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

December 22, 2025 updated by: Fondazione Italiana Linfomi - ETS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Alessandria, Italy
      • Ancona, Italy
      • Avellino, Italy
        • Recruiting
        • Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
        • Contact:
      • Aviano, Italy
        • Recruiting
        • IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
        • Contact:
      • Bari, Italy
        • Recruiting
        • IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia
        • Contact:
      • Barletta, Italy
        • Not yet recruiting
        • Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
        • Contact:
      • Bergamo, Italy
        • Recruiting
        • Azienda Ospedaliera Papa Giovanni XXIII - Ematologia
        • Contact:
      • Biella, Italy
      • Bologna, Italy
        • Recruiting
        • Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Seragnoli"
        • Contact:
      • Brescia, Italy
      • Cagliari, Italy
        • Not yet recruiting
        • Ospedale Businco - SC Ematologia e CTMO
        • Contact:
      • Candiolo, Italy
      • Carrara, Italy
        • Recruiting
        • Osp. civile di Carrara - Oncologia Medica
        • Contact:
      • Castelfranco Veneto, Italy
      • Catania, Italy
        • Recruiting
        • Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
        • Contact:
      • Catania, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia
        • Contact:
      • Civitanova Marche, Italy
        • Recruiting
        • Ospedale di Civitanova Marche - UOSD EMATOLOGIA AREA VASTA 3 MACERATA
        • Contact:
      • Cremona, Italy
      • Cuneo, Italy
      • Florence, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
        • Contact:
      • Frosinone, Italy
      • Lido di Camaiore, Italy
      • Livorno, Italy
      • Massa, Italy
        • Recruiting
        • Ospedale Apuane - Oncoematologia
        • Contact:
      • Milan, Italy
      • Milan, Italy
      • Milan, Italy
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
        • Contact:
      • Milan, Italy
        • Recruiting
        • Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia
        • Contact:
      • Monza, Italy
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori - Ematologia
        • Contact:
      • Napoli, Italy
      • Novara, Italy
      • Padua, Italy
      • Pagani, Italy
        • Not yet recruiting
        • Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
        • Contact:
      • Palermo, Italy
        • Not yet recruiting
        • A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
        • Contact:
      • Pavia, Italy
        • Not yet recruiting
        • IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
        • Contact:
      • Pescara, Italy
        • Recruiting
        • P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
        • Contact:
      • Piacenza, Italy
        • Recruiting
        • Ospedale Guglielmo da Saliceto - U.O. Ematologia
        • Contact:
      • Potenza, Italy
        • Not yet recruiting
        • A.O.R. "San Carlo" - U.O. Ematologia
        • Contact:
      • Prato, Italy
      • Ravenna, Italy
      • Reggio Emilia, Italy
        • Recruiting
        • Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
        • Contact:
      • Rionero in Vulture, Italy
        • Recruiting
        • IRCCS-Centro di Riferimento Oncologico - UO di ematologia e Trapianto Cellule Staminali
        • Contact:
      • Roma, Italy
        • Recruiting
        • Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
        • Contact:
      • Roma, Italy
      • Roma, Italy
        • Recruiting
        • Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
        • Contact:
      • Rozzano, Italy
      • Sassari, Italy
        • Not yet recruiting
        • AOU di Sassari - Ematologia
        • Contact:
      • Sassuolo, Italy
        • Recruiting
        • Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
        • Contact:
      • Siena, Italy
        • Recruiting
        • AOU Senese - U.O.C. Ematologia
        • Contact:
      • Teramo, Italy
      • Terni, Italy
        • Not yet recruiting
        • A.O. S. Maria di Terni - S.C. Oncoematologia
        • Contact:
      • Torino, Italy
        • Recruiting
        • A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
        • Contact:
      • Torino, Italy
      • Treviso, Italy
      • Tricase, Italy
      • Trieste, Italy
      • Udine, Italy
      • Verona, Italy
        • Recruiting
        • AOU Integrata di Verona - U.O. Ematologia
        • Contact:
      • Vicenza, Italy
    • Catania
      • Viagrande, Catania, Italy
        • Not yet recruiting
        • Istituto Oncologico del Mediterraneo SPA - Oncologico
        • Contact:
    • Pistoia
      • Pescia, Pistoia, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with diagnosis of B-cell NHL both first-line and relapsed or refractory 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA and AIFA).

B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA since 2020 and prescribed according to the indications for use authorized for marketing in Italy).

Patients first-line and relapsed or refractory who had received at least 1 dose of MAB.

Different cohorts will be analyzed according to approved treatment indications, type of antibody employed and NHL hystotypes.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: At least 5 years
ORR will be defined according to Lugano 2014 criteria as the proportion of patients who have a partial response (PR) or complete response to therapy (CR+PR).
At least 5 years
Complete Response rate (CRR)
Time Frame: At least 5 years
CRR will be defined according to Lugano 2014 criteria and will include only patients who achieved a CR at the end of treatment program. The best overall response will be defined as the best response between the date of beginning of therapy and the last restaging. Patients without response assessment (due to whatever reason) will be considered as non-responders.
At least 5 years
Progression free survival (PFS)
Time Frame: At least 5 years
PFS is defined as the time between the date of enrollment and the first documentation of recurrence, progression or death from any cause; responding patients and patients who are lost to follow up will be censored at their last assessment date.
At least 5 years
Overall survival (OS)
Time Frame: At least 5 years
OS is defined as the time between the start of treatment until death from any cause; patients who are lost at follow up will be censored at their last assessment date.
At least 5 years
Event free survival (EFS)
Time Frame: At least 5 years
ESFS is defined as the time from start of treatment to disease progression, death, or discontinuation of treatment for any reason (e.g. toxicity, patient preference), or initiation of a new treatment without documented progression.
At least 5 years
Time-to-next treatment (TTNT)
Time Frame: At least 5 years
TTNT represents the interval from commencement of one treatment to initiation of the next line of therapy.
At least 5 years
non-relapse mortality (NRM)
Time Frame: At least 5 years
NRM is defined as death without recurrent or progressive disease after treatment.
At least 5 years
Duration of response (DOR)
Time Frame: At least 5 years
DOR is defined as the time from the first documentation of tumor response (CR/PR) to disease progression or death according to Lugano 2014 criteria.
At least 5 years
Incidence of Early/Late Adverse Events
Time Frame: At least 5 years

Toxicities will be recorded and classified according to the definitions of the latest version of the NCI CTCAE. Toxicity events will be determined by the incidence of severe, life-threatening (CTCAE grade 3, 4 and 5) and/or serious adverse events (SAEs) commencing after the first induction dose or at any time during therapy. Early and toxic deaths and cause of any death. Special focus on second tumors, infections and autoimmune complications. Particularly:

  • Hematological and extra-hematological toxicities Grade > 2
  • Infusional adverse events, will be recorded any Grade
  • Toxicities of specific interest on second tumors, infections and autoimmune complications will be recorded any Grade
  • Early and toxic deaths and cause of any death.
At least 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi - ETS

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Marco Ladetto, Prof., AO SS Antonio e Biagio e Cesare Arrigo, Alessandria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2023

Primary Completion (Estimated)

October 1, 2038

Study Completion (Estimated)

October 1, 2038

Study Registration Dates

First Submitted

August 11, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_MAB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Hodgkin Lymphoma, B-cell

Clinical Trials on "novel" MAB (alone or in combination)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe