Observational study on patients receiving CAR-T cell therapy
Tissue Study in Patients Undergoing CAR-T Cell Therapy
This study looks at patients receiving CAR-T cell therapy for blood cancers to see how their bodies react and what complications might come up, with the goal of improving treatment and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | CAR-T, Chimeric Antigen Receptor, immunotherapy, CAR T, chemotherapy |
| Locations | 1 site (Bologna, Italy) |
| Trial ID | NCT04892433 on ClinicalTrials.gov |
What this trial studies
This study observes patients undergoing CAR-T cell therapy for various oncohematological conditions, focusing on the biological mechanisms and complications associated with the treatment. It aims to analyze DNA-methylation patterns, microRNA expression, and the populations of lymphocytes and myeloid cells in these patients. By collecting and analyzing tissue samples, the study seeks to enhance understanding of the immune response and potential complications arising from CAR-T therapy. The findings may contribute to improving patient outcomes and refining treatment protocols.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are undergoing CAR-T therapy for hematological malignancies.
Not a fit: Patients with non-hematological conditions or those not undergoing CAR-T therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management of complications associated with CAR-T therapy, ultimately improving patient outcomes.
How similar studies have performed: While CAR-T therapy is a well-established treatment, this specific observational approach focusing on tissue analysis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients aged ≥ 18 years. Patients with haematological pathology admitted to be subjected to CAR-T Therapy at the Advanced Cell Therapy Program, IRCCS University Hospital of Bologna. Patients who consent to participate in this study after signing informed consent. Exclusion Criteria: \-
Where this trial is running
Bologna, Italy
- IRCC, University Hospital of Bologna — Bologna, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Francesca Bonifazi, MD — Advanced Cell Therapy Program, IRCCS University Hospital of Bologna
- Study coordinator: Franscesca Bonifazi, MD
- Email: francesca.bonifazi@unibo.it
- Phone: +39 0512143799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.