<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/NCT04503538</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00067341</org_study_id>
    <secondary_id>WFBCCC 99520</secondary_id>
    <nct_id>NCT04503538</nct_id>
  </id_info>
  <brief_title>Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity</brief_title>
  <official_title>Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity Following CAR-T Infusion on an Outpatient Basis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to replace one of participants' outpatient chimeric antigen&#xD;
      receptor T-cell (CAR-T) therapy follow up visits with a virtual or &quot;telemedicine&quot; visit. The&#xD;
      telemedicine visit will use an electronic tablet with a camera and a microphone that allows&#xD;
      participants to communicate with their physicians and nurses. Participants will be provided&#xD;
      with the necessary equipment to complete these visits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective: To determine feasibility of telemedicine for outpatient cytokine release&#xD;
      syndrome and neurotoxicity assessment (how many telemedicine visits successfully completed&#xD;
      per patient)&#xD;
&#xD;
      Secondary Objective(s)&#xD;
&#xD;
        -  To determine how many times a telemedicine visit triggered an action (inpatient&#xD;
           admission/ outpatient observation status)&#xD;
&#xD;
        -  To determine how many patients were detected to have cytokine release syndrome and/or&#xD;
           neurotoxicity based on their telemedicine visit&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Principal investigator decided not to pursue trial&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 2020</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Successfully Completed Telemedicine Visits</measure>
    <time_frame>3 years</time_frame>
    <description>To determine feasibility of telemedicine for outpatient cytokine release syndrome and neurotoxicity assessment. Investigators will consider telemedicine feasible in this population if at least 13 of the 15 patients successfully complete 80% of telemedicine visits. A visit will be considered successful if all measurements are recorded OR if the visit is interrupted because the participant needs to come into the CAR-T unit for assessment. If a patient is admitted, then the 80% benchmark will be calculated based on the number of days the patient was outpatient at 11 pm. The proportion meeting the 80% benchmark will be reported along with an exact 95% confidence interval.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Times a Telemedicine Visit Triggered Action</measure>
    <time_frame>3 years</time_frame>
    <description>To determine how many times a telemedicine visit triggered an inpatient admission or outpatient observation status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients to Have Cytokine Release Syndrome</measure>
    <time_frame>3 years</time_frame>
    <description>Descriptive statistics will be used to characterize the number of cases of cytokine release syndrome based on telemedicine visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients to Have Neurotoxicity</measure>
    <time_frame>3 years</time_frame>
    <description>Descriptive statistics will be used to characterize the number neurotoxicities reported based on telemedicine visits.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Large B-cell Lymphoma</condition>
  <condition>Diffuse Large B Cell Lymphoma</condition>
  <condition>Primary Mediastinal Large B Cell Lymphoma</condition>
  <condition>High-grade B-cell Lymphoma</condition>
  <condition>Follicular Lymphoma</condition>
  <arm_group>
    <arm_group_label>CAR-T cell therapy and Telemedicine</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All outpatient CAR-T patients will require assessments for cytokine release syndrome and neurotoxicity three times daily (every 8 hours)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telemedicine visit</intervention_name>
    <description>Participants will be provided with a Wifi-and cellular enabled electronic tablet. Additionally, participants will receive a kit that contains a thermometer, a blood pressure monitoring cuff, and a pulse oximeter (to measure oxygen saturation level). Participants will attend an educational session to learn how the telemedicine visit works. Caregivers should attend with participants and will be trained to take temperatures, blood pressures, and oxygen saturation levels. Participants will also be asked to complete a test telehealth visit.</description>
    <arm_group_label>CAR-T cell therapy and Telemedicine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must have histologically confirmed relapsed or refractory large B-cell&#xD;
             lymphoma after two or more lines of systemic therapy, including diffuse large B-cell&#xD;
             lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma,&#xD;
             high grade B-cell lymphoma, and DLBCL arising from of follicular lymphoma&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  ECOG or Karnofsky performance status of ≤ 2&#xD;
&#xD;
          -  Patients must have a caregiver(s) with them 24 hours a day for the first 30 days after&#xD;
             CAR-T cell infusion&#xD;
&#xD;
          -  Patients must stay within a 30-minute distance from the cancer center&#xD;
&#xD;
          -  Patients must have access to wifi network or a cellular network&#xD;
&#xD;
          -  Patients and caregiver(s) participating in patient's care must attend the education&#xD;
             session for outpatient CAR-T and demonstrate competency to collect vital signs with&#xD;
             equipment provided&#xD;
&#xD;
          -  Must have the ability to understand and the willingness to sign an IRB-approved&#xD;
             informed consent document (either directly or via a legally authorized&#xD;
             representative).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have acute lymphoblastic leukemia/lymphoma&#xD;
&#xD;
          -  Patients who have a high tumor burden (&gt; 10 cm largest mass) have a high risk of CRS&#xD;
             who will receive CAR-T as an inpatient&#xD;
&#xD;
          -  Patient or caregiver unable to understand and follow English language&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements.&#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>Rakhee Vaidya, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>October 21, 2020</last_update_submitted>
  <last_update_submitted_qc>October 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Relapsed large B-cell lymphoma</keyword>
  <keyword>Refractory 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>
    <mesh_term>Cytokine Release Syndrome</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/NCT04503538
org study id: IRB00067341
secondary id: WFBCCC 99520
nct id: NCT04503538
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this research is to replace one of participants' outpatient chimeric antigen
      receptor T-cell (CAR-T) therapy follow up visits with a virtual or "telemedicine" visit. The
      telemedicine visit will use an electronic tablet with a camera and a microphone that allows
      participants to communicate with their physicians and nurses. Participants will be provided
      with the necessary equipment to complete these visits.
Primary Objective: To determine feasibility of telemedicine for outpatient cytokine release
      syndrome and neurotoxicity assessment (how many telemedicine visits successfully completed
      per patient)

      Secondary Objective(s)

        -  To determine how many times a telemedicine visit triggered an action (inpatient
           admission/ outpatient observation status)

        -  To determine how many patients were detected to have cytokine release syndrome and/or
           neurotoxicity based on their telemedicine visit
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of Successfully Completed Telemedicine Visits
time frame: 3 years
description: To determine feasibility of telemedicine for outpatient cytokine release syndrome and neurotoxicity assessment. Investigators will consider telemedicine feasible in this population if at least 13 of the 15 patients successfully complete 80% of telemedicine visits. A visit will be considered successful if all measurements are recorded OR if the visit is interrupted because the participant needs to come into the CAR-T unit for assessment. If a patient is admitted, then the 80% benchmark will be calculated based on the number of days the patient was outpatient at 11 pm. The proportion meeting the 80% benchmark will be reported along with an exact 95% confidence interval.
measure: Number of Times a Telemedicine Visit Triggered Action
time frame: 3 years
description: To determine how many times a telemedicine visit triggered an inpatient admission or outpatient observation status
measure: Number of Patients to Have Cytokine Release Syndrome
time frame: 3 years
description: Descriptive statistics will be used to characterize the number of cases of cytokine release syndrome based on telemedicine visits.
measure: Number of Patients to Have Neurotoxicity
time frame: 3 years
description: Descriptive statistics will be used to characterize the number neurotoxicities reported based on telemedicine visits.
arm group label: CAR-T cell therapy and Telemedicine
arm group type: Other
description: All outpatient CAR-T patients will require assessments for cytokine release syndrome and neurotoxicity three times daily (every 8 hours)
intervention type: Other
intervention name: Telemedicine visit
description: Participants will be provided with a Wifi-and cellular enabled electronic tablet. Additionally, participants will receive a kit that contains a thermometer, a blood pressure monitoring cuff, and a pulse oximeter (to measure oxygen saturation level). Participants will attend an educational session to learn how the telemedicine visit works. Caregivers should attend with participants and will be trained to take temperatures, blood pressures, and oxygen saturation levels. Participants will also be asked to complete a test telehealth visit.
arm group label: CAR-T cell therapy and Telemedicine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rakhee Vaidya, MBBS
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Lymphoma, Large B-Cell, Diffuse
mesh term: Cytokine Release Syndrome
sharing ipd: No