Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04503538

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

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	N/A

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

Study Design

Study Type:

Interventional

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

Anticipated Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.