<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/NCT03794167</url>
  </required_header>
  <id_info>
    <org_study_id>CISL 12-05</org_study_id>
    <nct_id>NCT03794167</nct_id>
  </id_info>
  <brief_title>BuCE Versus BuME as Conditioning Therapy in Non-Hodgkin's Lymphoma</brief_title>
  <acronym>CISL</acronym>
  <official_title>Randomized Phase II Multi-center Trial of Busulfan, Etoposide, and Cyclophosphamide Versus Busulfan, Etoposide, and Melphalan as Conditioning Therapy for Autologous Stem-cell Transplantation(ASCT) in Patients With 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators developed a protocol comparing busulfan/cyclophosphamide/etoposide (BuCE)&#xD;
      and busulfan/melphalan/etoposide (BuME) regimen as a conditioning for high-dose therapy (HDT)&#xD;
      in the patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intravenous busulfan containing regimens as conditioning regimen have been used for both&#xD;
      allogeneic and autologous stem cell transplantation in patients with hematologic and&#xD;
      non-hematologic malignancies.&#xD;
&#xD;
      The investigators have previously studied that conditioning regimen of i.v.&#xD;
      busulfan/melphalan/etoposide (BuME) was well tolerated and effective in patients with&#xD;
      relapsed or high risk NHL. And busulfan/cyclophosphamide/etoposide (BuCE) conditioning&#xD;
      regimen has been extensively utilized in ASCT for NHL.&#xD;
&#xD;
      Therefore, based on the encouraging results, the investigators will conduct a randomized&#xD;
      phase II multicenter trial of BuCE versus BuME as conditioning therapy for ASCT in patients&#xD;
      with NHL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2012</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 30, 2017</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>
    <intervention_model_description>Parallel assignment</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of progression free survival</measure>
    <time_frame>2 years</time_frame>
    <description>calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death Calculate from the date of ASCT (autologous stem cell transplantation) until the time of disease progression, relapse, or death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of overall survival</measure>
    <time_frame>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>6 months</time_frame>
    <description>calculate toxicities frequency</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Non-hodgkin Lymphoma</condition>
  <arm_group>
    <arm_group_label>busulfan cyclophosphamide etoposide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6, cyclophosphamide 50mg/kg/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>busulfan melphalan etoposide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6 melphalan 50mg/m2/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Busulfan</intervention_name>
    <description>busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6</description>
    <arm_group_label>busulfan cyclophosphamide etoposide</arm_group_label>
    <arm_group_label>busulfan melphalan etoposide</arm_group_label>
    <other_name>Busulfex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>cyclophosphamide 50mg/kg/day i.v. on days -3 and -2</description>
    <arm_group_label>busulfan cyclophosphamide etoposide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etoposide</intervention_name>
    <description>etoposide 400mg/m2 day i.v. on days -5 and -4</description>
    <arm_group_label>busulfan cyclophosphamide etoposide</arm_group_label>
    <arm_group_label>busulfan melphalan etoposide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melphalan</intervention_name>
    <description>melphalan 50mg/m2/day i.v. on days -3 and -2</description>
    <arm_group_label>busulfan melphalan etoposide</arm_group_label>
    <other_name>Alkeran</other_name>
  </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 or high risk NHL with remission&#xD;
             in induction chemotherapy&#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>Jong-Ho Won</name>
      <address>
        <city>Seoul</city>
        <zip>04401</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>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 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>
  <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>Cyclophosphamide</mesh_term>
    <mesh_term>Melphalan</mesh_term>
    <mesh_term>Busulfan</mesh_term>
    <mesh_term>Etoposide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03794167
org study id: CISL 12-05
nct id: NCT03794167
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators developed a protocol comparing busulfan/cyclophosphamide/etoposide (BuCE)
      and busulfan/melphalan/etoposide (BuME) regimen as a conditioning for high-dose therapy (HDT)
      in the patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).
Intravenous busulfan containing regimens as conditioning regimen have been used for both
      allogeneic and autologous stem cell transplantation in patients with hematologic and
      non-hematologic malignancies.

      The investigators have previously studied that conditioning regimen of i.v.
      busulfan/melphalan/etoposide (BuME) was well tolerated and effective in patients with
      relapsed or high risk NHL. And busulfan/cyclophosphamide/etoposide (BuCE) conditioning
      regimen has been extensively utilized in ASCT for NHL.

      Therefore, based on the encouraging results, the investigators will conduct a randomized
      phase II multicenter trial of BuCE versus BuME as conditioning therapy for ASCT in patients
      with NHL.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of progression free survival
time frame: 2 years
description: calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death Calculate from the date of ASCT (autologous stem cell transplantation) until the time of disease progression, relapse, or death
measure: Rate of overall survival
time frame: 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: 6 months
description: calculate toxicities frequency
arm group label: busulfan cyclophosphamide etoposide
arm group type: Experimental
description: busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6, cyclophosphamide 50mg/kg/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4
arm group label: busulfan melphalan etoposide
arm group type: Active Comparator
description: busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6 melphalan 50mg/m2/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4
intervention type: Drug
intervention name: Busulfan
description: busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6
arm group label: busulfan cyclophosphamide etoposide
arm group label: busulfan melphalan etoposide
other name: Busulfex
intervention type: Drug
intervention name: Cyclophosphamide
description: cyclophosphamide 50mg/kg/day i.v. on days -3 and -2
arm group label: busulfan cyclophosphamide etoposide
intervention type: Drug
intervention name: Etoposide
description: etoposide 400mg/m2 day i.v. on days -5 and -4
arm group label: busulfan cyclophosphamide etoposide
arm group label: busulfan melphalan etoposide
intervention type: Drug
intervention name: Melphalan
description: melphalan 50mg/m2/day i.v. on days -3 and -2
arm group label: busulfan melphalan etoposide
other name: Alkeran
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: Cyclophosphamide
mesh term: Melphalan
mesh term: Busulfan
mesh term: Etoposide
sharing ipd: No