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Clinical Trial 20611

Cancer Type: Immunotherapy
Study Type: Device Feasibility
NCT#:

Phase: N/A
Prinicipal Investigator: Hansen, Doris

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or 1-800-679-0775 Learn More
Overview

Study Title

An Observational Study to Evaluate a Wearable Temperature Monitoring Device in Subjects Receiving CAR-T Therapy

Summary

The purpose of the study is to evaluate patient use of a digital temperature Remote Patient Monitoring (RPM) System in addition to the use of an oral thermometer, before and after study treatment with CAR-T therapy.

Objective

Treatments

Therapies

Medications

Inclusion Criteria

Inclusion Criteria:

  • At least 18 years of age or older at time of consent
  • Signed informed consent form obtained prior to any study procedures
  • Confirmed enrollment on a Celgene CAR-T study and have undergone leukapheresis to enable CAR-T product generation
  • Patient must reside in the US
  • Patient is able to adhere to protocol requirements
  • Additional criteria may apply

  • Exclusion Criteria

    Exclusion Criteria:

  • Patients who have a visible skin condition in the axillary region(s) upon inspection by the research nurse
  • Patients that are highly sensitive or allergic to silicone
  • Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or unwillingness or inability to follow the procedures required in the protocol
  • A patient who has already been administered the CAR-T therapy
  • Patient is unwilling or unable to wear the device or to use a smartphone or other Bluetooth connected device for the duration of the study
  • Patient has a condition which places them at unacceptable risk, as deemed by the Investigator
  • Additional criteria may apply

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.