A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice (FIL_MAB)

Fondazione Italiana Linfomi - ETS

Status: Enrolling

Conditions: Non-Hodgkin Lymphoma, B-cell

Treatments: Drug: "novel" MAB (alone or in combination)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06008691

FIL_MAB

Details and patient eligibility

About

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.

Full description

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:

• Per indication analysis;
• Pooled analyses by type of antibody and subtype and other parameters;
• A general analysis of the whole cohort.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Being involved in a prospective interventional trial outside indication.

• Patients treated outside approved indications:

  • 648-approved indication.
  • 5% AIFA support.
  • Compassionate use.

• Age less than 18 years.

• Inability to provide an informed consent.

Trial design

1,500 participants in 1 patient group

B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA and AIFA).

Description:

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.

Treatment:

Drug: "novel" MAB (alone or in combination)