Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity Following CAR-T Infusion on an Outpatient Basis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of Successfully Completed Telemedicine Visits
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Number of Successfully Completed Telemedicine Visits
时间窗: 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.
次要结局
- Number of Patients to Have Neurotoxicity(3 years)
- Number of Times a Telemedicine Visit Triggered Action(3 years)
- Number of Patients to Have Cytokine Release Syndrome(3 years)