<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/NCT01678417</url>
  </required_header>
  <id_info>
    <org_study_id>FL or MCL 131I-rituximab RIT</org_study_id>
    <nct_id>NCT01678417</nct_id>
  </id_info>
  <brief_title>131I-rituximab for Relapsed or Refractory Follicular or Mantle Cell Lymphoma</brief_title>
  <official_title>A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Follicular or Mantle 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>
      Follicular lymphoma (FL) and mantle cell lymphoma (MCL) are rare lymphomas which consist of&#xD;
      less than 5% of non-Hodgkin lymphoma in Korea. Although FL with histologic grade 1 or 2 has&#xD;
      relatively good prognosis, continual treatment is needed due to frequent relapse. FL with&#xD;
      histologic grade 3 has poor prognosis similar to that of diffuse large B cell lymphoma.&#xD;
      Meanwhile, the response rate to systemic chemotherapy in MCL is low, so the treatment of&#xD;
      relapsed MCL is challenging. So we investigate the efficacy of radioimmunotherapy using&#xD;
      131I-rituximab in refractory or relapsed patients with FL or MCL&#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 2017</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>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response duration</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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progression free survival</measure>
    <time_frame>up to 5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">29</enrollment>
  <condition>Relapsed or Refractory Follicular Lymphoma or Mantle 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 follicular lymphoma or mantle cell lymphoma&#xD;
&#xD;
          -  relapsed or refractory patients&#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&#xD;
             scan,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&#xD;
&#xD;
          -  heart 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>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 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>August 30, 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, Mantle-Cell</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/NCT01678417
org study id: FL or MCL 131I-rituximab RIT
nct id: NCT01678417
lead sponsor: 
has dmc: No
Follicular lymphoma (FL) and mantle cell lymphoma (MCL) are rare lymphomas which consist of
      less than 5% of non-Hodgkin lymphoma in Korea. Although FL with histologic grade 1 or 2 has
      relatively good prognosis, continual treatment is needed due to frequent relapse. FL with
      histologic grade 3 has poor prognosis similar to that of diffuse large B cell lymphoma.
      Meanwhile, the response rate to systemic chemotherapy in MCL is low, so the treatment of
      relapsed MCL is challenging. So we investigate the efficacy of radioimmunotherapy using
      131I-rituximab in refractory or relapsed patients with FL or MCL
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
measure: Response duration
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
measure: progression free survival
time frame: up to 5 years
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: 
country: Korea, Republic of
mesh term: Lymphoma
mesh term: Lymphoma, Mantle-Cell
mesh term: Rituximab