<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/NCT02993536</url>
  </required_header>
  <id_info>
    <org_study_id>UPCC 30415</org_study_id>
    <nct_id>NCT02993536</nct_id>
  </id_info>
  <brief_title>Clonal Evolution of B Cells in High-risk CLL After Idelalisib-rituximab</brief_title>
  <official_title>Clonal Evolution of B Cells in High-risk Chronic Lymphocytic Leukemia Patients After Idelalisib-rituximab Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abramson Cancer Center at Penn Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abramson Cancer Center at Penn Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to assess the evolution of B cells at a genetic and&#xD;
      surface-marker level in high-risk CLL after idelalisib-rituximab treatment. The targeted&#xD;
      population includes 20 subjects ages 18 or older diagnosed with high-risk CLL. This will&#xD;
      include patients with relapsed or refractory disease who require therapy with idelalisib and&#xD;
      rituximab as per FDA label. This is an observational study for peripheral blood samples of&#xD;
      these patients collected at pre-determined time points.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Low likelihood to usedrug in clinic practice based on emergining AE profile and data from front&#xD;
    line clinical trials&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 2015</start_date>
  <primary_completion_date type="Anticipated">November 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of somatic hypermutation</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Lymphocytic Leukemia</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with relapsed or refractory CLL requiring treatment and receiving&#xD;
        idelalisib-rituximab&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
          -  Ability to provide peripheral blood samples&#xD;
&#xD;
          -  Diagnosis of CLL&#xD;
&#xD;
          -  Indication(s) for CLL therapy&#xD;
&#xD;
          -  At least one criterion for high-risk disease&#xD;
&#xD;
               -  Disease refractory (e.g., no response) to at least one round of chemotherapy&#xD;
&#xD;
               -  Disease that has relapsed (i.e., returned) after at least one round of&#xD;
                  chemotherapy&#xD;
&#xD;
               -  Proven presence of the 17p deletion within CLL cells&#xD;
&#xD;
          -  Planned receipt of idelalisib-rituximab as per FDA guidelines and patient's&#xD;
             oncologists&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not meet the diagnostic criteria for CLL or at least one indication&#xD;
             for treatment.&#xD;
&#xD;
          -  Patients who are receiving idelalisib with an off-label indication&#xD;
&#xD;
          -  Patients who do not or cannot provide informed consent to donate peripheral blood&#xD;
             tumor samples to our stem cell core facility&#xD;
&#xD;
          -  Patients who do not provide informed consent to collect clinical, prognostic, and&#xD;
             outcomes data during the time period that they are treated with idelalisib-rituximab&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony Mato, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Abramson Cancer Center at Penn Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Abramson Cancer Center of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>April 12, 2019</last_update_submitted>
  <last_update_submitted_qc>April 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leukemia</mesh_term>
    <mesh_term>Leukemia, Lymphoid</mesh_term>
    <mesh_term>Leukemia, Lymphocytic, Chronic, B-Cell</mesh_term>
  </condition_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/NCT02993536
org study id: UPCC 30415
nct id: NCT02993536
lead sponsor: 
has dmc: Yes
The purpose of the study is to assess the evolution of B cells at a genetic and
      surface-marker level in high-risk CLL after idelalisib-rituximab treatment. The targeted
      population includes 20 subjects ages 18 or older diagnosed with high-risk CLL. This will
      include patients with relapsed or refractory disease who require therapy with idelalisib and
      rituximab as per FDA label. This is an observational study for peripheral blood samples of
      these patients collected at pre-determined time points.
observational model: Cohort
time perspective: Prospective
measure: Number of somatic hypermutation
time frame: 12 months
intervention type: Other
intervention name: Biospecimen Collection
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anthony Mato, MD
role: Principal Investigator
affiliation: Abramson Cancer Center at Penn Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Leukemia
mesh term: Leukemia, Lymphoid
mesh term: Leukemia, Lymphocytic, Chronic, B-Cell