Clinical trial NCT04503538: Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity
Official title: Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity Following CAR-T Infusion on an Outpatient Basis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Large B-cell Lymphoma
Diffuse Large B Cell Lymphoma
Primary Mediastinal Large B Cell Lymphoma
High-grade B-cell Lymphoma
Follicular Lymphoma
Keywords: Relapsed large B-cell lymphoma
Refractory large B-cell lymphoma
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Eligibility 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.

Primary outcomes:
measure: Number of Successfully Completed Telemedicine Visits
timeFrame: 3 years
Secondary outcomes:
measure: Number of Times a Telemedicine Visit Triggered Action
timeFrame: 3 years
measure: Number of Patients to Have Cytokine Release Syndrome
timeFrame: 3 years
measure: Number of Patients to Have Neurotoxicity
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Rakhee Vaidya, MBBS
role: PRINCIPAL_INVESTIGATOR
References: