Observational study on CAR-T therapy for lymphoma in Italy
A Multicenter Prospective Observational Study on Chimeric Antigen Receptor (CAR) T-cell Therapy for Lymphoma: Monitoring Feasibility, Efficacy, Toxicity and Biomarkers in a Real Life Setting
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · NCT06339255
This study looks at how well CAR-T therapy works and its side effects for people with lymphoma in Italy by tracking their health over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (other) |
| Drugs / interventions | CAR-T, chimeric antigen receptor, CAR T |
| Locations | 1 site (Milan) |
| Trial ID | NCT06339255 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor the feasibility, efficacy, and toxicity of CAR-T therapy for various types of lymphoma in a real-life setting. Participants will consent to the collection of their clinical data and may take part in an optional biological study to evaluate biomarkers related to toxicity and treatment response. The study will assess disease response using PET and CT scans according to Lugano criteria, and will track patient outcomes over a three-year period. It will also compare survival outcomes between treated patients and those who were eligible but did not receive treatment.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with diffuse low-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, mantle cell lymphoma, or follicular lymphoma who are eligible for CAR-T treatment.
Not a fit: Patients who are not eligible for CAR-T therapy or those with contraindications to the treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of CAR-T therapy for lymphoma patients.
How similar studies have performed: Other studies have shown promising results with CAR-T therapy in similar patient populations, indicating that this approach is supported by prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with diagnosis of DLCBL, PMBCL, MCL and FL eligible for CAR-T treatment with commercialy available products in Italy. Exclusion Criteria: * Not applicable
Where this trial is running
Milan
- Fondazione IRCCS Istituto Nazionale Tumori — Milan, Italy (RECRUITING)
Study contacts
- Study coordinator: Paolo Corradini, Professor
- Email: paolo.corradini@istitutotumori.mi.it
- Phone: +39 02 2390 2950
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.
Conditions: Diffuse Low Grade B-Cell Lymphoma, Primary Mediastinal Large B-cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, CAR-T, Lymphoma