Actively Recruiting
Study of Extracellular Vesicles in Patients Undergoing CAR-T Cell Therapy for Hematologic Malignancies
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2024-12-27
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the role of extracellular vesicles (EV) as potential biomarkers in patients with refractory or relapsed hematologic cancers undergoing CAR-T cell therapy. The study aims to identify EV biomarkers related to neurological toxicity after CAR-T infusion and to better understand factors that predict treatment outcomes and side effects. The study includes patients who are receiving or are candidates for CAR-T cell therapy for hematologic malignancies such as refractory or relapsed B cell lymphoma, B cell acute leukemia, and multiple myeloma. A total of 100 patients will be enrolled during an 18-month period, including both prospective and retrospective participants. There is no intervention beyond observation since this is an observational study. Participants will be followed to assess their response to CAR-T cell treatment over 18 months. Researchers will collect data related to extracellular vesicles and neurological side effects after therapy. The main outcome measured is the response rate to CAR-T cell treatment. Participants will provide written consent and be observed throughout the study period, which lasts until August 2026.
CONDITIONS
Brief Title
Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients affected by any hematological malignancies (refractory/relapsed B cell lymphoma, B cell acute leukemia, and multiple myeloma) undergoing or with indication to CAR-T cell infusion with a CAR-T cell product
- Age 18 years or greater
- Obtained written consent to study participation
You will not qualify if you...
- None
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 18 months
Participants who undergo CAR-T cell therapy are observed to study extracellular vesicles related to their treatment.
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
Research Team
F
Francesca Bonifazi
E
Enrica Tomassini
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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