Actively Recruiting
A Prospective, Observational Cohort Study to Evaluate the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice
Led by Fondazione Italiana Linfomi - ETS · Updated on 2025-12-29
1500
Participants Needed
61
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Fondazione Italiana Linfomi - ETS
Lead Sponsor
R
Roche Pharma AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a large prospective, observational cohort study to evaluate the clinical impact of new Monoclonal Antibodies (MAB) in patients with B-cell Non-Hodgkin Lymphoma (NHL) treated in Italian clinical practice. The study focuses on collecting information about the use, feasibility, effectiveness, and both short- and long-term side effects of novel MABs that have been approved by the European Medicines Agency since 2020 and prescribed according to authorized indications in Italy. Participants will be divided into groups based on treatment indication, antibody type, and lymphoma subtype to allow detailed analysis. The study observes patients with B-cell NHL who have received at least one dose of a novel MAB either alone or in combination, as authorized for use in Italy. Both patients receiving first-line treatment and those with relapsed or refractory disease are included. Various cohorts and sub-cohorts will be analyzed to understand outcomes by indication, antibody type, and histological subtype, providing a comprehensive overview of these treatments in real-life settings. Participants will be followed for at least five years to assess outcomes such as overall response rate, complete response rate, progression-free survival, overall survival, event-free survival, time to next treatment, non-relapse mortality, duration of response, and the incidence of early and late adverse events. Clinical data collection will include treatment details, safety monitoring, and long-term follow-up to evaluate both effectiveness and toxicity. The study spans several years, allowing researchers to capture extensive real-world evidence on novel MAB use in B-cell NHL.
CONDITIONS
Brief Title
A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with B-cell Non-Hodgkin Lymphoma requiring treatment according to guideline indications, including first-line and relapsed or refractory cases
- Planned treatment with a novel Monoclonal Antibody approved by EMA since 2020 and prescribed according to authorized indications in Italy
- Signed written informed consent
You will not qualify if you...
- Participation in any prospective interventional clinical trial outside approved indications
- Treatment outside approved indications, including compassionate use or unsupported indications
- Age under 18 years
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 5 years
Participants treated with novel monoclonal antibodies are observed to collect clinical information on use, feasibility, efficacy, and toxicity over time.
Regular visits as per clinical practice
Trial Site Locations
Total: 61 locations
1
Istituto Oncologico del Mediterraneo SPA - Oncologico
Viagrande, Catania, Italy
Not Yet Recruiting
2
Ospedale SS. Cosma e Damiano - Ospedale San Jacopo - SOS Oncoematologia ed ematologia clinica
Pescia, Pistoia, Italy
Actively Recruiting
3
A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia
Alessandria, Italy
Actively Recruiting
4
AOU Ospedali Riuniti - Clinica di Ematologia
Ancona, Italy
Actively Recruiting
5
Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Avellino, Italy
Actively Recruiting
6
IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
Aviano, Italy
Actively Recruiting
7
IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia
Bari, Italy
Actively Recruiting
8
Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
Barletta, Italy
Not Yet Recruiting
9
Azienda Ospedaliera Papa Giovanni XXIII - Ematologia
Bergamo, Italy
Actively Recruiting
10
Nuovo Ospedale degli Infermi - SSD Ematologia
Biella, Italy
Actively Recruiting
11
Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Seragnoli"
Bologna, Italy
Actively Recruiting
12
ASST Spedali Civili di Brescia - Ematologia
Brescia, Italy
Actively Recruiting
13
Ospedale Businco - SC Ematologia e CTMO
Cagliari, Italy
Not Yet Recruiting
14
Fondazione del Piemonte per l'Oncologia - IRCCS - Ematologia
Candiolo, Italy
Actively Recruiting
15
Osp. civile di Carrara - Oncologia Medica
Carrara, Italy
Actively Recruiting
16
Ospedale di Castelfranco Veneto - Ematologia
Castelfranco Veneto, Italy
Actively Recruiting
17
Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
Catania, Italy
Actively Recruiting
18
Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia
Catania, Italy
Actively Recruiting
19
Ospedale di Civitanova Marche - UOSD EMATOLOGIA AREA VASTA 3 MACERATA
Civitanova Marche, Italy
Actively Recruiting
20
ASST Cremona - Ematologia e CRTO
Cremona, Italy
Actively Recruiting
21
A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo
Cuneo, Italy
Actively Recruiting
22
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
Florence, Italy
Actively Recruiting
23
Presidio Ospedaliero F. Spaziani - UOC Ematologia
Frosinone, Italy
Actively Recruiting
24
Ospedale Versilia USL NORDOVEST Toscana - UOS Ematologia
Lido di Camaiore, Italy
Actively Recruiting
25
Ospedale di Livorno - Ematologia
Livorno, Italy
Actively Recruiting
26
Ospedale Apuane - Oncoematologia
Massa, Italy
Actively Recruiting
27
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan, Italy
Actively Recruiting
28
ASST Santi Paolo e Carlo - Onco - Ematologia
Milan, Italy
Actively Recruiting
29
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
Milan, Italy
Actively Recruiting
30
Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia
Milan, Italy
Actively Recruiting
31
Fondazione IRCCS San Gerardo dei Tintori - Ematologia
Monza, Italy
Actively Recruiting
32
AOU Federico II - Ematologia
Naples, Italy
Not Yet Recruiting
33
AOU Maggiore della Carità di Novara - SCDU Ematologia
Novara, Italy
Actively Recruiting
34
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
Padova, Italy
Actively Recruiting
35
Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
Pagani, Italy
Not Yet Recruiting
36
A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
Palermo, Italy
Not Yet Recruiting
37
IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
Pavia, Italy
Not Yet Recruiting
38
P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
Pescara, Italy
Actively Recruiting
39
Ospedale Guglielmo da Saliceto - U.O. Ematologia
Piacenza, Italy
Actively Recruiting
40
A.O.R. "San Carlo" - U.O. Ematologia
Potenza, Italy
Not Yet Recruiting
41
Ospedale S.Stefano SOS Oncoematologia
Prato, Italy
Actively Recruiting
42
Ospedale delle Croci - Ematologia
Ravenna, Italy
Actively Recruiting
43
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Reggio Emilia, Italy
Actively Recruiting
44
IRCCS-Centro di Riferimento Oncologico - UO di ematologia e Trapianto Cellule Staminali
Rionero in Vulture, Italy
Actively Recruiting
45
AO Sant' Andrea - Ematologia
Roma, Italy
Actively Recruiting
46
Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
Roma, Italy
Actively Recruiting
47
Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
Roma, Italy
Actively Recruiting
48
Istituto Clinico Humanitas - U.O. Ematologia
Rozzano, Italy
Actively Recruiting
49
AOU di Sassari - Ematologia
Sassari, Italy
Not Yet Recruiting
50
Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
Sassuolo, Italy
Actively Recruiting
51
AOU Senese - U.O.C. Ematologia
Siena, Italy
Actively Recruiting
52
Ospedale "G. Mazzini" - UOS Ematologia
Teramo, Italy
Not Yet Recruiting
53
A.O. S. Maria di Terni - S.C. Oncoematologia
Terni, Italy
Not Yet Recruiting
54
A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria
Torino, Italy
Actively Recruiting
55
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
Torino, Italy
Actively Recruiting
56
Ospedale Ca' Foncello - S.C di Ematologia
Treviso, Italy
Actively Recruiting
57
A.O. C. Panico - U.O.C Ematologia e Trapianto
Tricase, Italy
Actively Recruiting
58
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia
Trieste, Italy
Actively Recruiting
59
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica
Udine, Italy
Actively Recruiting
60
AOU Integrata di Verona - U.O. Ematologia
Verona, Italy
Actively Recruiting
61
ULSS 8 Berica - Ospedale S. Bortolo - Ematologia
Vicenza, Italy
Actively Recruiting
Research Team
U
Uffici Studi FIL
U
Uffici Studi FIL
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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