Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity

Not Applicable

Withdrawn

• Conditions: Diffuse Large B Cell Lymphoma; Large B-cell Lymphoma; Follicular Lymphoma; High-grade B-cell Lymphoma; Primary Mediastinal Large B Cell Lymphoma
• Interventions: Other: Telemedicine visit

• Registration Number: NCT04503538
• Lead Sponsor: 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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-23
• Study Start: 2020-12
• Primary Completion: 2023-09
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAR-T cell therapy and Telemedicine	Telemedicine visit	All outpatient CAR-T patients will require assessments for cytokine release syndrome and neurotoxicity three times daily (every 8 hours)

Primary Outcome Measures

Name	Time	Method
Number of Successfully Completed Telemedicine Visits	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

Name	Time	Method
Number of Patients to Have Neurotoxicity	3 years	Descriptive statistics will be used to characterize the number neurotoxicities reported based on telemedicine visits.
Number of Times a Telemedicine Visit Triggered Action	3 years	To determine how many times a telemedicine visit triggered an inpatient admission or outpatient observation status
Number of Patients to Have Cytokine Release Syndrome	3 years	Descriptive statistics will be used to characterize the number of cases of cytokine release syndrome based on telemedicine visits.