An observational study in Non-Hodgkin Lymphoma, B-cell, sponsored by Fondazione Italiana Linfomi - ETS. Recruiting at 61 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by Fondazione Italiana Linfomi - ETS · Observational
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.
This is a large prospective, observational cohort study aimed at collecting clinical information on use, feasibility, short- and long-term efficacy and short- and long-term toxicity of novel MAB that have received approval from EMA since 2020 and are prescribed according to the indications for use authorized for marketing in Italy.
Patients entering the study will be subdivided into different cohorts based on approved treatment indications, type of antibody employed and histological subtype. Additional sub-cohorts will be defined if needed.
Final outputs will be based according to:
1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 150 across 159 observational studies indexed under Lymphoma, Non-Hodgkin.
Browse Lymphoma, Non-Hodgkin studies →Fondazione Italiana Linfomi - ETS is the lead sponsor of 89 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Patients treated outside approved indications:
B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA since 2020 and prescribed according to the indications for use authorized for marketing in Italy). Patients first-line and relapsed or refractory who had received at least 1 dose of MAB. Different cohorts will be analyzed according to approved treatment indications, type of antibody employed and NHL hystotypes.
Drug: "novel" MAB (alone or in combination)
"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).
Time frame: At least 5 years
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.
Time frame: At least 5 years
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.
Time frame: At least 5 years
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.
Time frame: At least 5 years
Event free survival (EFS)
ESFS is defined as the time from start of treatment to disease progression, death, or discontinuation of treatment for any reason (e.g. toxicity, patient preference), or initiation of a new treatment without documented progression.
Time frame: At least 5 years
Time-to-next treatment (TTNT)
TTNT represents the interval from commencement of one treatment to initiation of the next line of therapy.
Time frame: At least 5 years
non-relapse mortality (NRM)
NRM is defined as death without recurrent or progressive disease after treatment.
Time frame: At least 5 years
Duration of response (DOR)
DOR is defined as the time from the first documentation of tumor response (CR/PR) to disease progression or death according to Lugano 2014 criteria.
Time frame: At least 5 years
Incidence of Early/Late Adverse Events
Toxicities will be recorded and classified according to the definitions of the latest version of the NCI CTCAE. Toxicity events will be determined by the incidence of severe, life-threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (SAEs) commencing after the first induction dose or at any time during therapy. Early and toxic deaths and cause of any death. Special focus on second tumors, infections and autoimmune complications. Particularly: * Hematological and extra-hematological toxicities Grade \> 2 * Infusional adverse events, will be recorded any Grade * Toxicities of specific interest on second tumors, infections and autoimmune complications will be recorded any Grade * Early and toxic deaths and cause of any death.
Time frame: At least 5 years
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Fondazione Italiana Linfomi - ETS