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
1 other identifier
observational
1,500
1 country
61
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2023
Longer than P75 for all trials
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2023
CompletedFirst Posted
Study publicly available on registry
August 23, 2023
CompletedStudy Start
First participant enrolled
December 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2038
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2038
December 29, 2025
December 1, 2025
14.8 years
August 11, 2023
December 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Overall response rate (ORR)
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)
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)
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)
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)
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)
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)
NRM is defined as death without recurrent or progressive disease after treatment.
At least 5 years
Duration of response (DOR)
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
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
Study Arms (1)
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.
Interventions
"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
Eligibility Criteria
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.
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:
- approved indication.
- % AIFA support.
- Compassionate use.
- Age less than 18 years.
- Inability to provide an informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondazione Italiana Linfomi - ETSlead
- Roche Pharma AGcollaborator
Study Sites (61)
Istituto Oncologico del Mediterraneo SPA - Oncologico
Viagrande, Catania, Italy
Ospedale SS. Cosma e Damiano - Ospedale San Jacopo - SOS Oncoematologia ed ematologia clinica
Pescia, Pistoia, Italy
A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia
Alessandria, Italy
AOU Ospedali Riuniti - Clinica di Ematologia
Ancona, Italy
Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Avellino, Italy
IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
Aviano, Italy
IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia
Bari, Italy
Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
Barletta, Italy
Azienda Ospedaliera Papa Giovanni XXIII - Ematologia
Bergamo, Italy
Nuovo Ospedale degli Infermi - SSD Ematologia
Biella, Italy
Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Seragnoli"
Bologna, Italy
ASST Spedali Civili di Brescia - Ematologia
Brescia, Italy
Ospedale Businco - SC Ematologia e CTMO
Cagliari, Italy
Fondazione del Piemonte per l'Oncologia - IRCCS - Ematologia
Candiolo, Italy
Osp. civile di Carrara - Oncologia Medica
Carrara, Italy
Ospedale di Castelfranco Veneto - Ematologia
Castelfranco Veneto, Italy
Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
Catania, Italy
Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia
Catania, Italy
Ospedale di Civitanova Marche - UOSD EMATOLOGIA AREA VASTA 3 MACERATA
Civitanova Marche, Italy
ASST Cremona - Ematologia e CRTO
Cremona, Italy
A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo
Cuneo, Italy
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
Florence, Italy
Presidio Ospedaliero F. Spaziani - UOC Ematologia
Frosinone, Italy
Ospedale Versilia USL NORDOVEST Toscana - UOS Ematologia
Lido di Camaiore, Italy
Ospedale di Livorno - Ematologia
Livorno, Italy
Ospedale Apuane - Oncoematologia
Massa, Italy
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan, Italy
ASST Santi Paolo e Carlo - Onco - Ematologia
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
Milan, Italy
Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia
Milan, Italy
Fondazione IRCCS San Gerardo dei Tintori - Ematologia
Monza, Italy
AOU Federico II - Ematologia
Naples, Italy
AOU Maggiore della Carità di Novara - SCDU Ematologia
Novara, Italy
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
Padua, Italy
Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
Pagani, Italy
A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
Palermo, Italy
IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
Pavia, Italy
P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
Pescara, Italy
Ospedale Guglielmo da Saliceto - U.O. Ematologia
Piacenza, Italy
A.O.R. "San Carlo" - U.O. Ematologia
Potenza, Italy
Ospedale S.Stefano SOS Oncoematologia
Prato, Italy
Ospedale delle Croci - Ematologia
Ravenna, Italy
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Reggio Emilia, Italy
IRCCS-Centro di Riferimento Oncologico - UO di ematologia e Trapianto Cellule Staminali
Rionero in Vulture, Italy
AO Sant' Andrea - Ematologia
Roma, Italy
Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
Roma, Italy
Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
Roma, Italy
Istituto Clinico Humanitas - U.O. Ematologia
Rozzano, Italy
AOU di Sassari - Ematologia
Sassari, Italy
Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
Sassuolo, Italy
AOU Senese - U.O.C. Ematologia
Siena, Italy
Ospedale "G. Mazzini" - UOS Ematologia
Teramo, Italy
A.O. S. Maria di Terni - S.C. Oncoematologia
Terni, Italy
A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria
Torino, Italy
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
Torino, Italy
Ospedale Ca' Foncello - S.C di Ematologia
Treviso, Italy
A.O. C. Panico - U.O.C Ematologia e Trapianto
Tricase, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia
Trieste, Italy
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica
Udine, Italy
AOU Integrata di Verona - U.O. Ematologia
Verona, Italy
ULSS 8 Berica - Ospedale S. Bortolo - Ematologia
Vicenza, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marco Ladetto, Prof.
AO SS Antonio e Biagio e Cesare Arrigo, Alessandria
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2023
First Posted
August 23, 2023
Study Start
December 27, 2023
Primary Completion (Estimated)
October 1, 2038
Study Completion (Estimated)
October 1, 2038
Last Updated
December 29, 2025
Record last verified: 2025-12