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Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events

Primary Purpose

Hodgkin Lymphoma, Non Hodgkin Lymphoma, Leukemia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biostrap arm band
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hodgkin Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Device physiological monitoring

Microsampling

Biostrap mobile App

Arm Description

Patients will receive wearable sensor devices (Biostrap arm band)

Blood microsamples will be collected at start of conditioning chemotherapy, daily while in the hospital, and after leaving the hospital and outpatient appointments.

Data collection from wearable sensor.

Outcomes

Primary Outcome Measures

Monitoring heart rate data
Monitoring temperature data

Secondary Outcome Measures

Microsampling
microsample device collects up to 200 microliters (0.04 teaspoons) of blood from the upper arm
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
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

Full Information

First Posted
October 29, 2021
Last Updated
March 29, 2022
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT05123001
Brief Title
Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events
Official Title
Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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): 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma, Non Hodgkin Lymphoma, Leukemia, Multiple Myeloma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Device physiological monitoring
Arm Type
Experimental
Arm Description
Patients will receive wearable sensor devices (Biostrap arm band)
Arm Title
Microsampling
Arm Type
No Intervention
Arm Description
Blood microsamples will be collected at start of conditioning chemotherapy, daily while in the hospital, and after leaving the hospital and outpatient appointments.
Arm Title
Biostrap mobile App
Arm Type
No Intervention
Arm Description
Data collection from wearable sensor.
Intervention Type
Device
Intervention Name(s)
Biostrap arm band
Intervention Description
The Biostrap mobile app will connect with the Biostrap arm band and temperature sensor.
Primary Outcome Measure Information:
Title
Monitoring heart rate data
Time Frame
28 days
Title
Monitoring temperature data
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Microsampling
Description
microsample device collects up to 200 microliters (0.04 teaspoons) of blood from the upper arm
Time Frame
28 days
Title
Safety of wearable devices
Description
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
Time Frame
28 days
Title
Safety of the microsampling device
Description
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
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharan Claire
Phone
650-721-4091
Email
sharanclaire@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Surbhi Sidana
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharan Claire
Phone
650-721-4091
Email
sharanclaire@stanford.edu
First Name & Middle Initial & Last Name & Degree
Surbhi Sidana, MD
First Name & Middle Initial & Last Name & Degree
Michael P. Snyder, PhD
First Name & Middle Initial & Last Name & Degree
David Miklos, MD, PhD
First Name & Middle Initial & Last Name & Degree
Matthew Frank, MD, PhD
First Name & Middle Initial & Last Name & Degree
Theresa Latchford, MS
First Name & Middle Initial & Last Name & Degree
Ryan Kellogg, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events

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