<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/NCT01676558</url>
  </required_header>
  <id_info>
    <org_study_id>DLBCL_131I-rituximab RIT</org_study_id>
    <nct_id>NCT01676558</nct_id>
  </id_info>
  <brief_title>A Phase II Study of 131I-rituximab for Relapsed/Refractory Diffuse Large B Cell Lymphoma (DLBCL)</brief_title>
  <official_title>A Phase II Study of 131I-rituximab for Elderly or Poor Performance Status Patients With Diffuse Large B Cell Lymphoma (DLBCL) or for Adult Patients With Relapsed or Refractory DLBCL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Korea Cancer Center Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Korea Cancer Center Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma in&#xD;
      Korea. Although there is standard therapy, which is called 'R-CHOP', many obstacles to use&#xD;
      aggressive cytotoxic chemotherapeutic agents such as old age, poor performance status,&#xD;
      refractoriness, and relapsed disease still remains. So we investigate the efficacy of&#xD;
      radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with DLBCL.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2016</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>overall response rate</measure>
    <time_frame>up to 5 years</time_frame>
    <description>International Working Group Response criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response duration</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progression free survival</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Adverse event</measure>
    <time_frame>up to 5 years</time_frame>
    <description>grading the adverse events using CTCAE version 4.03</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Relapsed or Refractory Diffuse Large B Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>131I-rituximab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>131I-rituximab</intervention_name>
    <arm_group_label>131I-rituximab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed diffuse large B cell lymphoma Elderly (&gt;65 years) or&#xD;
             medically ineligible to standard cytotoxic chemotherapy due to poor performance&#xD;
             status, or relapsed or refractory patients Eastern Cooperative Oncology Group&#xD;
             performance status ≤ 2, age≥ 20 years Relapsed or refractory after autologous&#xD;
             hematopoietic stem cell transplantation (auto-HSCT) in young patients with good&#xD;
             performance status and indicated to high dose chemotherapy and auto-HSCT More than one&#xD;
             measurable lesion&#xD;
&#xD;
          -  More than 2cm sized lesion in conventional CT scan,&#xD;
&#xD;
          -  More than 1cm sized lesion in spiral CT or contrast-enhanced PET/CT Adequate renal&#xD;
             function (serum creatinine ≤ 2.0 mg/dl or Ccr ≥ 60 ml/min) Adequate hepatic function&#xD;
             (serum bilirubin ≤ 2.0 mg/dl , AST/ALT ≤ 3 upper normal limit) Adequate bone marrow&#xD;
             reservoir (ANC ≥1,500/㎕, platelet count≥ 75,000/㎕) patient who agree the purpose and&#xD;
             intention of this clinical trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  recent (&lt;5 years) history of other malignancy or unrecovered from the disease&#xD;
             (appropriately treated skin cancer and uterine cervix carcinoma in situ are excluded)&#xD;
&#xD;
               -  hemodynamically unstable due to the recent (&lt;12 months) history of severe heart&#xD;
                  disease such as myocardial infarction&#xD;
&#xD;
               -  acute complications of severe lung or metabolic disease&#xD;
&#xD;
               -  Combined severe neurological or psychiatric disease Unrecovered from infection or&#xD;
                  other medical disease Recent (&lt;30 days) history of enrollment of other clinical&#xD;
                  trial Pregnant or breast-feeding woman women of childbearing potential and men&#xD;
                  not employing adequate contraception at least for 1 year Previous history drug&#xD;
                  allergy to the content of 131I-rituximab Infection(sepsis, pneumonia, viral&#xD;
                  infection, etc) (inactivated hepatitis B carrier can be enrolled) Young patient&#xD;
                  with good performance status indicated to autologous hematopoietic stem cell&#xD;
                  transplantation irrespective of the failure of 1st line chemotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hye Jin Kang, M.D.</last_name>
    <phone>+82-2-970-1289</phone>
    <email>mdhyejin@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dong-Yeop Shin, M.D.</last_name>
    <phone>+82-2-970-1246</phone>
    <email>baramg@hanmail.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences</name>
      <address>
        <city>Seoul</city>
        <zip>139-706</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hye Jin Kang, M.D.</last_name>
    </contact>
    <contact_backup>
      <last_name>Dong-Yeop Shin, M.D.</last_name>
    </contact_backup>
    <investigator>
      <last_name>Hye Jin Kang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Dong-Yeop Shin, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sung Hyun Yang, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Im Il Na, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hyo-Rak Lee, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sang Moo Lim, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chang Woon Choi, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Byung Il Kim, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ilhan Im, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Seung Sook Lee, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>November 13, 2012</last_update_submitted>
  <last_update_submitted_qc>November 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2012</last_update_posted>
  <keyword>diffuse large B cell lymphoma</keyword>
  <keyword>radioimmunotherapy</keyword>
  <keyword>131I-rituximab</keyword>
  <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>Rituximab</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/NCT01676558
org study id: DLBCL_131I-rituximab RIT
nct id: NCT01676558
lead sponsor: 
has dmc: No
Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma in
      Korea. Although there is standard therapy, which is called 'R-CHOP', many obstacles to use
      aggressive cytotoxic chemotherapeutic agents such as old age, poor performance status,
      refractoriness, and relapsed disease still remains. So we investigate the efficacy of
      radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with DLBCL.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: overall response rate
time frame: up to 5 years
description: International Working Group Response criteria
measure: Response duration
time frame: up to 5 years
measure: progression free survival
time frame: up to 5 years
measure: Overall survival
time frame: up to 5 years
measure: Number of Adverse event
time frame: up to 5 years
description: grading the adverse events using CTCAE version 4.03
arm group label: 131I-rituximab
arm group type: Experimental
description: 131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles
intervention type: Drug
intervention name: 131I-rituximab
arm group label: 131I-rituximab
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Hye Jin Kang, M.D.
phone: +82-2-970-1289
email: mdhyejin@gmail.com
last name: Dong-Yeop Shin, M.D.
phone: +82-2-970-1246
email: baramg@hanmail.net
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Korea, Republic of
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Rituximab