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Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity

Primary Purpose

Large B-cell Lymphoma, Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telemedicine visit
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Large B-cell Lymphoma focused on measuring Relapsed large B-cell lymphoma, Refractory large B-cell lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must have histologically confirmed relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from of follicular lymphoma
  • Age ≥ 18 years
  • ECOG or Karnofsky performance status of ≤ 2
  • Patients must have a caregiver(s) with them 24 hours a day for the first 30 days after CAR-T cell infusion
  • Patients must stay within a 30-minute distance from the cancer center
  • Patients must have access to wifi network or a cellular network
  • Patients and caregiver(s) participating in patient's care must attend the education session for outpatient CAR-T and demonstrate competency to collect vital signs with equipment provided
  • Must have the ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

Exclusion Criteria:

  • Patients who have acute lymphoblastic leukemia/lymphoma
  • Patients who have a high tumor burden (> 10 cm largest mass) have a high risk of CRS who will receive CAR-T as an inpatient
  • Patient or caregiver unable to understand and follow English language
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    CAR-T cell therapy and Telemedicine

    Arm Description

    All outpatient CAR-T patients will require assessments for cytokine release syndrome and neurotoxicity three times daily (every 8 hours)

    Outcomes

    Primary Outcome Measures

    Number of Successfully Completed Telemedicine Visits
    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.

    Secondary Outcome Measures

    Number of Times a Telemedicine Visit Triggered Action
    To determine how many times a telemedicine visit triggered an inpatient admission or outpatient observation status
    Number of Patients to Have Cytokine Release Syndrome
    Descriptive statistics will be used to characterize the number of cases of cytokine release syndrome based on telemedicine visits.
    Number of Patients to Have Neurotoxicity
    Descriptive statistics will be used to characterize the number neurotoxicities reported based on telemedicine visits.

    Full Information

    First Posted
    August 4, 2020
    Last Updated
    October 21, 2020
    Sponsor
    Wake Forest University Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04503538
    Brief Title
    Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity
    Official Title
    Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity Following CAR-T Infusion on an Outpatient Basis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Principal investigator decided not to pursue trial
    Study Start Date
    December 2020 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Large B-cell Lymphoma, Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma, High-grade B-cell Lymphoma, Follicular Lymphoma
    Keywords
    Relapsed large B-cell lymphoma, Refractory large B-cell lymphoma

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CAR-T cell therapy and Telemedicine
    Arm Type
    Other
    Arm 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(s)
    Telemedicine visit
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Number of Successfully Completed Telemedicine Visits
    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.
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Number of Times a Telemedicine Visit Triggered Action
    Description
    To determine how many times a telemedicine visit triggered an inpatient admission or outpatient observation status
    Time Frame
    3 years
    Title
    Number of Patients to Have Cytokine Release Syndrome
    Description
    Descriptive statistics will be used to characterize the number of cases of cytokine release syndrome based on telemedicine visits.
    Time Frame
    3 years
    Title
    Number of Patients to Have Neurotoxicity
    Description
    Descriptive statistics will be used to characterize the number neurotoxicities reported based on telemedicine visits.
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients must have histologically confirmed relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from of follicular lymphoma Age ≥ 18 years ECOG or Karnofsky performance status of ≤ 2 Patients must have a caregiver(s) with them 24 hours a day for the first 30 days after CAR-T cell infusion Patients must stay within a 30-minute distance from the cancer center Patients must have access to wifi network or a cellular network Patients and caregiver(s) participating in patient's care must attend the education session for outpatient CAR-T and demonstrate competency to collect vital signs with equipment provided Must have the ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative). Exclusion Criteria: Patients who have acute lymphoblastic leukemia/lymphoma Patients who have a high tumor burden (> 10 cm largest mass) have a high risk of CRS who will receive CAR-T as an inpatient Patient or caregiver unable to understand and follow English language Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rakhee Vaidya, MBBS
    Organizational Affiliation
    Wake Forest University Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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