Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor (CAR-T) Therapy
Recruiting
Phase 3Interventional Study
Hematologic Malignancies
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Supportive Care
Participants needed
190 (estimated)
Sponsor
City of Hope Medical Center · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
The overall purpose of this randomized control trial (RCT) is to determine the clinical effect of a multilevel, RPM-enhanced intervention during and after completion of outpatient CAR-T therapy in 190 patients and their family caregivers (FCGs).
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
Patient Inclusion Criteria Informed Consent and Willingness to Participate
1. Documented informed consent of the participant and/or legally authorized representative Age and Language Criteria
2. Age ≥ 18 years old at the time of enrollment
3. Ability to read and understand Engl…
Inclusion Criteria:
Patient Inclusion Criteria Informed Consent and Willingness to Participate
1. Documented informed consent of the participant and/or legally authorized representative Age and Language Criteria
2. Age ≥ 18 years old at the time of enrollment
3. Ability to read and understand English or Spanish for Questionnaires Nature of Illness and Treatment Related Criteria
4. Relapsed or refractory hematologic malignancy
5. Scheduled to receive outpatient standard of care (SOC) CAR-T therapy
6. Has a FCG committed to living with the patient for the duration of the study
Family Caregiver Inclusion Criteria Informed Consent and Willingness to Participate
1. Documented informed consent of the participant and/or legally authorized representative Age and Language Criteria
2. Age ≥ 18 years old at the time of enrollment
3. Ability to read and understand English or Spanish for Questionnaires Nature of Illness and Treatment Related Criteria
4. Family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care
Exclusion Criteria 1. An employee who is under the direct/indirect supervision of the PI/ a co-investigator/ the study manager 2. A direct study team member
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