<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/NCT03297697</url>
  </required_header>
  <id_info>
    <org_study_id>201706050</org_study_id>
    <secondary_id>5K12CA167540-07</secondary_id>
    <nct_id>NCT03297697</nct_id>
  </id_info>
  <brief_title>Minimal Residual Disease in Peripheral T-cell Lymphoma</brief_title>
  <official_title>A Multi-Institutional Prospective Cohort Study of Minimal Residual Disease in Peripheral T-cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Invivoscribe, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>T-Cell Leukemia Lymphoma Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      As T-cell receptor sequencing by LymphoTrack is an assay with high sensitivity that can be&#xD;
      performed in peripheral blood, the investigators wish to evaluate the ability of this assay&#xD;
      to predict which patients are at higher risk of relapse after initial therapy for peripheral&#xD;
      T-cell lymphomas which is being given for curative intent. Additionally, as more is known&#xD;
      about the ability of dynamic monitoring of cfDNA in B-cell lymphomas to predict relapse, the&#xD;
      investigators wish to explore the use of this technology in T-cell lymphomas.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Anticipated">December 7, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 7, 2024</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>Feasibility of LymphoTrack TCR clonality assay of evaluating minimal residual disease as measured by progression-free survival (PFS) at the completion of 2 years</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of LymphoTrack TCR clonality assay of evaluating minimal residual disease as measured by the ability of Lymphotrack to detect minimal residual disease in at least 60% of baseline samples</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate whether LymphoTrack TCR clonality assay can distinguish participants with peripheral T-cell lymphomas (PTCL) who are at risk of relapse</measure>
    <time_frame>Through 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants with a dominant tumor sequence identified from the pre-treatment test specimen</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine whether monitoring for the tumor-specific clone at minimal residual disease (MRD) level predicts response to treatment</measure>
    <time_frame>Through 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of decline of the tumor specific sequence or sequences predict duration of response</measure>
    <time_frame>Through 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characterize the lead time from MRD positivity to subsequent clinical relapse</measure>
    <time_frame>Through 2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">44</enrollment>
  <condition>Peripheral T Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>Arm 1: Lymphotrack</arm_group_label>
    <description>-Patients will be treated with frontline chemotherapy per the treating physician's discretion. Collection of the pre-treatment tumor biopsy to identify the tumor-specific clonotype and peripheral blood samples at various time points for assessment of minimal residual disease using the LymphoTrack MRD assay. The results of these studies will be performed in batches and therefore will not be available to patients and clinicians to make clinical decisions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tumor biopsy</intervention_name>
    <description>Biopsy specimen can be from bone marrow, blood, or lymph node. This specimen should have a high disease load</description>
    <arm_group_label>Arm 1: Lymphotrack</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Peripheral blood draw</intervention_name>
    <description>-Baseline, C1D1, C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, end of treatment, 3 month follow-up (optional), 6 month follow-up, 9 month follow-up (optional), 12 month follow-up, 15 month follow-up (optional), 18 month follow-up, 21 month follow-up (optional), 24 month follow-up, and at relapse</description>
    <arm_group_label>Arm 1: Lymphotrack</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lymphotrack TCR clonality assay</intervention_name>
    <description>-Assay with high sensitivity that can be performed with peripheral blood</description>
    <arm_group_label>Arm 1: Lymphotrack</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, bone marrow, and tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with peripheral T cell lymphoma who are seen in clinics associated with the&#xD;
        participating locations&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age.&#xD;
&#xD;
          -  Histologically-confirmed peripheral T-cell lymphoma being treated with curative&#xD;
             intent. Eligible histologies include, but are not limited to: peripheral T-cell&#xD;
             lymphoma, not otherwise specified; angioimmunoblastic T-cell lymphoma; anaplastic&#xD;
             large cell lymphoma, ALK negative; and anaplastic large cell lymphoma, ALK positive.&#xD;
&#xD;
          -  Plan for treatment with frontline multi-agent anthracycline containing chemotherapy&#xD;
             for curative intent (for example, CHOP, CHOEP, EPOCH). A frontline therapy program can&#xD;
             include different sequential phases of treatment, including high-dose therapy and&#xD;
             autologous stem cell transplantation.&#xD;
&#xD;
          -  Availability of pre-treatment test specimen from bone marrow, blood, lymph node, or&#xD;
             alternate site to identify tumor-specific clonotype, or willingness to undergo biopsy&#xD;
             if sufficient tissue is not available at time of enrollment (e.g. 15 slides from fixed&#xD;
             formalin-fixed paraffin embedded tumor tissue&#xD;
&#xD;
             *Patients who have less than 15 slides of fixed formalin-fixed paraffin embedded tumor&#xD;
             tissue may be considered for enrollment after discussion with the study principal&#xD;
             investigator&#xD;
&#xD;
          -  Able to understand and willing to sign an IRB approved written informed consent&#xD;
             document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Receiving second line of therapy or greater.&#xD;
&#xD;
          -  Diagnosis of primary cutaneous T-cell lymphoma, extranodal NK-cell lymphoma, acute&#xD;
             T-cell lymphoma/leukemia, hepatosplenic T-cell lymphoma.&#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>Neha Mehta-Shah, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>December 19, 2022</last_update_submitted>
  <last_update_submitted_qc>December 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</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>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
    <mesh_term>Neoplasm, Residual</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03297697
org study id: 201706050
secondary id: 5K12CA167540-07
nct id: NCT03297697
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
As T-cell receptor sequencing by LymphoTrack is an assay with high sensitivity that can be
      performed in peripheral blood, the investigators wish to evaluate the ability of this assay
      to predict which patients are at higher risk of relapse after initial therapy for peripheral
      T-cell lymphomas which is being given for curative intent. Additionally, as more is known
      about the ability of dynamic monitoring of cfDNA in B-cell lymphomas to predict relapse, the
      investigators wish to explore the use of this technology in T-cell lymphomas.
observational model: Cohort
time perspective: Prospective
measure: Feasibility of LymphoTrack TCR clonality assay of evaluating minimal residual disease as measured by progression-free survival (PFS) at the completion of 2 years
time frame: 2 years
measure: Feasibility of LymphoTrack TCR clonality assay of evaluating minimal residual disease as measured by the ability of Lymphotrack to detect minimal residual disease in at least 60% of baseline samples
time frame: Baseline
measure: Evaluate whether LymphoTrack TCR clonality assay can distinguish participants with peripheral T-cell lymphomas (PTCL) who are at risk of relapse
time frame: Through 2 years
measure: Percentage of participants with a dominant tumor sequence identified from the pre-treatment test specimen
time frame: Baseline
measure: Determine whether monitoring for the tumor-specific clone at minimal residual disease (MRD) level predicts response to treatment
time frame: Through 2 years
measure: Rate of decline of the tumor specific sequence or sequences predict duration of response
time frame: Through 2 years
measure: Characterize the lead time from MRD positivity to subsequent clinical relapse
time frame: Through 2 years
arm group label: Arm 1: Lymphotrack
description: -Patients will be treated with frontline chemotherapy per the treating physician's discretion. Collection of the pre-treatment tumor biopsy to identify the tumor-specific clonotype and peripheral blood samples at various time points for assessment of minimal residual disease using the LymphoTrack MRD assay. The results of these studies will be performed in batches and therefore will not be available to patients and clinicians to make clinical decisions.
intervention type: Procedure
intervention name: Tumor biopsy
description: Biopsy specimen can be from bone marrow, blood, or lymph node. This specimen should have a high disease load
arm group label: Arm 1: Lymphotrack
intervention type: Procedure
intervention name: Peripheral blood draw
description: -Baseline, C1D1, C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, end of treatment, 3 month follow-up (optional), 6 month follow-up, 9 month follow-up (optional), 12 month follow-up, 15 month follow-up (optional), 18 month follow-up, 21 month follow-up (optional), 24 month follow-up, and at relapse
arm group label: Arm 1: Lymphotrack
intervention type: Procedure
intervention name: Lymphotrack TCR clonality assay
description: -Assay with high sensitivity that can be performed with peripheral blood
arm group label: Arm 1: Lymphotrack
Blood, bone marrow, and tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Neha Mehta-Shah, M.D.
role: Study Chair
affiliation: Washington University School of Medicine
facility: 
facility: 
facility: 
country: United States
url: http://www.siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Neoplasm, Residual
sharing ipd: No