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Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity

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ClinicalTrials.gov Identifier: NCT04503538
Recruitment Status : Withdrawn (Principal investigator decided not to pursue trial)
First Posted : August 7, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Large B-cell Lymphoma Diffuse Large B Cell Lymphoma Primary Mediastinal Large B Cell Lymphoma High-grade B-cell Lymphoma Follicular Lymphoma Other: Telemedicine visit Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity Following CAR-T Infusion on an Outpatient Basis
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : November 2023


Arm Intervention/treatment
CAR-T cell therapy and Telemedicine
All outpatient CAR-T patients will require assessments for cytokine release syndrome and neurotoxicity three times daily (every 8 hours)
Other: Telemedicine visit
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 Measures :
  1. Number of Successfully Completed Telemedicine Visits [ Time Frame: 3 years ]
    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 :
  1. Number of Times a Telemedicine Visit Triggered Action [ Time Frame: 3 years ]
    To determine how many times a telemedicine visit triggered an inpatient admission or outpatient observation status

  2. Number of Patients to Have Cytokine Release Syndrome [ Time Frame: 3 years ]
    Descriptive statistics will be used to characterize the number of cases of cytokine release syndrome based on telemedicine visits.

  3. Number of Patients to Have Neurotoxicity [ Time Frame: 3 years ]
    Descriptive statistics will be used to characterize the number neurotoxicities reported based on telemedicine visits.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04503538


Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Rakhee Vaidya, MBBS Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04503538    
Other Study ID Numbers: IRB00067341
WFBCCC 99520 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center )
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Relapsed large B-cell lymphoma
Refractory large B-cell lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Cytokine Release Syndrome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock