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

Recruiting now

Conditions studied: Non-Hodgkin Lymphoma, B-cell

In brief

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.

Key facts

Study ID

NCT06008691

Run by

Fondazione Italiana Linfomi - ETS

People needed

1500

Starts

2023-12-27

Expected to finish

2038-10-01

Last updated by the study team

2025-12-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ospedale Apuane - Oncoematologia — Massa, Italy (enrolling)
• ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia — Milan, Italy (enrolling)
• Ospedale SS. Cosma e Damiano - Ospedale San Jacopo - SOS Oncoematologia ed ematologia clinica — Pescia, Pistoia, Italy (enrolling)
• Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico — Avellino, Italy (enrolling)
• A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia — Alessandria, Italy (enrolling)
• IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia — Bari, Italy (enrolling)
• AOU Ospedali Riuniti - Clinica di Ematologia — Ancona, Italy (enrolling)
• Azienda Ospedaliera Papa Giovanni XXIII - Ematologia — Bergamo, Italy (enrolling)
• Nuovo Ospedale degli Infermi - SSD Ematologia — Biella, Italy (enrolling)
• Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Seragnoli" — Bologna, Italy (enrolling)
• ASST Spedali Civili di Brescia - Ematologia — Brescia, Italy (enrolling)
• IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati — Aviano, Italy (enrolling)
• Fondazione del Piemonte per l'Oncologia - IRCCS - Ematologia — Candiolo, Italy (enrolling)
• Osp. civile di Carrara - Oncologia Medica — Carrara, Italy (enrolling)
• Ospedale di Castelfranco Veneto - Ematologia — Castelfranco Veneto, Italy (enrolling)
• Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia — Catania, Italy (enrolling)
• Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia — Catania, Italy (enrolling)
• Ospedale di Civitanova Marche - UOSD EMATOLOGIA AREA VASTA 3 MACERATA — Civitanova Marche, Italy (enrolling)
• ASST Cremona - Ematologia e CRTO — Cremona, Italy (enrolling)
• A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo — Cuneo, Italy (enrolling)
• Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia — Florence, Italy (enrolling)
• Presidio Ospedaliero F. Spaziani - UOC Ematologia — Frosinone, Italy (enrolling)
• Ospedale Versilia USL NORDOVEST Toscana - UOS Ematologia — Lido di Camaiore, Italy (enrolling)
• Ospedale di Livorno - Ematologia — Livorno, Italy (enrolling)
• ASST Santi Paolo e Carlo - Onco - Ematologia — Milan, Italy (enrolling)

Full record on ClinicalTrials.gov

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