<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/NCT01670370</url>
  </required_header>
  <id_info>
    <org_study_id>JSPH-001</org_study_id>
    <nct_id>NCT01670370</nct_id>
  </id_info>
  <brief_title>Trial of R-GemOx Regimen in Previously Untreated Elderly Patients With DLBCL.</brief_title>
  <official_title>A Prospective, Single-arm, Open-label, Phase 2 Study to Evaluate Efficacy and Safety of R-GemOx Regimen as First-line Treatment in Elderly Patients With Diffuse Large B-cell Lymphoma (DLBCL).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate efficacy and safety of GemOx(Gemcitabine and&#xD;
      Oxaliplatin) combination with rituximab(R) as first-line treatment of elderly patients with&#xD;
      DLBCL&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies showed that the combination of rituximab, gemcitabine and oxaliplatin&#xD;
      (R-GemOx) achieved high efficacy with a low toxicity profile in relapsed and refractory&#xD;
      DLBCL. This regimen might be considered a putative treatment option for elderly patients. To&#xD;
      our knowledge, the efficacy and safety of R-GemOx when given as first-line therapy in elderly&#xD;
      patients with DLBCL remains unknown. The investigators therefore developed a two-weekly&#xD;
      regimen of rituximab combined with GemOx regimen as first line treatment in elderly DLBCL and&#xD;
      investigate its efficacy and safety.&#xD;
&#xD;
      Primary Outcome Measures:&#xD;
&#xD;
        -  overall response rate&#xD;
&#xD;
      Secondary Outcome Measures:&#xD;
&#xD;
        -  progression free survival&#xD;
&#xD;
        -  overall survival&#xD;
&#xD;
        -  safety and toxicity&#xD;
&#xD;
      Enrollment: 60 Study Start Date: August 2012 Primary Completion Date: Dec 2015&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2015</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>at the end of 3 cycles and 6 cycles of R-GemOx regimen(each cycle is 14 days)</time_frame>
    <description>overall response rate after 3 cycles and at the end of R-GemOx regimen.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>progression free survival</measure>
    <time_frame>Two-year</time_frame>
    <description>from date of inclusion to date of progression, relapse from response, or death from any cause or last follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>Two-year</time_frame>
    <description>from the date of inclusion to date of death, irrespective of cause or last follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence and severity of adverse events</measure>
    <time_frame>Up to 30 days following the last dose of study drug</time_frame>
    <description>All the treatment related adverse events was evaluated according to common terminology criteria adverse events(CTCAE) version 4.0</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Diffuse Large B-cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>Rituximab+Gemcitabine+oxaliplatin (R-GemOx)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rituximab: 375 mg/m2 IV day1, Gemcitabine 1g/m2 IV day 2, oxaliplatin 100mg/m2 IV day2(every 14 days)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>R-GemOx</intervention_name>
    <description>Rituximab Gemcitabine Oxaliplatin</description>
    <arm_group_label>Rituximab+Gemcitabine+oxaliplatin (R-GemOx)</arm_group_label>
    <other_name>Rituximab</other_name>
    <other_name>Gemcitabine</other_name>
    <other_name>Oxaliplatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Histologically confirmed CD20-positive DLBCL (The germinal center B-cell like (GCB) /&#xD;
             non-GCB subtype was determined by immunohistochemistry in paraffin-embedded tissue&#xD;
             using CD10, BCL6 and MUM1 protein markers based on Hans's algorithm);&#xD;
&#xD;
          2. New-diagnosed and untreated;&#xD;
&#xD;
          3. Age older than 70 years or older than 60 years with ECOG PS ≥2;&#xD;
&#xD;
          4. Understand and voluntarily sign an informed consent form, able to adhere to the study&#xD;
             visit schedule and other protocol requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Poor hepatic or renal function, defined as total serum bilirubin, transaminases or&#xD;
             creatinine over two times of the upper limit of normal concentration;&#xD;
&#xD;
          2. Poor cardiac function greater than Grade II according to New York Heart Association&#xD;
             Functional Classification;&#xD;
&#xD;
          3. Presence of Grade III nervous toxicity over two weeks;&#xD;
&#xD;
          4. Hepatitis B virus (HBV) load (HBV DNA) more than 1×105 copies/ml;&#xD;
&#xD;
          5. Concomitant malignancy other than DLBCL requiring treatment;&#xD;
&#xD;
          6. Concomitant with other hematologic diseases (such as leukemia, hemophilia, primary&#xD;
             myelofibrosis) which is unsuitable to be enrolled into this clinical trial;&#xD;
&#xD;
          7. Contraindication to any drug in this regimen;&#xD;
&#xD;
          8. Active and severe infectious diseases, such as severe pheumonia or septicaemia;&#xD;
&#xD;
          9. Major surgery within three weeks;&#xD;
&#xD;
         10. Any medical, psychological or social conditions which might interfere with the&#xD;
             investigators' assessment&#xD;
&#xD;
         11. In any conditions which investigator considered ineligible for this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>WEI XU, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <removed_countries>
    <country>China</country>
  </removed_countries>
  <reference>
    <citation>Lopez A, Gutierrez A, Palacios A, Blancas I, Navarrete M, Morey M, Perello A, Alarcon J, Martinez J, Rodriguez J. GEMOX-R regimen is a highly effective salvage regimen in patients with refractory/relapsing diffuse large-cell lymphoma: a phase II study. Eur J Haematol. 2008 Feb;80(2):127-32. doi: 10.1111/j.1600-0609.2007.00996.x. Epub 2007 Nov 20.</citation>
    <PMID>18005385</PMID>
  </reference>
  <reference>
    <citation>Meriggi F, Zaniboni A. Gemox: a widely useful therapy against solid tumors-review and personal experience. J Chemother. 2010 Oct;22(5):298-303. doi: 10.1179/joc.2010.22.5.298.</citation>
    <PMID>21123151</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital with Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>WEI XU</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Rituximab</keyword>
  <keyword>Gemcitabine</keyword>
  <keyword>Oxaliplatin</keyword>
  <keyword>Diffuse large B-cell lymphoma</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>Gemcitabine</mesh_term>
    <mesh_term>Oxaliplatin</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/NCT01670370
org study id: JSPH-001
nct id: NCT01670370
lead sponsor: 
has dmc: Yes
The purpose of this study is to investigate efficacy and safety of GemOx(Gemcitabine and
      Oxaliplatin) combination with rituximab(R) as first-line treatment of elderly patients with
      DLBCL
Previous studies showed that the combination of rituximab, gemcitabine and oxaliplatin
      (R-GemOx) achieved high efficacy with a low toxicity profile in relapsed and refractory
      DLBCL. This regimen might be considered a putative treatment option for elderly patients. To
      our knowledge, the efficacy and safety of R-GemOx when given as first-line therapy in elderly
      patients with DLBCL remains unknown. The investigators therefore developed a two-weekly
      regimen of rituximab combined with GemOx regimen as first line treatment in elderly DLBCL and
      investigate its efficacy and safety.

      Primary Outcome Measures:

        -  overall response rate

      Secondary Outcome Measures:

        -  progression free survival

        -  overall survival

        -  safety and toxicity

      Enrollment: 60 Study Start Date: August 2012 Primary Completion Date: Dec 2015
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: overall response rate
time frame: at the end of 3 cycles and 6 cycles of R-GemOx regimen(each cycle is 14 days)
description: overall response rate after 3 cycles and at the end of R-GemOx regimen.
measure: progression free survival
time frame: Two-year
description: from date of inclusion to date of progression, relapse from response, or death from any cause or last follow-up.
measure: overall survival
time frame: Two-year
description: from the date of inclusion to date of death, irrespective of cause or last follow-up.
measure: The incidence and severity of adverse events
time frame: Up to 30 days following the last dose of study drug
description: All the treatment related adverse events was evaluated according to common terminology criteria adverse events(CTCAE) version 4.0
arm group label: Rituximab+Gemcitabine+oxaliplatin (R-GemOx)
arm group type: Experimental
description: Rituximab: 375 mg/m2 IV day1, Gemcitabine 1g/m2 IV day 2, oxaliplatin 100mg/m2 IV day2(every 14 days)
intervention type: Drug
intervention name: R-GemOx
description: Rituximab Gemcitabine Oxaliplatin
arm group label: Rituximab+Gemcitabine+oxaliplatin (R-GemOx)
other name: Rituximab
other name: Gemcitabine
other name: Oxaliplatin
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: WEI XU, M.D., Ph.D.
role: Principal Investigator
affiliation: The First Affiliated Hospital with Nanjing Medical University
country: China
citation: Lopez A, Gutierrez A, Palacios A, Blancas I, Navarrete M, Morey M, Perello A, Alarcon J, Martinez J, Rodriguez J. GEMOX-R regimen is a highly effective salvage regimen in patients with refractory/relapsing diffuse large-cell lymphoma: a phase II study. Eur J Haematol. 2008 Feb;80(2):127-32. doi: 10.1111/j.1600-0609.2007.00996.x. Epub 2007 Nov 20.
PMID: 18005385
citation: Meriggi F, Zaniboni A. Gemox: a widely useful therapy against solid tumors-review and personal experience. J Chemother. 2010 Oct;22(5):298-303. doi: 10.1179/joc.2010.22.5.298.
PMID: 21123151
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital with Nanjing Medical University
investigator full name: WEI XU
investigator title: Professor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Gemcitabine
mesh term: Oxaliplatin