Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor (CAR-T) Therapy
NCT07186192 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 190
Last updated 2026-01-28
Summary
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).
Conditions
Interventions
- OTHER
-
Educational Intervention
Patients and family caregivers that are randomized into the intervetnion arm (Digital health intervention) will receive a 90 day nurse-drive, digital health intervention. Participate in self-management coaching sessions
- PROCEDURE
-
Health Telemonitoring
Wear a FitBit device and use a mobile app for nurse tracking
- OTHER
-
Questionnaire Administration
Ancillary studies
- OTHER
-
Best Practice
Given usual care
Sponsors & Collaborators
-
United States Department of Defense
collaborator FED -
City of Hope Medical Center
lead OTHER
Principal Investigators
-
Virginia Sun, PhD, RN · City of Hope Medical Center
-
Saro Armenian, DO, MPH · City of Hope Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-01-14
- Primary Completion
- 2029-03-29
- Completion
- 2029-03-29
Countries
- United States
Study Locations
More Related Trials
-
Anti-CD19, Dual Co-stimulatory (4-1BB, CD3ζ) Chimeric Antigen Receptor T-cells in Patients With Relapsed/Refractory Aggressive Lymphoma or Acute Lymphoblastic Leukemia (ALL)
NCT03938987 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Study of CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell
NCT03019055 ·Status: COMPLETED ·Phase: PHASE1
-
Anti-CD19:TCRζ Chimeric Antigen Receptor-T Cells in the Treatment for CD19+ B Cell Lymphoma
NCT02992834 ·Status: UNKNOWN ·Phase: PHASE4
-
Study Evaluating the Efficacy and Safety With CAR-T Immunotherapy for CD19 Positive Lymphoma
NCT03086954 ·Status: UNKNOWN ·Phase: PHASE1
-
Autologous Cells Derived Anti-CD19 CAR-Engineered T Cells With Concurrent BTK Inhibitor for B Cell Lymphoma
NCT05020392 ·Status: UNKNOWN ·Phase: PHASE3
-
Immunotherapy With CD19 CART-cells for B Cell Acute Lymphoblastic Leukemia
NCT03599375 ·Status: UNKNOWN ·Phase: PHASE1
-
4SCAR19U T Cells Targeting B Cell Malignancies
NCT05995015 ·Status: RECRUITING ·Phase: PHASE1
-
Immunotherapy With CD19 CAR γδT-cells for B-Cell Lymphoma, ALL and CLL
NCT02656147 ·Status: UNKNOWN ·Phase: PHASE1
-
Treatment of Relapsed and/or Chemotherapy Refractory B-cell Malignancy by Tandem CAR T Cells Targeting CD19 and CD22
NCT03185494 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Novel Allogenic CD19-targeting CAR-γδT Cell Therapy (QH103E) in r/r NHL
NCT06838832 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
CART-19 Immunotherapy in Mantle Cell Lymphoma
NCT02081937 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Treatment of Chemotherapy Refractory Human Epidermalgrowth Factor Receptor-2( HER-2) Positive Advanced Solid Tumors
NCT01935843 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Safety and Efficacy Evaluation of Next-generation CD19-UCART
NCT05381181 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed/Refractory CD19+ Malignancies
NCT06227026 ·Status: RECRUITING ·Phase: PHASE1
-
Immunological Parameters, Neurocognitive Changes, Activity, & Driving Fitness in Patients Undergoing CAR-T Cell Therapy
NCT04275154 ·Status: WITHDRAWN
-
CD7 CAR-T Combined With Autologous Hematopoietic Stem Cell Transplantation
NCT07117305 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
Phase I/IIA Study of CART19 Cells for Patients With Chemotherapy Resistant or Refractory CD19+ Leukemia and Lymphoma
NCT01626495 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
IVIG for Infection Prevention After CAR-T-Cell Therapy
NCT05952804 ·Status: RECRUITING ·Phase: PHASE2
-
Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Relapsed and Refractory Lymphoma
NCT03468153 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Humanized CD19-Specific CAR T Cells for the Treatment of Patients With Positive Relapsed or Refractory CD19 Positive B-Cell Acute Lymphoblastic Leukemia
NCT06447987 ·Status: RECRUITING ·Phase: PHASE1
-
Study of CAR-T Therapy in Older Patients
NCT04300998 ·Status: RECRUITING
-
Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc
NCT05366179 ·Status: RECRUITING ·Phase: PHASE1
-
Long-term Follow-up Study of Patients Receiving CAR-T Cells
NCT03375619 ·Status: RECRUITING
-
A Study to Assess CD19-targeted Immunotherapy T Cells in Patients With Relapsed or Refractory CD19+ B Cell Leukemia
NCT02672501 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Clinical Study on the Safety and Efficacy of CD7-Targeted Chimeric Antigen Receptor (CAR) Gene-Modified T Cells for the Treatment of CD7-Positive Hematological Malignancies
NCT07345780 ·Status: NOT_YET_RECRUITING ·Phase: NA