Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity
Primary Purpose
Large B-cell Lymphoma, Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B Cell Lymphoma
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telemedicine visit
Sponsored by
About this trial
This is an interventional supportive care trial for Large B-cell Lymphoma focused on measuring Relapsed large B-cell lymphoma, Refractory large B-cell lymphoma
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CAR-T cell therapy and Telemedicine
Arm Description
All outpatient CAR-T patients will require assessments for cytokine release syndrome and neurotoxicity three times daily (every 8 hours)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Times a Telemedicine Visit Triggered Action
To determine how many times a telemedicine visit triggered an inpatient admission or outpatient observation status
Number of Patients to Have Cytokine Release Syndrome
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
Descriptive statistics will be used to characterize the number neurotoxicities reported based on telemedicine visits.
Full Information
NCT ID
NCT04503538
First Posted
August 4, 2020
Last Updated
October 21, 2020
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04503538
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Principal investigator decided not to pursue trial
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAR-T cell therapy and Telemedicine
Arm Type
Other
Arm Description
All outpatient CAR-T patients will require assessments for cytokine release syndrome and neurotoxicity three times daily (every 8 hours)
Intervention Type
Other
Intervention Name(s)
Telemedicine visit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Successfully Completed Telemedicine Visits
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Number of Times a Telemedicine Visit Triggered Action
Description
To determine how many times a telemedicine visit triggered an inpatient admission or outpatient observation status
Time Frame
3 years
Title
Number of Patients to Have Cytokine Release Syndrome
Description
Descriptive statistics will be used to characterize the number of cases of cytokine release syndrome based on telemedicine visits.
Time Frame
3 years
Title
Number of Patients to Have Neurotoxicity
Description
Descriptive statistics will be used to characterize the number neurotoxicities reported based on telemedicine visits.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakhee Vaidya, MBBS
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity
We'll reach out to this number within 24 hrs