This is a prospective, observational cohort study to evaluate the clinical impact of novel Monoclonal AntiBodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian clinical practice.
Patients with diagnosis of B-cell NHL and need of treatment (as per guideline indications), both first-line and relapsed or refractory.
Patients aimed to be treated in indication with a "novel" MAB (alone or in combination) based on presence of an EMA clinical indication since 2020 and prescribed according to the indications for use authorized for marketing in Italy.
Signed written informed consent.
Being involved in a prospective interventional trial outside indication.
648-approved indication.
5% AIFA support.
Compassionate use.
Patients with diagnosis of B-cell NHL both first-line and relapsed or refractory aimed to be treated in indication with a "novel" MAB (alone or in combination) based on presence of an EMA clinical indication since 2020 and prescribed according to the indications for use authorized for marketing in Italy.
Cohort
Prospective
"novel" MAB (alone or in combination)
Drug"novel" MAB (alone or in combination) based on presence of an EMA clinical indication since 2020 and prescribed according to the indications for use authorized for marketing in Italy
Overall response rate (ORR)
ORR will be defined according to Lugano 2014 criteria as the proportion of patients who have a partial response (PR) or complete response to therapy (CR+PR).
Complete Response rate (CRR)
CRR will be defined according to Lugano 2014 criteria and will include only patients who achieved a CR at the end of treatment program. The best overall response will be defined as the best response between the date of beginning of therapy and the last restaging. Patients without response assessment (due to whatever reason) will be considered as non-responders.
Progression free survival (PFS)
PFS is defined as the time between the date of enrollment and the first documentation of recurrence, progression or death from any cause; responding patients and patients who are lost to follow up will be censored at their last assessment date.
Overall survival (OS)
OS is defined as the time between the start of treatment until death from any cause; patients who are lost at follow up will be censored at their last assessment date.
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Fondazione Italiana Linfomi - ETS
Lead sponsor
Roche Pharma AG
Collaborator
