Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity

Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity Following CAR-T Infusion on an Outpatient Basis

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

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.