Status:
WITHDRAWN
Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Large B-cell Lymphoma
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 vi...
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) Sec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04503538
Start Date
December 1 2020
End Date
November 1 2023
Last Update
October 23 2020
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