<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/NCT02992223</url>
  </required_header>
  <id_info>
    <org_study_id>Oss_Z-BEAM</org_study_id>
    <nct_id>NCT02992223</nct_id>
  </id_info>
  <brief_title>Retrospective Analysis on Relapsed/Refractory Aggressive Non Hodgkin Lymphoma Treated With Z-BEAM Plus ASCT</brief_title>
  <official_title>Retrospective Collection of Data on Patient With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma Treated With Y90 Ibritumomab Tiuxetan Radioimmunotherapy Plus High-Dose Chemotherapy and Autologous Stem Cell Transplant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera Città della Salute e della Scienza di Torino</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Ospedaliera Città della Salute e della Scienza di Torino</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate if Y90 Ibritumomab Tiuxetan Radioimmunotherapy in addition to standard high dose&#xD;
      chemotherapy followed by autologous stem cell transplant could improve prognosis in patients&#xD;
      affected by relapsed/refractory aggressive non Hodgkin lymphoma&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Date of last follow-up for at least 18 months (up to 78 months)</time_frame>
    <description>Time to last follow-up or death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>From first response to last follow-up for at least 18 month (up to 78 months)</time_frame>
    <description>Time from last response to nearest relapse or follow-up</description>
  </primary_outcome>
  <enrollment type="Actual">58</enrollment>
  <condition>Refractory B-Cell Non-Hodgkin Lymphoma</condition>
  <condition>Recurrent B-Cell Non-Hodgkin Lymphoma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma treated with Y90&#xD;
        Ibritumomab Tiuxetan Radioimmunotherapy Plus High-Dose Chemotherapy and Autologous Stem&#xD;
        Cell Transplant&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  High Risk Relapsed/refractory aggressive non-hodgkin lymphoma defined as:&#xD;
&#xD;
          -  Progressive disease&#xD;
&#xD;
          -  Early relapse (within 12 months from response)&#xD;
&#xD;
          -  Recurrent relapse&#xD;
&#xD;
          -  Treated with salvage chemotherapy followed by Y90 Ibritumomab Tiuxetan plus high-dose&#xD;
             chemotherapy and Autologous stem cell transplant&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Previous treatment with Rituximab&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with no complete data available for collection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbara Botto, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AOU Città della Salute e della Scienza di Torino</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 12, 2016</last_update_submitted>
  <last_update_submitted_qc>December 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera Città della Salute e della Scienza di Torino</investigator_affiliation>
    <investigator_full_name>Barbara Botto</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Aggressive B-cell non-Hodgkin Lymphoma</keyword>
  <keyword>Relapsed</keyword>
  <keyword>Refractory</keyword>
  <keyword>Zevalin</keyword>
  <keyword>Y90 Ibritumomab Tiuxetan</keyword>
  <keyword>Autologous stem cell transplant</keyword>
  <keyword>BEAM</keyword>
  <keyword>Recurrent</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>
    <mesh_term>Lymphoma, B-Cell</mesh_term>
    <mesh_term>Aggression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>paper publication</ipd_description>
  </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/NCT02992223
org study id: Oss_Z-BEAM
nct id: NCT02992223
lead sponsor: 
has dmc: No
Evaluate if Y90 Ibritumomab Tiuxetan Radioimmunotherapy in addition to standard high dose
      chemotherapy followed by autologous stem cell transplant could improve prognosis in patients
      affected by relapsed/refractory aggressive non Hodgkin lymphoma
observational model: Cohort
time perspective: Retrospective
measure: Overall Survival
time frame: Date of last follow-up for at least 18 months (up to 78 months)
description: Time to last follow-up or death
measure: Progression Free Survival
time frame: From first response to last follow-up for at least 18 month (up to 78 months)
description: Time from last response to nearest relapse or follow-up
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Barbara Botto, MD
role: Principal Investigator
affiliation: AOU Città della Salute e della Scienza di Torino
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliera Città della Salute e della Scienza di Torino
investigator full name: Barbara Botto
investigator title: MD
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Lymphoma, B-Cell
mesh term: Aggression
sharing ipd: Yes
ipd description: paper publication