Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity

Wake Forest University (WFU)

Status

Withdrawn

Conditions

Primary Mediastinal Large B Cell Lymphoma

Follicular Lymphoma

Large B-cell Lymphoma

High-grade B-cell Lymphoma

Diffuse Large B Cell Lymphoma

Treatments

Other: Telemedicine visit

Study type

Interventional

Funder types

Other

Identifiers

NCT04503538

IRB00067341

WFBCCC 99520 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

18+ years old

Volunteers

No 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.