD,in dispite of whether or not GvHD.
intervention type: Drug
intervention name: donor lymphocyte infusion
description: Participants in study group receive chemotherapy and donor lymphocyte infusion based on the state of GvHD, even they have a negative result of MRD. If participants in study group have no GvHD, they will receive chemotherapy and donor lymphocyte infusion until they develop GvHD. If the participants in study group have GvHD, they will be observed. But, the participants in control group don't receive chemotherapy and donor lymphocyte infusion as long as they have a negative result of MRD, in despite of whether or not GvHD.
arm group label: study group
other name: chemotherapy
criteria: 
gender: All
minimum age: 5 Years
maximum age: 60 Years
healthy volunteers: No
last name: Xiao-jun Huang
role: Study Director
affiliation: Peking University People's Hospital
last name: Chen-hua Yan, Dr
phone: 8610-82816999
email: yanchenhua@vip.sina.com
last name: Yu Wang, Dr
phone: 8610-82816999
email: ywyw3172@sina.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University People's Hospital
investigator full name: Xiaojun Huang,MD
investigator title: Professor
mesh term: Leukemia
mesh term: Neoplasm, Residual
mesh term: Graft vs Host Disease
mesh term: Recurrence
mesh term: Acute Disease
sharing ipd: Undecided