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

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

Observational Fondazione Italiana Linfomi - ETS · NCT06008691

This study is trying to see how well new monoclonal antibodies work for treating B-cell Non-Hodgkin Lymphoma patients in Italy and what side effects they might have.

Quick facts

Study typeObservational
Enrollment1500 (estimated)
Ages18 Years and up
SexAll
SponsorFondazione Italiana Linfomi - ETS Academic / other
Locations61 sites (Viagrande, Catania and 60 other locations)
Trial IDNCT06008691 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with B-cell NHL who require treatment and are eligible for novel monoclonal antibody therapies approved in Italy since 2020.

Not a fit: Patients under 18 years old or those involved in other interventional trials outside approved indications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance treatment strategies for patients with B-cell Non-Hodgkin Lymphoma by providing evidence on the effectiveness and safety of novel monoclonal antibodies.

How similar studies have performed: Other studies have shown promise in evaluating monoclonal antibodies for NHL, but this specific observational approach focusing on novel agents in Italian clinical practice is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Viagrande, Catania and 60 other locations

+11 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Hodgkin Lymphoma, B-cellNon-Hodgkin LymphomaB-cellmonoclonal antibodiesnovel antibodies
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.