<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/NCT03792815</url>
  </required_header>
  <id_info>
    <org_study_id>SCH HMO</org_study_id>
    <nct_id>NCT03792815</nct_id>
  </id_info>
  <brief_title>Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation for Non-Hodgkin's Lymphoma (NHL)</brief_title>
  <acronym>BME</acronym>
  <official_title>Open-labelled, Multicenter Phase II Clinical Trial of Intravenous Busulfan, Melphalan and Etoposide as Conditioning for Autologous Transplantation in Patients With Poor-risk, Refractory or Relapsed Non-Hodgkin's Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Soonchunhyang University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Soonchunhyang University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators developed a protocol utilizing once-daily intravenous&#xD;
      busulfan/melphalan/etoposide regimen as a conditioning for high-dose therapy (HDT) in the&#xD;
      patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Treatment:&#xD;
&#xD;
      busulfan 3.2 mg/kg/day i.v. on day -7, -6, and -5 etoposide 400 mg/m2 i.v. on day -5 and -4&#xD;
      melphalan 50mg/m2/day i.v. on day -3 and -2&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2009</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">November 2011</primary_completion_date>
  <phase>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>rate of event free survival</measure>
    <time_frame>from date of ASCT until the the time of disease progression, relapse, or death, whichever came first, assessed at least 2 years</time_frame>
    <description>calculate from the date of ASCT until the time of disease progression, relapse, or death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>rate of event free survival</measure>
    <time_frame>at least 2 years</time_frame>
    <description>calculate from the date of ASCT until the time of death from any causes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of regimen related toxicity</measure>
    <time_frame>up to 6 months</time_frame>
    <description>calculate toxicities</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Non-Hodgkin's Lymphoma</condition>
  <arm_group>
    <arm_group_label>busulfan melphalan etoposide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>busulfan 3.2 mg/kg/day i.v. on day -7, -6, and -5 etoposide 400 mg/m2 i.v. on day -5 and -4 melphalan 50mg/m2/day i.v. on day -3 and -2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Busulfan</intervention_name>
    <description>busulfan 3.2mg/kg iv on day -8, -7, and -6,</description>
    <arm_group_label>busulfan melphalan etoposide</arm_group_label>
    <other_name>Busulfex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melphalan</intervention_name>
    <description>melphalan 50mg/m2/day i.v. on day -3 and -2</description>
    <arm_group_label>busulfan melphalan etoposide</arm_group_label>
    <other_name>Alkeran</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etoposide</intervention_name>
    <description>etoposide 400 mg/m2 i.v. on day -5 and -4</description>
    <arm_group_label>busulfan melphalan etoposide</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. Histologically confirmed aggressive NHL&#xD;
&#xD;
          2. Mantle cell lymphoma&#xD;
&#xD;
          3. salvage chemotherapy sensitive relapse/refractory NHL&#xD;
&#xD;
          4. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2.&#xD;
&#xD;
          5. Age; 18-65&#xD;
&#xD;
          6. Adequate renal function: serum creatinine ≤ 1.5mg/dL&#xD;
&#xD;
          7. Adequate liver functions: Transaminase (AST/ALT) &lt; 3 X upper normal value &amp; Bilirubin&#xD;
             &lt; 2 X upper normal value&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. low grade NHL&#xD;
&#xD;
          2. Any other malignancies within the past 5 years except curatively treated non-melanoma&#xD;
             skin cancer or in situ carcinoma of cervix uteri&#xD;
&#xD;
          3. Other serious illness or medical conditions&#xD;
&#xD;
               -  Unstable cardiac disease despite treatment, myocardial infarction within 6 months&#xD;
                  prior to study entry&#xD;
&#xD;
               -  History of significant neurological or psychiatric disorders&#xD;
&#xD;
               -  Active uncontrolled infection (viral, bacterial or fungal infection)&#xD;
&#xD;
          4. Pregnant or lactating women, women of childbearing potential not employing adequate&#xD;
             contraception&#xD;
&#xD;
          5. HIV (+)&#xD;
&#xD;
          6. Patients who have hepatitis B virus (HBV) (+) are eligible. However, primary&#xD;
             prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to&#xD;
             prevent HBV reactivation during whole treatment period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jong-Ho Won, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Soonchunhyang University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Soonchunhyang University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>140-743</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>February 16, 2010</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 2, 2019</last_update_submitted>
  <last_update_submitted_qc>January 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Soonchunhyang University Hospital</investigator_affiliation>
    <investigator_full_name>Jong-Ho Won</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Transplantation Conditioning</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Etoposide</mesh_term>
    <mesh_term>Melphalan</mesh_term>
    <mesh_term>Busulfan</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/NCT03792815
org study id: SCH HMO
nct id: NCT03792815
lead sponsor: 
has dmc: No
The investigators developed a protocol utilizing once-daily intravenous
      busulfan/melphalan/etoposide regimen as a conditioning for high-dose therapy (HDT) in the
      patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).
Treatment:

      busulfan 3.2 mg/kg/day i.v. on day -7, -6, and -5 etoposide 400 mg/m2 i.v. on day -5 and -4
      melphalan 50mg/m2/day i.v. on day -3 and -2
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: rate of event free survival
time frame: from date of ASCT until the the time of disease progression, relapse, or death, whichever came first, assessed at least 2 years
description: calculate from the date of ASCT until the time of disease progression, relapse, or death
measure: rate of event free survival
time frame: at least 2 years
description: calculate from the date of ASCT until the time of death from any causes
measure: rate of regimen related toxicity
time frame: up to 6 months
description: calculate toxicities
arm group label: busulfan melphalan etoposide
arm group type: Experimental
description: busulfan 3.2 mg/kg/day i.v. on day -7, -6, and -5 etoposide 400 mg/m2 i.v. on day -5 and -4 melphalan 50mg/m2/day i.v. on day -3 and -2
intervention type: Drug
intervention name: Busulfan
description: busulfan 3.2mg/kg iv on day -8, -7, and -6,
arm group label: busulfan melphalan etoposide
other name: Busulfex
intervention type: Drug
intervention name: Melphalan
description: melphalan 50mg/m2/day i.v. on day -3 and -2
arm group label: busulfan melphalan etoposide
other name: Alkeran
intervention type: Drug
intervention name: Etoposide
description: etoposide 400 mg/m2 i.v. on day -5 and -4
arm group label: busulfan melphalan etoposide
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jong-Ho Won, Professor
role: Principal Investigator
affiliation: Soonchunhyang University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Soonchunhyang University Hospital
investigator full name: Jong-Ho Won
investigator title: professor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Etoposide
mesh term: Melphalan
mesh term: Busulfan
sharing ipd: Undecided