<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/NCT02185261</url>
  </required_header>
  <id_info>
    <org_study_id>2014-02</org_study_id>
    <nct_id>NCT02185261</nct_id>
  </id_info>
  <brief_title>Interferon α for the Therapy of Minimal Residual Disease</brief_title>
  <official_title>Interferon α for the Therapy of Minimal Residual Disease Following Hematopoietic Stem Cell 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>
      This study aimed to evaluate the efficacy of interferon α among patients undergone&#xD;
      unmanipulated blood and marrow transplantation following day 60 post-transplantation who were&#xD;
      minimal residual disease positive after transplantation.&#xD;
&#xD;
      Hematopoietic stem cell transplantation (HSCT) is an effective treatment option for acute&#xD;
      leukemia and many other hematological malignancies. However, post-transplant relapse can&#xD;
      occur in some patients, and the prognosis of these patients is usually very poor.The&#xD;
      persistence or recurrence of minimal residual disease (MRD) in the post-transplant period is&#xD;
      an independent risk factor of relapse. Therefore, MRD monitoring can be used to screen&#xD;
      patients with a high risk of relapse to provide timely intervention and prevent&#xD;
      post-transplant relapse.Interferon α-2b exerts a relatively strong immunomodulatory effect.&#xD;
      It can kill acute leukemia (AL) cells by regulating T-cell and/or natural killer cell&#xD;
      functions.Consequently, interferon α-2b may have potential therapeutic value for AL patients&#xD;
      with MRD-positive after transplantation.&#xD;
&#xD;
      The study hypothesis:&#xD;
&#xD;
      Prevention of relapse using interferon α-2b following hematopoietic stem cell transplantation&#xD;
      in patients with standard risk acute leukemia can reduce relapse rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Standard risk acute leukemia patients (except t(9;22)(q34; q11), t(15;17), inv(16)(p13q22),&#xD;
      t(16;16)(p13; q22), or t(8;21)(q22; q22) cytogenetic abnormalities.) undergone unmanipulated&#xD;
      blood and marrow transplantation following day 60 post-transplantation who were minimal&#xD;
      residual disease positive after hematopoietic stem cell transplantation received interferon&#xD;
      α-2b. The end points were safety and immunologic response. Following time is 12 months.&#xD;
&#xD;
      Primary Outcome Measures:&#xD;
&#xD;
      *The feasibility and efficacy of administering of subcutaneous interferon α-2b in this&#xD;
      patient population. [ Time Frame: 1 years ]&#xD;
&#xD;
      Secondary Outcome Measures:&#xD;
&#xD;
      *The immunologic impact and clinical outcomes of subcutaneous interferon α-2b in patients&#xD;
      after unmanipulated blood and marrow transplantation [ Time Frame: 1 years ] Estimated&#xD;
      Enrollment:81 Study Start Date: Jun 2014 Estimated Study Completion Date: Jun 2016&#xD;
&#xD;
      Intervention Details Description:&#xD;
&#xD;
      *Drug:Interferon α-2b (subcutaneously at dosages of 3 million units 2-3 times per week) for 6&#xD;
      months in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      Acute leukemia patients who were MRD positive after day 60 post-transplantation receive&#xD;
      interferon α-2b(subcutaneously at dosages of 3 million units 2-3 times per week). Interferon&#xD;
      α-2b continues for 6 months in the absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      Participants will be seen periodically while they are receiving interferon α-2b. Physical&#xD;
      exams and blood tests will be performed weekly for the first two weeks and then every other&#xD;
      week until the completion of 6 months therapy.&#xD;
&#xD;
      Eligibility Ages Eligible for Study: 1-60 Years Genders Eligible for Study: Both Accepts&#xD;
      Healthy Volunteers: No Criteria&#xD;
&#xD;
      The trial will be terminated in following situation&#xD;
&#xD;
        1. Severe toxicity occurrence&#xD;
&#xD;
        2. Cumulative incidence of relapse increased) (≥ 30%)&#xD;
&#xD;
        3. Cumulative incidence of mortality increased (≥ 30%)&#xD;
&#xD;
        4. Cumulative incidence of severe graft-versus-host disease increased (≥ 30%)&#xD;
&#xD;
        5. Although large enough sample had been enrolled, it did not reach statistical&#xD;
           significance&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</primary_completion_date>
  <phase>N/A</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>relapse rate</measure>
    <time_frame>participants will be followed for an expected average of 1 year</time_frame>
    <description>number of participants with morphologic relapse at one year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The immunologic impact of subcutaneous interferon α-2b</measure>
    <time_frame>participants will be followed for an expected average of 1 year</time_frame>
    <description>examine the immune reconstitution of subgroups of T cells and nature killer cells after interferon α-2b application</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">81</enrollment>
  <condition>Leukemia</condition>
  <arm_group>
    <arm_group_label>interferon Alfa-2b group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acute leukemia patients who are minimal residual disease positive after hematopoietic stem cell transplantation receive interferon Alfa-2b</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Interferon Alfa-2b</intervention_name>
    <description>Patients who were deemed MRD-positive after day 60 post-transplantation receive interferon α-2b (subcutaneously at dosages of 3 million units 2-3 times per week) . Interferon treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.</description>
    <arm_group_label>interferon Alfa-2b group</arm_group_label>
    <other_name>INF α-2b</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who had standard-risk acute myeloid leukemia(CR1 or CR2) had minimal residual&#xD;
             disease positive after hematopoietic stem cell transplantation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with t(9;22)(q34; q11), t(15;17), inv(16)(p13q22), t(16;16)(p13; q22), or&#xD;
             t(8;21)(q22; q22) cytogenetic abnormalities;active graft-versus-host disease; active&#xD;
             infection; organ failure; exposure to donor lymphocyte infusion prior to enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiao-Jun Huang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Institute of Hematology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiao-Dong Mo, MD</last_name>
    <email>mxd453@163.com</email>
  </overall_contact>
  <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>Xiao-Dong Mo</last_name>
      <email>mxd453@163.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>June 2018</verification_date>
  <study_first_submitted>February 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>June 6, 2018</last_update_submitted>
  <last_update_submitted_qc>June 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2018</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</investigator_full_name>
    <investigator_title>Peking University Institute of Hematology</investigator_title>
  </responsible_party>
  <keyword>Relapse</keyword>
  <keyword>Minimal residual disease</keyword>
  <keyword>Graft-versus-host disease</keyword>
  <keyword>Acute leukemia</keyword>
  <keyword>Interferon Alfa-2b</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm, Residual</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interferons</mesh_term>
    <mesh_term>Interferon-alpha</mesh_term>
    <mesh_term>Interferon alpha-2</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/NCT02185261
org study id: 2014-02
nct id: NCT02185261
lead sponsor: 
has dmc: Yes
This study aimed to evaluate the efficacy of interferon α among patients undergone
      unmanipulated blood and marrow transplantation following day 60 post-transplantation who were
      minimal residual disease positive after transplantation.

      Hematopoietic stem cell transplantation (HSCT) is an effective treatment option for acute
      leukemia and many other hematological malignancies. However, post-transplant relapse can
      occur in some patients, and the prognosis of these patients is usually very poor.The
      persistence or recurrence of minimal residual disease (MRD) in the post-transplant period is
      an independent risk factor of relapse. Therefore, MRD monitoring can be used to screen
      patients with a high risk of relapse to provide timely intervention and prevent
      post-transplant relapse.Interferon α-2b exerts a relatively strong immunomodulatory effect.
      It can kill acute leukemia (AL) cells by regulating T-cell and/or natural killer cell
      functions.Consequently, interferon α-2b may have potential therapeutic value for AL patients
      with MRD-positive after transplantation.

      The study hypothesis:

      Prevention of relapse using interferon α-2b following hematopoietic stem cell transplantation
      in patients with standard risk acute leukemia can reduce relapse rate.
Standard risk acute leukemia patients (except t(9;22)(q34; q11), t(15;17), inv(16)(p13q22),
      t(16;16)(p13; q22), or t(8;21)(q22; q22) cytogenetic abnormalities.) undergone unmanipulated
      blood and marrow transplantation following day 60 post-transplantation who were minimal
      residual disease positive after hematopoietic stem cell transplantation received interferon
      α-2b. The end points were safety and immunologic response. Following time is 12 months.

      Primary Outcome Measures:

      *The feasibility and efficacy of administering of subcutaneous interferon α-2b in this
      patient population. [ Time Frame: 1 years ]

      Secondary Outcome Measures:

      *The immunologic impact and clinical outcomes of subcutaneous interferon α-2b in patients
      after unmanipulated blood and marrow transplantation [ Time Frame: 1 years ] Estimated
      Enrollment:81 Study Start Date: Jun 2014 Estimated Study Completion Date: Jun 2016

      Intervention Details Description:

      *Drug:Interferon α-2b (subcutaneously at dosages of 3 million units 2-3 times per week) for 6
      months in the absence of disease progression or unacceptable toxicity.

      Acute leukemia patients who were MRD positive after day 60 post-transplantation receive
      interferon α-2b(subcutaneously at dosages of 3 million units 2-3 times per week). Interferon
      α-2b continues for 6 months in the absence of disease progression or unacceptable toxicity.

      Participants will be seen periodically while they are receiving interferon α-2b. Physical
      exams and blood tests will be performed weekly for the first two weeks and then every other
      week until the completion of 6 months therapy.

      Eligibility Ages Eligible for Study: 1-60 Years Genders Eligible for Study: Both Accepts
      Healthy Volunteers: No Criteria

      The trial will be terminated in following situation

        1. Severe toxicity occurrence

        2. Cumulative incidence of relapse increased) (≥ 30%)

        3. Cumulative incidence of mortality increased (≥ 30%)

        4. Cumulative incidence of severe graft-versus-host disease increased (≥ 30%)

        5. Although large enough sample had been enrolled, it did not reach statistical
           significance
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: relapse rate
time frame: participants will be followed for an expected average of 1 year
description: number of participants with morphologic relapse at one year
measure: The immunologic impact of subcutaneous interferon α-2b
time frame: participants will be followed for an expected average of 1 year
description: examine the immune reconstitution of subgroups of T cells and nature killer cells after interferon α-2b application
arm group label: interferon Alfa-2b group
arm group type: Experimental
description: Acute leukemia patients who are minimal residual disease positive after hematopoietic stem cell transplantation receive interferon Alfa-2b
intervention type: Drug
intervention name: Interferon Alfa-2b
description: Patients who were deemed MRD-positive after day 60 post-transplantation receive interferon α-2b (subcutaneously at dosages of 3 million units 2-3 times per week) . Interferon treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
arm group label: interferon Alfa-2b group
other name: INF α-2b
criteria: 
gender: All
minimum age: 1 Year
maximum age: 60 Years
healthy volunteers: No
last name: Xiao-Jun Huang, MD
role: Principal Investigator
affiliation: Peking University Institute of Hematology
last name: Xiao-Dong Mo, MD
email: mxd453@163.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
investigator title: Peking University Institute of Hematology
mesh term: Neoplasm, Residual
mesh term: Interferons
mesh term: Interferon-alpha
mesh term: Interferon alpha-2