Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity

NCT04503538 | Withdrawn DMC

• 2 other identifiers: IRB00067341WFBCCC 99520
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of Successfully Completed Telemedicine Visits

  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.

  3 years

Secondary Outcomes (3)

• Number of Times a Telemedicine Visit Triggered Action

  3 years

• Number of Patients to Have Cytokine Release Syndrome

  3 years

• Number of Patients to Have Neurotoxicity

  3 years

Study Arms (1)

CAR-T cell therapy and Telemedicine

OTHER

All outpatient CAR-T patients will require assessments for cytokine release syndrome and neurotoxicity three times daily (every 8 hours)

Other: Telemedicine visit

Interventions

Telemedicine visit OTHER

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.

CAR-T cell therapy and Telemedicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Rakhee Vaidya, MBBS

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 7, 2020
• Study Start: December 1, 2020
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share