Evaluating the impact of new monoclonal antibodies in treating B-cell Non-Hodgkin Lymphoma in Italy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational cohort study aims to assess the clinical impact of novel monoclonal antibodies (MAB) on patients with B-cell Non-Hodgkin Lymphoma (NHL) in Italy. It will collect data on the use, feasibility, efficacy, and toxicity of these MABs that have been approved by the EMA since 2020. Patients will be grouped based on treatment indications, type of antibody, and histological subtype, allowing for detailed analyses of outcomes. The study will provide insights into both short- and long-term effects of these treatments in real-world clinical practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ospedale SS. Cosma e Damiano - Ospedale San Jacopo - SOS Oncoematologia ed ematologia clinica
  Pescia, Pistoia, Italy Recruiting
• A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia
  Alessandria, Italy Recruiting
• AOU Ospedali Riuniti - Clinica di Ematologia
  Ancona, Italy Recruiting
• Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
  Avellino, Italy Recruiting
• IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
  Aviano, Italy Recruiting
• IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia
  Bari, Italy Recruiting

+11 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Marco Ladetto, Prof. — AO SS Antonio e Biagio e Cesare Arrigo, Alessandria
• Study coordinator: Uffici Studi FIL
• Email: startup@filinf.it
• Phone: +390131033153

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.