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

Last updated: December 27, 2024
Sponsor: Fondazione Italiana Linfomi - ETS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma, B-cell

Lymphoma

Treatment

"novel" MAB (alone or in combination)

Clinical Study ID

NCT06008691
FIL_MAB
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with diagnosis of B-cell NHL and need of treatment (as per guidelineindications), both first-line and relapsed or refractory.

  • Patients aimed to be treated in indication with a "novel" MAB (alone or incombination) based on presence of an EMA clinical indication since 2020 andprescribed according to the indications for use authorized for marketing in Italy.

  • Signed written informed consent.

Exclusion

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.

Study Design

Total Participants: 1500
Treatment Group(s): 1
Primary Treatment: "novel" MAB (alone or in combination)
Phase:
Study Start date:
December 27, 2023
Estimated Completion Date:
October 31, 2038

Study 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.

Connect with a study center

  • Istituto Oncologico del Mediterraneo SPA - Oncologico

    Viagrande, Catania
    Italy

    Site Not Available

  • Ospedale SS. Cosma e Damiano - Ospedale San Jacopo - SOS Oncoematologia ed ematologia clinica

    Pescia, Pistoia
    Italy

    Site Not Available

  • A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia

    Alessandria,
    Italy

    Active - Recruiting

  • AOU Ospedali Riuniti - Clinica di Ematologia

    Ancona,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico

    Avellino,
    Italy

    Active - Recruiting

  • IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati

    Aviano,
    Italy

    Active - Recruiting

  • IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia

    Bari,
    Italy

    Active - Recruiting

  • Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia

    Barletta,
    Italy

    Site Not Available

  • Azienda Ospedaliera Papa Giovanni XXIII - Ematologia

    Bergamo,
    Italy

    Active - Recruiting

  • Nuovo Ospedale degli Infermi - SSD Ematologia

    Biella,
    Italy

    Active - Recruiting

  • Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Seragnoli"

    Bologna,
    Italy

    Active - Recruiting

  • ASST Spedali Civili di Brescia - Ematologia

    Brescia,
    Italy

    Site Not Available

  • Ospedale Businco - SC Ematologia e CTMO

    Cagliari,
    Italy

    Site Not Available

  • Fondazione del Piemonte per l'Oncologia - IRCCS - Ematologia

    Candiolo,
    Italy

    Active - Recruiting

  • Osp. civile di Carrara - Oncologia Medica

    Carrara,
    Italy

    Active - Recruiting

  • Ospedale di Castelfranco Veneto - Ematologia

    Castelfranco Veneto,
    Italy

    Active - Recruiting

  • Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia

    Catania,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia

    Catania,
    Italy

    Site Not Available

  • Ospedale di Civitanova Marche - UOSD EMATOLOGIA AREA VASTA 3 MACERATA

    Civitanova Marche,
    Italy

    Active - Recruiting

  • A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo

    Cuneo,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

    Firenze,
    Italy

    Active - Recruiting

  • Ospedale Versilia USL NORDOVEST Toscana - UOS Ematologia

    Lido Di Camaiore,
    Italy

    Active - Recruiting

  • Ospedale di Livorno - Ematologia

    Livorno,
    Italy

    Active - Recruiting

  • AOU G. Martino - U.O.C. Ematologia

    Messina,
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia

    Milano,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia

    Milano,
    Italy

    Active - Recruiting

  • Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia

    Milano,
    Italy

    Active - Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori - Ematologia

    Monza,
    Italy

    Active - Recruiting

  • AOU Federico II - Ematologia

    Napoli,
    Italy

    Site Not Available

  • AOU Maggiore della Carità di Novara - SCDU Ematologia

    Novara,
    Italy

    Active - Recruiting

  • I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1

    Padova,
    Italy

    Active - Recruiting

  • Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia

    Pagani,
    Italy

    Site Not Available

  • A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia

    Palermo,
    Italy

    Site Not Available

  • IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia

    Pavia,
    Italy

    Site Not Available

  • P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi

    Pescara,
    Italy

    Site Not Available

  • Ospedale Guglielmo da Saliceto - U.O. Ematologia

    Piacenza,
    Italy

    Active - Recruiting

  • A.O.R. "San Carlo" - U.O. Ematologia

    Potenza,
    Italy

    Site Not Available

  • Ospedale delle Croci - Ematologia

    Ravenna,
    Italy

    Active - Recruiting

  • Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia

    Reggio Calabria,
    Italy

    Site Not Available

  • Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia

    Reggio Emilia,
    Italy

    Active - Recruiting

  • IRCCS-Centro di Riferimento Oncologico - UO di ematologia e Trapianto Cellule Staminali

    Rionero In Vulture,
    Italy

    Site Not Available

  • AO Sant' Andrea - Ematologia

    Roma,
    Italy

    Active - Recruiting

  • Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione

    Roma,
    Italy

    Site Not Available

  • Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare

    Roma,
    Italy

    Site Not Available

  • Istituto Clinico Humanitas - U.O. Ematologia

    Rozzano,
    Italy

    Active - Recruiting

  • AOU di Sassari - Ematologia

    Sassari,
    Italy

    Site Not Available

  • Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico

    Sassuolo,
    Italy

    Site Not Available

  • AOU Senese - U.O.C. Ematologia

    Siena,
    Italy

    Site Not Available

  • Ospedale "G. Mazzini" - UOS Ematologia

    Teramo,
    Italy

    Site Not Available

  • A.O. S. Maria di Terni - S.C. Oncoematologia

    Terni,
    Italy

    Site Not Available

  • A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria

    Torino,
    Italy

    Active - Recruiting

  • A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia

    Torino,
    Italy

    Active - Recruiting

  • Ospedale Ca' Foncello - S.C di Ematologia

    Treviso,
    Italy

    Active - Recruiting

  • A.O. C. Panico - U.O.C Ematologia e Trapianto

    Tricase,
    Italy

    Site Not Available

  • Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia

    Trieste,
    Italy

    Active - Recruiting

  • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica

    Udine,
    Italy

    Site Not Available

  • AOU Integrata di Verona - U.O. Ematologia

    Verona,
    Italy

    Active - Recruiting

  • ULSS 8 Berica - Ospedale S. Bortolo - Ematologia

    Vicenza,
    Italy

    Active - Recruiting

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