Italian Observational Study on CAR-T Therapy for Lymphoma

Condition(s) studied

Study 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.

Eligibility

Primary outcome measure(s)

• Feasibility of the CAR-T cells treatment in lymphomas in the italian real life practice — 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.
• Efficacy of the CAR-T cells treatment in lymphomas in the italian real life practice — 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)

Trial sites (1)

Other trials for the same condition