<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/NCT01678404</url>
  </required_header>
  <id_info>
    <org_study_id>MZL 131I-rituximab RIT</org_study_id>
    <nct_id>NCT01678404</nct_id>
  </id_info>
  <brief_title>131I-rituximab for Relapsed or Refractory Marginal Zone B-cell Lymphoma</brief_title>
  <official_title>A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma</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>
      Marginal zone B-cell lymphoma (MZL) is a lymphoma originated from B-cell in lymph node with&#xD;
      variable differentiation status, which is distributed to a variety of organs.&#xD;
&#xD;
      A high response rate and long term survival is possible through surgery or radiation therapy&#xD;
      alone in the case of limited disease. However frequent relapse and progression is observed&#xD;
      despite of long term survival. The treatment after relapse has not been established yet.&#xD;
&#xD;
      So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or&#xD;
      relapsed patients with MZL.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2011</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">September 2014</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 Events</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">28</enrollment>
  <condition>Relapsed or Refractory Marginal Zone 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 marginal zone B-cell lymphoma&#xD;
&#xD;
          -  relapsed or refractory patients after treatment including chemotherapy, radiation&#xD;
             therapy, and surgery&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status ≤ 2&#xD;
&#xD;
          -  age≥ 20 years&#xD;
&#xD;
          -  More than one measurable lesion (More than 2cm sized lesion in conventional CT scan,&#xD;
             More than 1cm sized lesion in spiral CT or contrast-enhanced PET/CT )&#xD;
&#xD;
          -  Adequate renal function (serum creatinine ≤ 2.0 mg/dl or Ccr ≥ 60 ml/min)&#xD;
&#xD;
          -  Adequate hepatic function (serum bilirubin ≤ 2.0 mg/dl , AST/ALT ≤ 3 upper normal&#xD;
             limit)&#xD;
&#xD;
          -  Adequate bone marrow reservoir (ANC ≥1,500/㎕, platelet count≥ 75,000/㎕)&#xD;
&#xD;
          -  patient who agree the purpose and 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&#xD;
&#xD;
          -  Unrecovered from infection or other medical disease&#xD;
&#xD;
          -  Recent (&lt;30 days) history of enrollment of other clinical trial&#xD;
&#xD;
          -  Pregnant or breast-feeding woman&#xD;
&#xD;
          -  women of childbearing potential and men not employing adequate contraception at least&#xD;
             for 1 year&#xD;
&#xD;
          -  Previous history drug allergy to the content of 131I-rituximab&#xD;
&#xD;
          -  Infection(sepsis, pneumonia, viral infection, etc) (inactivated hepatitis B carrier&#xD;
             can be enrolled)&#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_official>
    <last_name>Hye Jin Kang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences</affiliation>
  </overall_official>
  <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>
    <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>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>Dong-Yeop Shin, 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>Change 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 Lim, 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>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>September 4, 2012</last_update_submitted>
  <last_update_submitted_qc>September 4, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2012</last_update_posted>
  <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, B-Cell, Marginal Zone</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/NCT01678404
org study id: MZL 131I-rituximab RIT
nct id: NCT01678404
lead sponsor: 
has dmc: No
Marginal zone B-cell lymphoma (MZL) is a lymphoma originated from B-cell in lymph node with
      variable differentiation status, which is distributed to a variety of organs.

      A high response rate and long term survival is possible through surgery or radiation therapy
      alone in the case of limited disease. However frequent relapse and progression is observed
      despite of long term survival. The treatment after relapse has not been established yet.

      So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or
      relapsed patients with MZL.
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 Events
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.
role: Principal Investigator
affiliation: Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
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
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, B-Cell, Marginal Zone
mesh term: Rituximab