Hodgkin LymphomaNCT05123001
Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events
An observational study of Hodgkin Lymphoma and Non Hodgkin Lymphoma, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Lymphoma, Non Hodgkin Lymphoma, Leukemia
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2021to 7 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) receiving standard-of-care CAR-T cell therapy at Stanford University. Participants must be English-speaking and able, with caregiver assistance, to use wearable monitoring devices and perform blood microsampling. Up to 15 patients will be enrolled in this pilot study.
Who may be able to join
- 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
Who cannot join
- In the investigator's judgment, the subject is unlikely to comply with all protocolrequired study visits or procedures.
Trial locations and contacts
1 site in 1 country.
About this study
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):
- To assess the feasibility, including accuracy, usability, and usefulness of wearable sensors in CAR-T patients.
- To generate comprehensive multiomic profile analysis following CAR-T therapy.
- To perform integrated analysis of wearables sensor data, omics data, and symptom/clinical data.
- Conditions
- Hodgkin Lymphoma, Non Hodgkin Lymphoma, Leukemia, Multiple Myeloma
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin, Leukemia, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T patients monitored with wearable devices and microsampling | All participants will receive wearable sensors, provide blood microsamples, and use the Biostrap mobile app for data capture. These are observational data collection tools applied to the entire cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring heart rate data
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.
Measured: 28 days
Monitoring temperature data
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).
Measured: 28 days
Secondary outcomes (3)
Feasibility of microsampling
microsample device collects up to 200 microliters (0.04 teaspoons) of blood from the upper arm
Measured: 28 days
Safety of wearable devices
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
Measured: 28 days
Safety of the microsampling device
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start15 Jul 2021
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Surbhi Sidana, MD, Stanford University
- Investigators
- Surbhi Sidana, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123001
- Sponsor's protocol ID
- IRB-60459
- Other IDs
- NCI-2022-00603
- Status last verified
- Aug 2025
- First submitted
- 29 Oct 2021
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events
- ClinicalTrials.gov ID
- NCT05123001
- Acronym / sponsor ID
- IRB-60459
- Conditions
- Hodgkin Lymphoma, Non Hodgkin Lymphoma, Leukemia, Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- To assess the feasibility, including accuracy, usability, and usefulness of wearable sensors in CAR-T patients.
- To generate comprehensive multiomic profile analysis following CAR-T therapy.
- To perform integrated analysis of wearables sensor data, omics data, and symptom/clinical data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T patients monitored with wearable devices and microsampling | – | –All participants will receive wearable sensors, provide blood microsamples, and use the Biostrap mobile app for data capture. These are observational data collection tools applied to the entire cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) receiving standard-of-care CAR-T cell therapy at Stanford University. Participants must be English-speaking and able, with caregiver assistance, to use wearable monitoring devices and perform blood microsampling. Up to 15 patients will be enrolled in this pilot study.
Key inclusion criteria (5 listed)
- Participant must be in the process of undergoing cancer cell therapy at Stanford University.
Key exclusion criteria (1 listed)
- In the investigator's judgment, the subject is unlikely to comply with all protocolrequired study visits or procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Monitoring heart rate data
Time frame: 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
Time frame: 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).
3 secondary outcomes
Feasibility of microsampling
Time frame: 28 days
Safety of wearable devices
Time frame: 28 days
Safety of the microsampling device
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surbhi Sidana principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin Lymphoma and Non Hodgkin Lymphoma, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring heart rate data (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.