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Recruiting NCT06008691

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

— Observational Non-Hodgkin Lymphoma, B-cell

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: "novel" MAB (alone or in combination).
Who it may be relevant to
Registry conditions: Non-Hodgkin Lymphoma, B-cell. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed 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.

Interventions

  • 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

Primary outcome measures

  • Overall response rate (ORR) [Time frame: At least 5 years]
  • Complete Response rate (CRR) [Time frame: At least 5 years]
  • Progression free survival (PFS) [Time frame: At least 5 years]
  • Overall survival (OS) [Time frame: At least 5 years]
  • Event free survival (EFS) [Time frame: At least 5 years]
  • Time-to-next treatment (TTNT) [Time frame: At least 5 years]
  • non-relapse mortality (NRM) [Time frame: At least 5 years]
  • Duration of response (DOR) [Time frame: At least 5 years]
  • Incidence of Early/Late Adverse Events [Time frame: At least 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 61 centers
  • Istituto Oncologico del Mediterraneo SPA - Oncologico — Viagrande
  • Ospedale SS. Cosma e Damiano - Ospedale San Jacopo - SOS Oncoematologia ed ematologia clin — Pescia
  • A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia — Alessandria
  • AOU Ospedali Riuniti - Clinica di Ematologia — Ancona
  • Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico — Avellino
  • IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori imm — Aviano
  • IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia — Bari
  • Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia — Barletta
  • … and 53 more centers

Identifiers

NCT: NCT06008691 · FIL_MAB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗