<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/NCT01686321</url>
  </required_header>
  <id_info>
    <org_study_id>DSHNHL-2010-1</org_study_id>
    <secondary_id>2010-024004-98</secondary_id>
    <nct_id>NCT01686321</nct_id>
  </id_info>
  <brief_title>Rituximab and Bendamustine in Very Elderly Patients or Elderly Medically Non Fit Patients With Aggressive B-cell Lymphoma</brief_title>
  <acronym>B-R-ENDA</acronym>
  <official_title>Subcutaneous Rituximab and Intravenous Bendamustine in Very Elderly Patients or Elderly Medically Non Fit Patients (&quot;Slow Go&quot;) With Aggressive CD20-positive B-cell</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Göttingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mundipharma Research GmbH &amp; Co KG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Göttingen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bendamustine is a well tolerable and very active agent in the treatment of Non Hodgkin's&#xD;
      lymphoma. However, in particular in aggressive B-cell lymphoma, only very few, small studies&#xD;
      have investigated the role of bendamustine in the treatment algorithm. The aim of the current&#xD;
      B-R-ENDA trial is to investigate efficacy and toxicity of the combination treatment of&#xD;
      bendamustine and subcutaneous rituximab in old patients or in elderly patients with high&#xD;
      comorbidity who do not qualify for a CHOP like treatment. The results of this study will form&#xD;
      the basis of a larger, prospective randomized phase III trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bendamustine is a well tolerable and very active agent in the treatment of Non Hodgkin's&#xD;
      lymphoma. However, in particular in aggressive B-cell lymphoma, only very few, small studies&#xD;
      have investigated the role of bendamustine in the treatment algorithm. The aim of the current&#xD;
      B-R-ENDA trial is to investigate efficacy and toxicity of the combination treatment of&#xD;
      bendamustine and subcutaneous rituximab in old patients or in elderly patients with high&#xD;
      comorbidity who do not qualify for a CHOP like treatment. The results of this study will form&#xD;
      the basis of a larger, prospective randomized phase III trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 4, 2012</start_date>
  <completion_date type="Actual">August 8, 2018</completion_date>
  <primary_completion_date type="Actual">August 8, 2018</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>Progression-free survival</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>adverse events (AE)'s</measure>
    <time_frame>up to 30 days after last study drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>serious adverse events (SAE)'s</measure>
    <time_frame>up to 30 days after last study drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>rate of therapy-associated deaths</measure>
    <time_frame>up to 30 days after last study drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>protocol adherence</measure>
    <time_frame>18 weeks after start of therapy</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>CR rate</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PR rate</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of primary progression</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>relapse rate</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>event-free survival</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>overall survival</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comprehensive Geriatric Assessment</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Aggressive Lymphoma</condition>
  <arm_group>
    <arm_group_label>Bendamustine and subcutaneous Rituximab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single-arm non randomized</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bendamustine and subcutaneous rituximab</intervention_name>
    <arm_group_label>Bendamustine and subcutaneous Rituximab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histology: Diagnosis of aggressive CD20+, confirmed by an excisional biopsy of a lymph&#xD;
             node or by a sufficiently extensive biopsy of an extranodal involvement if there is no&#xD;
             lymph node involvement. It will be possible to treat the following entities in this&#xD;
             study as defined by the new WHO classification of 2008: B-NHL, Follicular lymphoma&#xD;
             grade IIIb,DLBCL, not otherwise specified (NOS),common morphologic variants:&#xD;
             centroblastic,immunoblastic,anaplastic,rare morphologic variants.DLBCL&#xD;
             subtypes/entities:T cell/histiocyte rich large B-cell lymphoma, primary cutaneous&#xD;
             DLBCL, leg type, EBV-positive DLBCL of the elderly, DLBCL associated with chronic&#xD;
             inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large&#xD;
             B-cell lymphoma,ALK-positive large B-cell lymphoma, Plasmoblastic lymphoma, Primary&#xD;
             effusion lymphoma, B-cell lymphoma, unclassifiable, with features inter¬mediate&#xD;
             between diffuse large B-cell lymphoma and Burkitt lymphoma, B-cell lymphoma,&#xD;
             unclassifiable, with features inter¬mediate between diffuse large B-cell lymphoma and&#xD;
             Hodgkin lymphoma&#xD;
&#xD;
          -  Stage: Any stages according to Ann Arbor Classification&#xD;
&#xD;
          -  Risk group: All risk groups (IPI 1 to 5)&#xD;
&#xD;
          -  Life expectancy Life expectancy of at least 6 weeks, when lymphoma is treated&#xD;
&#xD;
          -  Age: Age elder than 81 or Age 61 to 80 and CIRS &gt;6 not qualifying for CHOP-therapy&#xD;
&#xD;
          -  Gender: any&#xD;
&#xD;
          -  Performance status: Performance status ECOG 0 - 3. The performance status of each&#xD;
             patient is to be assessed at the time of registration which might be after the&#xD;
             initiation of pre-phase treatment which, as experience has shown, can result in a&#xD;
             significant improvement of the patient´s performance status. A definition of the&#xD;
             performance status is provided in Appendix 25.6&#xD;
&#xD;
          -  Ability to give informed consent&#xD;
&#xD;
          -  Written informed consent of the patient&#xD;
&#xD;
          -  Contract of participation signed by the study center and sponsor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Already initiated lymphoma therapy (except for the prephase treatment until first&#xD;
             application of rituximab)&#xD;
&#xD;
          -  Serious accompanying disorder or impaired organ function (except when due to lymphoma&#xD;
             involvement), in particular: Heart: angina pectoris CCS &gt;2, cardiac failure NYHA &gt;3;&#xD;
             Lungs: the patient is to be excluded if the resultant pulmonary function test shows&#xD;
             FEV1&lt;50% or a diffusion capacity &lt;50% of the reference values: Calculated creatinin&#xD;
             clearance &lt; 10 ml/min (Cockcroft-Gault); Liver: total bilirubin &gt; 3 mg/dl;&#xD;
             Uncontrollable diabetes mellitus (because of prephase treatment with prednisone!)&#xD;
&#xD;
          -  Platelets &lt;100 000/mm3, leukocytes &lt;2500/mm3 (if not due to lymphoma)&#xD;
&#xD;
          -  Known hypersensitivity to the medications to be used&#xD;
&#xD;
          -  HIV-positivity&#xD;
&#xD;
          -  Acute or chronic active hepatitis&#xD;
&#xD;
          -  Poor patient compliance&#xD;
&#xD;
          -  Simultaneous participation in other treatment studies&#xD;
&#xD;
          -  Prior chemo- or radiotherapy, long-term use of corticosteroids or anti-neoplastic&#xD;
             drugs for previous disorder&#xD;
&#xD;
          -  Other concomitant tumor disease and/or tumor disease in the past 5 years (except&#xD;
             basalioma of the skin and carcinoma in situ)&#xD;
&#xD;
          -  CNS involvement of lymphoma (intracerebral, meningeal, intraspinal)&#xD;
&#xD;
          -  Active serious infections not controlled by oral or intravenous antibiotics or&#xD;
             anti-fungal&#xD;
&#xD;
          -  Any medical condition which in the opinion of the investigator places the subject at&#xD;
             an unacceptably high risk for toxicities.&#xD;
&#xD;
          -  Non-conformity to eligibility criteria.&#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>Lorenz Trümper, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University medicine Goettingen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prof. Trümper</name>
      <address>
        <city>Göttingen</city>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>December 27, 2018</last_update_submitted>
  <last_update_submitted_qc>December 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Göttingen</investigator_affiliation>
    <investigator_full_name>Lorenz, Trümper, MD</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>elderly patients</keyword>
  <keyword>bendamustine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Aggression</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</mesh_term>
    <mesh_term>Bendamustine Hydrochloride</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/NCT01686321
org study id: DSHNHL-2010-1
secondary id: 2010-024004-98
nct id: NCT01686321
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Bendamustine is a well tolerable and very active agent in the treatment of Non Hodgkin's
      lymphoma. However, in particular in aggressive B-cell lymphoma, only very few, small studies
      have investigated the role of bendamustine in the treatment algorithm. The aim of the current
      B-R-ENDA trial is to investigate efficacy and toxicity of the combination treatment of
      bendamustine and subcutaneous rituximab in old patients or in elderly patients with high
      comorbidity who do not qualify for a CHOP like treatment. The results of this study will form
      the basis of a larger, prospective randomized phase III trial.
Bendamustine is a well tolerable and very active agent in the treatment of Non Hodgkin's
      lymphoma. However, in particular in aggressive B-cell lymphoma, only very few, small studies
      have investigated the role of bendamustine in the treatment algorithm. The aim of the current
      B-R-ENDA trial is to investigate efficacy and toxicity of the combination treatment of
      bendamustine and subcutaneous rituximab in old patients or in elderly patients with high
      comorbidity who do not qualify for a CHOP like treatment. The results of this study will form
      the basis of a larger, prospective randomized phase III trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival
time frame: 2 years
measure: adverse events (AE)'s
time frame: up to 30 days after last study drug administration
measure: serious adverse events (SAE)'s
time frame: up to 30 days after last study drug administration
measure: rate of therapy-associated deaths
time frame: up to 30 days after last study drug administration
measure: protocol adherence
time frame: 18 weeks after start of therapy
measure: CR rate
time frame: 2 years
measure: PR rate
time frame: 2 years
measure: rate of primary progression
time frame: 2 years
measure: relapse rate
time frame: 2 years
measure: event-free survival
time frame: 2 years
measure: overall survival
time frame: 2 years
measure: Quality of life
time frame: 2 years
measure: Comprehensive Geriatric Assessment
time frame: 2 years
arm group label: Bendamustine and subcutaneous Rituximab
arm group type: Experimental
description: single-arm non randomized
intervention type: Drug
intervention name: Bendamustine and subcutaneous rituximab
arm group label: Bendamustine and subcutaneous Rituximab
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Lorenz Trümper, Prof
role: Principal Investigator
affiliation: University medicine Goettingen
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Göttingen
investigator full name: Lorenz, Trümper, MD
investigator title: Prof. Dr.
mesh term: Lymphoma
mesh term: Aggression
mesh term: Rituximab
mesh term: Bendamustine Hydrochloride