<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/NCT03229616</url>
  </required_header>
  <id_info>
    <org_study_id>BUCY+VP-16 vs BUCY-DLBCL-2017</org_study_id>
    <nct_id>NCT03229616</nct_id>
  </id_info>
  <brief_title>BUCY+VP-16 vs BUCY Conditioning Regimen for DLBCL Undergoing Auto-HSCT</brief_title>
  <official_title>Busulfan+ Cyclophosphamide+ Etoposide vs Busulfan+ Cyclophosphamide Conditioning Regimen for Diffuse Large B-cell Lymphoma Undergoing Autologous Hematopoietic Stem Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangzhou First People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhujiang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Third Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of BUCY+VP-16 and BUCY&#xD;
      myeloablative conditioning regimens in diffuse large B-cell lymphoma undergoing autologous&#xD;
      hematopoietic stem cell transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective therapy for&#xD;
      diffuse large B-cell lymphoma (DLBCL).BuCY conditioning regimen is a conventional scheme for&#xD;
      DLBCL patients undergoing auto-HSCT, but it has a high relapse rate. Etoposide (VP-16) is&#xD;
      extensively used in chemotherapy regimen for refractory/relapsed lymphoma. Whether addition&#xD;
      of VP-16 could reduce the relapse rate remains unclear.In this study, the safety and efficacy&#xD;
      of BUCY+VP-16 and BUCY myeloablative conditioning regimens in DLBCL undergoing auto-HSCT are&#xD;
      evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 5, 2017</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>relapse rate</measure>
    <time_frame>2 year</time_frame>
    <description>relapse rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DFS</measure>
    <time_frame>2 year</time_frame>
    <description>disease-free survival (DFS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>2 year</time_frame>
    <description>overall survival (OS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TRM</measure>
    <time_frame>2 year</time_frame>
    <description>transplant-related mortality (TRM)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">122</enrollment>
  <condition>Autologous Hematopoietic Stem Cell Transplantation</condition>
  <condition>Diffuse Large B-cell Lymphoma</condition>
  <condition>Conditioning</condition>
  <arm_group>
    <arm_group_label>BUCY+VP-16</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For DLBCL patients undergoing auto-HSCT，BUCY+VP-16 conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2; VP-16 15mg/kg/day on days -3 and -2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BUCY</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For DLBCL patients undergoing auto-HSCT，BUCY conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Busulfan (BU)</intervention_name>
    <description>Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.</description>
    <arm_group_label>BUCY</arm_group_label>
    <arm_group_label>BUCY+VP-16</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide (CY)</intervention_name>
    <description>Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.</description>
    <arm_group_label>BUCY</arm_group_label>
    <arm_group_label>BUCY+VP-16</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etoposide (VP-16)</intervention_name>
    <description>Etoposide was administered at 15 mg/kg/day on days -3 to -2.</description>
    <arm_group_label>BUCY+VP-16</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diffuse large B-cell lymphoma patients&#xD;
&#xD;
          -  Achieving CR or PR after four cycles of chemotherapy, then mobilizing and collecting&#xD;
             of peripheral blood stem cells and receiving one cycle of chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood&#xD;
             pressure)&#xD;
&#xD;
          -  Patients with any conditions not suitable for the trial (investigators' decision&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qifa Liu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nanfang Hospital, Southern Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Qifa Liu</last_name>
    <phone>+862061641611</phone>
    <email>liuqifa628@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Hematology,Nanfang Hospital, Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Xuan</last_name>
      <phone>+86-020-61641613</phone>
      <email>356135708@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanfang Hospital, Southern Medical University</investigator_affiliation>
    <investigator_full_name>Qifa Liu</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>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Lymphoma, Large B-Cell, Diffuse</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Busulfan</mesh_term>
    <mesh_term>Etoposide</mesh_term>
  </intervention_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/NCT03229616
org study id: BUCY+VP-16 vs BUCY-DLBCL-2017
nct id: NCT03229616
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the safety and efficacy of BUCY+VP-16 and BUCY
      myeloablative conditioning regimens in diffuse large B-cell lymphoma undergoing autologous
      hematopoietic stem cell transplantation.
Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective therapy for
      diffuse large B-cell lymphoma (DLBCL).BuCY conditioning regimen is a conventional scheme for
      DLBCL patients undergoing auto-HSCT, but it has a high relapse rate. Etoposide (VP-16) is
      extensively used in chemotherapy regimen for refractory/relapsed lymphoma. Whether addition
      of VP-16 could reduce the relapse rate remains unclear.In this study, the safety and efficacy
      of BUCY+VP-16 and BUCY myeloablative conditioning regimens in DLBCL undergoing auto-HSCT are
      evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: relapse rate
time frame: 2 year
description: relapse rate
measure: DFS
time frame: 2 year
description: disease-free survival (DFS)
measure: OS
time frame: 2 year
description: overall survival (OS)
measure: TRM
time frame: 2 year
description: transplant-related mortality (TRM)
arm group label: BUCY+VP-16
arm group type: Experimental
description: For DLBCL patients undergoing auto-HSCT，BUCY+VP-16 conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2; VP-16 15mg/kg/day on days -3 and -2.
arm group label: BUCY
arm group type: Active Comparator
description: For DLBCL patients undergoing auto-HSCT，BUCY conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2.
intervention type: Drug
intervention name: Busulfan (BU)
description: Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
arm group label: BUCY
arm group label: BUCY+VP-16
intervention type: Drug
intervention name: Cyclophosphamide (CY)
description: Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
arm group label: BUCY
arm group label: BUCY+VP-16
intervention type: Drug
intervention name: Etoposide (VP-16)
description: Etoposide was administered at 15 mg/kg/day on days -3 to -2.
arm group label: BUCY+VP-16
criteria: 
gender: All
minimum age: 14 Years
maximum age: 65 Years
healthy volunteers: No
last name: Qifa Liu
role: Principal Investigator
affiliation: Nanfang Hospital, Southern Medical University
last name: Qifa Liu
phone: +862061641611
email: liuqifa628@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanfang Hospital, Southern Medical University
investigator full name: Qifa Liu
investigator title: Professor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Cyclophosphamide
mesh term: Busulfan
mesh term: Etoposide
sharing ipd: Undecided