NCT07882732Toborzás még nem indult
RPM Signals in Outpatient CAR T Therapy
Characterizing Remote Patient Monitoring Signals During Outpatient CAR T Therapy: A Prospective Observational Cohort Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 20.
Rövid összefoglaló (regiszter, angolul)
The goal of this observational study is to learn how patients' vital signs and symptoms change during outpatient CAR T-cell therapy with lisocabtagene maraleucel (liso-cel), a type of cancer treatment. The study tracks vital signs and other health data at home using wearable monitoring devices. It includes adults with blood cancers who are receiving liso-cel as outpatients, meaning they are at home rather than staying in the hospital during treatment. The main questions it aims to answer are: * What do patients' vital signs and monitoring data look like from 3 days before through 14 days after their CAR T-cell infusion, and what side effects do they experience, such as cytokine release syndrome (a fever and inflammation reaction) and neurological side effects? * How are patients' individual characteristics and monitoring data related to these side effects? Participants will: * Use the Current Health home monitoring kit, including a wearable device that tracks breathing rate, pulse, oxygen levels, skin temperature, and step count, plus a blood pressure cuff, a temperature patch, a thermometer, a tablet, and a device that sends data without needing home internet. Monitoring starts 3 days before infusion and continues for 14 days afterward, pausing during any hospital stays. * Answer short questions about their experience on the tablet. * Continue their regular medical care and appointments. The study team will collect information from their medical records, such as test results, treatment details, and any side effects or complications. Participants receive CAR T-cell therapy as part of their regular care. The study does not test or change any treatment. Researchers are only observing and recording what happens during this at-home care model.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 125 (tervezett)
- Első benyújtás
- 2026. szept. 29.
- Kezdés
- 2026. dec. 1.
- Elsődleges befejezés
- 2027. dec. 1.
- Fő szponzor
- Current Health
- Betegségek
- Krónikus limfoid leukémia (CLL)
- NCT-szám
- NCT07882732
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 125
- 2026. dec. 1. és az elsődleges befejezés (2027. dec. 1.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Életkor
- Age under 18 years
Egyéb
- Inability or unwillingness to provide informed consent
- Inpatient admission planned at time of enrollment
- Any contraindication to use the Current Health wearable device as listed by the device manufacturer in the device Instructions For Use.
- Participation in another interventional study that would confound study outcomes, unless approved by both studies' principal investigators.
Kiket keres a vizsgálat
- Patients scheduled to receive liso-cel as an outpatient for a hematologic malignancy at a participating institution
- Meet the participating institution's outpatient CAR T program's eligibility criteria
- Able to use and return the monitoring device
- English- or Spanish-speaking and willing to use the interpreter services available via the platform if needed
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.