Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04503538|
Recruitment Status : Withdrawn (Principal investigator decided not to pursue trial)
First Posted : August 7, 2020
Last Update Posted : October 23, 2020
|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||Not Applicable|
Primary Objective: To determine feasibility of telemedicine for outpatient cytokine release syndrome and neurotoxicity assessment (how many telemedicine visits successfully completed per patient)
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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|
|Estimated Study Start Date :||December 2020|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||November 2023|
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.
- Number of Successfully Completed Telemedicine Visits [ Time Frame: 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.
- Number of Times a Telemedicine Visit Triggered Action [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 years ]Descriptive statistics will be used to characterize the number neurotoxicities reported based on telemedicine visits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04503538
|Principal Investigator:||Rakhee Vaidya, MBBS||Wake Forest University Health Sciences|