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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 5,300
- Locations
- 1
- Primary Endpoint
- Efficacy of the CAR-T cells treatment in lymphomas in the italian real life practice
Study Overview
Brief Summary
The goal of this observational study on chimeric antigen receptor T-cell therapy is to monitor the feasibility, efficacy, toxicity and biomarkers in a real life setting.
Partecipants will be asked to agree to their clinical data collection and to partecipate to the optional biological study that aims to evaluate biomarkers of toxicity and response (clinical characteristics, cytokine profile, cellcomposition and type of the CAR-T cell product, lymphoma genomics). The study will evaluate even the disease response according to lugano criteria by PET and CT in routine clinical activity.
Detailed Description
This observational prosopective multicenter study aims to:
- evaluate the feasibility of CAR T-cell treatment in the real-life setting, with particular regard to eligible patients versus those subjected to leukapheresis versus those finally treated.
- evaluate the survival outcome of PMBCL, DLBCL, MCL and FL patients treated with CAR T-cells versus those potentially eligible, but excluded from cellular therapy for other causes (either related to the patient or to the manufacturing);
- monitor the incidence of early and late AEs up to three year after CAR-T;
- evaluate disease response and immune recovery biomarkers at different time-points up after CAR-T (when clinically indicated or using blood sampling leftover);
- evaluate biomarkers of toxicity and response (clinical characteristics, cytokine profile, cell composition and type of the CAR T-cell product, lymphoma genomics).
- evaluate disease response according to Lugano criteria by PET and CT in routine clinical activity.
Primary Objective:
• Feasibility and efficacy of the treatment in the real life practice
Secondary Objectives:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Efficacy of the CAR-T cells treatment in lymphomas in the italian real life practice
Time Frame: 10 years enrollment, minimum 1 year follow-up
Evaluate the survival outcome of PMBCL, DLBCL, MCL and FL patients treated with CAR T-cells versus those potentially eligible, but excluded from cellular therapy for other causes (either related to the patient or to the manufacturing)
Feasibility of the CAR-T cells treatment in lymphomas in the italian real life practice
Time Frame: 10 years enrollment, minimum 1 year follow-up
Evaluate the feasibility of CAR T-cell treatment in the real-life setting, with particular regard to eligible patients versus those subjected to leukapheresis versus those finally treated. The percentage of patients infused will be estimated as the number of patients infused divided by the total number of those declared eligible; the corresponding exact confidence intervals at 95% will also be estimated.
Secondary Outcomes
- Evaluation of Outcome: duration of response (DoR)(10 years, minimum f-up 1 year)
- Evaluation of bridging therapy: efficay(10 years, minimum f-up 1 year)
- Evaluation of Outcome: Overall survival (OS), according to Lugano criteria.(10 years, minimum f-up 1 year)
- Evaluation of bridging therapy: safety(10 years, minimum f-up 1 year)
- Evaluation of Outcome: non-relapse mortality (NRM)(10 years, minimum f-up 1 year)
- Evaluation of safety (CRS, neurotoxicity, infections, cytopenias, B cell aplasia, second malignancies) with particular attention to the safety in the new indications(10 years, minimum f-up 1 year)
- Comparison of the different histotypes (PMBCL, DLBCL, MCL FL) according to CAR-T cell products(10 years, minimum f-up 1 year)
- Evaluation of Outcome: Overall Response rate (ORR), according to Lugano criteria.(10 years, minimum f-up 1 year)
- Evaluation of Outcome: Progression free survival (PFS)(10 years, minimum f-up 1 year)
- Evaluation of Outcome: Overall Response rate (ORR)(10 years, minimum f-up 1 year)
- Evaluation of Outcome: Overall survival (OS)(10 years, minimum f-up 1 year)
- Evaluation of salvage therapy after CAR-T failure(10 years, minimum f-up 1 year)
- Comparison of the different CAR T-cell products (time from patient screening to infusion, disease response and safety)(10 years, minimum f-up 1 year)
Investigators
Paolo Corradini
Professor, director of hematology Unit
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano