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NCT05123001 | RECRUITING | Hodgkin Lymphoma

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

Stanford University

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.

Condition or disease

Hodgkin Lymphoma

Non Hodgkin Lymphoma

Leukemia

Multiple Myeloma

Intervention/treatment

Biostrap arm band

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 15 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events
Actual Study Start Date : 2021-07-15
Estimated Primary Completion Date : 2025-07
Estimated Study Completion Date : 2025-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events

Location Details

NCT05123001

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Stanford University

Palo Alto, California, United States, 94305