Hodgkin Lymphoma, Leukemia, Multiple Myeloma, Non Hodgkin Lymphoma
Conditions
Brief summary
The purpose of this study is to monitor physiological and molecular changes during and following CAR-T cancer cell therapy, towards improved management of adverse events including Cytokine Release Syndrome and neurotoxicity. Our study aims are to improved early detection and precise management of adverse events for patients receiving Chimeric antigen receptor T- cell (CAR-T): 1. To assess the feasibility, including accuracy, usability, and usefulness of wearable sensors in CAR-T patients. 2. To generate comprehensive multiomic profile analysis following CAR-T therapy. 3. To perform integrated analysis of wearables sensor data, omics data, and symptom/clinical data.
Interventions
None listed
Sponsors
Stanford University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must be in the process of undergoing cancer cell therapy at Stanford University. * Adults \> 18 years * Any cell target may be used. (e.g. CD19, CD22, Bispecific CD19/22, Bispecific CD19/20, etc.) * English speaking * Assessed ability for caregiver/patient to use wearable devices and independently perform blood microsample collection
Exclusion criteria
* In the investigator's judgment, the subject is unlikely to comply with all protocolrequired study visits or procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monitoring heart rate data | 28 days | Defined as ≥70% of patients able to wear at least one sensor device for ≥50% of the days from CAR-T infusion (Day 0) to Day 28. Each day is counted if ≥12 hours of data are captured. |
| Monitoring temperature data | 28 days | Proportion of patients able to wear at least one sensor device for ≥50% of days from Day 0 (CAR-T infusion) through Day 28, with ≥12 hours/day of usable data collected (temperature, heart rate). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of wearable devices | 28 days | Safety will be measured by skin irritation, rash. Will be assessed using CTCAE criteria version 5 to evaluate by any adverse event definitely, probably or possibly related to the wearable devices |
| Safety of the microsampling device | 28 days | Microsampling will be measured by process such as minor bruising, bleeding, or infection. Will be assessed using CTCAE criteria version 5 to evaluate by any adverse event definitely, probably or possibly related to the wearable devices |
| Feasibility of microsampling | 28 days | microsample device collects up to 200 microliters (0.04 teaspoons) of blood from the upper arm |
Countries
United States
Outcome results
None listed