Trial Title:
A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice
NCT ID:
NCT06008691
Condition:
Non-Hodgkin Lymphoma, B-cell
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Conditions: Keywords:
Non-Hodgkin Lymphoma
B-cell
monoclonal antibodies
novel antibodies
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
"novel" MAB (alone or in combination)
Description:
"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
Arm group label:
B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA and AIFA).
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Istituto Oncologico del Mediterraneo SPA - Oncologico
Address:
City:
Viagrande
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Giulio Antonio Milone, MD
Email:
giulio.milone89@gmail.com
Facility:
Name:
Ospedale SS. Cosma e Damiano - Ospedale San Jacopo - SOS Oncoematologia ed ematologia clinica
Address:
City:
Pescia
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Roberta Giachetti, MD
Email:
roberta.giachetti@uslcentro.toscana.it
Facility:
Name:
A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia
Address:
City:
Alessandria
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Marco Ladetto, Prof.
Email:
marco.ladetto@ospedale.al.it
Facility:
Name:
AOU Ospedali Riuniti - Clinica di Ematologia
Address:
City:
Ancona
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Guido Gini, MD
Email:
guido.gini@ospedaliriuniti.marche.it
Facility:
Name:
Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Address:
City:
Avellino
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Sonya De Lorenzo, MD
Email:
sonya.delorenzo@tin.it
Facility:
Name:
IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
Address:
City:
Aviano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Michele Spina, MD
Email:
mspina@cro.it
Facility:
Name:
IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia
Address:
City:
Bari
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Giacomo Loseto, MD
Email:
loseto.giacomo@gmail.com
Facility:
Name:
Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
Address:
City:
Barletta
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Giuseppe Tarantini, MD
Email:
giuseppetarantini0@gmail.com
Facility:
Name:
Azienda Ospedaliera Papa Giovanni XXIII - Ematologia
Address:
City:
Bergamo
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Alessandro Rambaldi, MD
Email:
arambaldi@asst-pg23.it
Facility:
Name:
Nuovo Ospedale degli Infermi - SSD Ematologia
Address:
City:
Biella
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Annarita Conconi, MD
Email:
annarita.conconi@aslbi.piemonte.it
Facility:
Name:
Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Seragnoli"
Address:
City:
Bologna
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Beatrice Casadei, MD
Email:
beatrice.casadei10@unibo.it
Facility:
Name:
ASST Spedali Civili di Brescia - Ematologia
Address:
City:
Brescia
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Alessandro Re, MD
Email:
alessandro.re@asst-spedalicivili.it
Facility:
Name:
Ospedale Businco - SC Ematologia e CTMO
Address:
City:
Cagliari
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Maria Pina Simula, MD
Email:
mariap.simula@aob.it
Facility:
Name:
Fondazione del Piemonte per l'Oncologia - IRCCS - Ematologia
Address:
City:
Candiolo
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Pio Manlio Mirko Frascione, MD
Email:
piomanliomirko.frascione@ircc.it
Facility:
Name:
Osp. civile di Carrara - Oncologia Medica
Address:
City:
Carrara
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Roberta Della Seta, MD
Email:
rdellaseta@alice.it
Facility:
Name:
Ospedale di Castelfranco Veneto - Ematologia
Address:
City:
Castelfranco Veneto
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Mariella Lo Schirico, MD
Email:
mariella.loschirico@iov.veneto.it
Facility:
Name:
Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
Address:
City:
Catania
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Ugo Consoli, MD
Email:
ugo.consoli144@gmail.com
Facility:
Name:
Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia
Address:
City:
Catania
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Annalisa Chiarenza, MD
Email:
annalisa.chiarenza@gmail.com
Facility:
Name:
Ospedale di Civitanova Marche - UOSD EMATOLOGIA AREA VASTA 3 MACERATA
Address:
City:
Civitanova Marche
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Caterina Bocci, MD
Email:
cate.bocci@gmail.com
Facility:
Name:
A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo
Address:
City:
Cuneo
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alessia Castellino, MD
Email:
castellino.ale@ospedale.cuneo.it
Facility:
Name:
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
Address:
City:
Firenze
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Luca Nassi, MD
Email:
nassil@aou-careggi.toscana.it
Facility:
Name:
Ospedale Versilia USL NORDOVEST Toscana - UOS Ematologia
Address:
City:
Lido Di Camaiore
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Federico Simonetti, MD
Email:
federico.simonetti@uslnordovest.toscana.it
Facility:
Name:
Ospedale di Livorno - Ematologia
Address:
City:
Livorno
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Sofya Kovalchuk, MD
Email:
sofya.kova82@gmail.com
Facility:
Name:
AOU G. Martino - U.O.C. Ematologia
Address:
City:
Messina
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Alessandro Allegra, MD
Email:
alessandro.allegra@unime.it
Facility:
Name:
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Address:
City:
Milano
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Vittorio Ruggero Zilioli, MD
Email:
vittorioruggero.zilioli@ospedaleniguarda.it
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
Address:
City:
Milano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Paolo Corradini, Prof.
Email:
paolo.corradini@unimi.it
Facility:
Name:
Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia
Address:
City:
Milano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Andrès Ferreri, MD
Email:
andres.ferreri@hsr.it
Facility:
Name:
Fondazione IRCCS San Gerardo dei Tintori - Ematologia
Address:
City:
Monza
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Federica Cocito, MD
Email:
cocitofederica@gmail.com
Facility:
Name:
AOU Federico II - Ematologia
Address:
City:
Napoli
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Fabrizio Pane, Prof.
Email:
fabrizio.pane@unina.it
Facility:
Name:
AOU Maggiore della Carità di Novara - SCDU Ematologia
Address:
City:
Novara
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Riccardo Bruna, MD
Email:
riccardo.bruna@med.uniupo.it
Facility:
Name:
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
Address:
City:
Padova
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Dario Marino, MD
Email:
dario.marino@iov.veneto.it
Facility:
Name:
Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
Address:
City:
Pagani
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Catello Califano, MD
Email:
c.califano@aslsalerno.it
Facility:
Name:
A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
Address:
City:
Palermo
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Caterina Patti, MD
Email:
k.patti@villasofia.it
Facility:
Name:
IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
Address:
City:
Pavia
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Luca Arcaini, Prof.
Email:
luca.arcaini@unipv.it
Facility:
Name:
P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
Address:
City:
Pescara
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Elsa Pennese, MD
Email:
elsa.pennese@asl.pe.it
Facility:
Name:
Ospedale Guglielmo da Saliceto - U.O. Ematologia
Address:
City:
Piacenza
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Annalisa Arcari, MD
Email:
a.arcari@ausl.pc.it
Facility:
Name:
A.O.R. "San Carlo" - U.O. Ematologia
Address:
City:
Potenza
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Michele Cimminiello, MD
Email:
miki-doc@virgilio.it
Facility:
Name:
Ospedale delle Croci - Ematologia
Address:
City:
Ravenna
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Monica Tani, MD
Email:
monica.tani@auslromagna.it
Facility:
Name:
Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia
Address:
City:
Reggio Calabria
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Caterina Stelitano, MD
Email:
caterinastelitano27@gmail.com
Facility:
Name:
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Address:
City:
Reggio Emilia
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Stefano Luminari, Prof.
Email:
stefano.luminari@ausl.re.it
Facility:
Name:
IRCCS-Centro di Riferimento Oncologico - UO di ematologia e Trapianto Cellule Staminali
Address:
City:
Rionero In Vulture
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Giuseppe Pietrantuono, MD
Email:
ematologia45@alice.it
Facility:
Name:
AO Sant' Andrea - Ematologia
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Agostino Tafuri, Prof.
Email:
agostino.tafuri@ospedalesantandrea.it
Facility:
Name:
Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Alice Di Rocco, MD
Email:
dirocco@bce.uniroma1.it
Facility:
Name:
Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Luigi Rigacci, MD
Email:
l.rigacci@policlinicocampus.it
Facility:
Name:
Istituto Clinico Humanitas - U.O. Ematologia
Address:
City:
Rozzano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Monica Balzarotti, MD
Email:
monica.balzarotti@humanitas.it
Facility:
Name:
AOU di Sassari - Ematologia
Address:
City:
Sassari
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Claudio Fozza, Prof.
Email:
cfozza@uniss.it
Facility:
Name:
Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
Address:
City:
Sassuolo
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Sara Bigliardi, MD
Email:
s.bigliardi@ausl.mo.it
Facility:
Name:
AOU Senese - U.O.C. Ematologia
Address:
City:
Siena
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Alberto Fabbri, MD
Email:
fabbri7@unisi.it
Facility:
Name:
Ospedale "G. Mazzini" - UOS Ematologia
Address:
City:
Teramo
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Angelo Fama, MD
Email:
angelo.fama@aslteramo.it
Facility:
Name:
A.O. S. Maria di Terni - S.C. Oncoematologia
Address:
City:
Terni
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Anna Marina Liberati, Prof.
Email:
marina.liberati@unipg.it
Facility:
Name:
A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria
Address:
City:
Torino
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Federica Cavallo, MD
Email:
f.cavallo@unito.it
Facility:
Name:
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
Address:
City:
Torino
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Maura Nicolosi, MD
Email:
manicolosi@cittadellasalute.to.it
Facility:
Name:
Ospedale Ca' Foncello - S.C di Ematologia
Address:
City:
Treviso
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Elisabetta Scarpa, MD
Email:
elisabetta.scarpa@aulss2.veneto.it
Facility:
Name:
A.O. C. Panico - U.O.C Ematologia e Trapianto
Address:
City:
Tricase
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Vincenzo Pavone, MD
Email:
salentoematologia@piafondazionepanico.it
Facility:
Name:
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia
Address:
City:
Trieste
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Francesco Zaja, Prof.
Email:
francesco.zaja@asugi.sanita.fvg.it
Facility:
Name:
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica
Address:
City:
Udine
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Jacopo Olivieri, MD
Email:
jacopo.olivieri@asufc.sanita.fvg.it
Facility:
Name:
AOU Integrata di Verona - U.O. Ematologia
Address:
City:
Verona
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Carlo Visco, Prof.
Email:
carlo.visco@univr.it
Facility:
Name:
ULSS 8 Berica - Ospedale S. Bortolo - Ematologia
Address:
City:
Vicenza
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Maria Chiara Tisi, MD
Email:
mariachiara.tisi@aulss8.veneto.it
Start date:
December 27, 2023
Completion date:
October 2038
Lead sponsor:
Agency:
Fondazione Italiana Linfomi - ETS
Agency class:
Other
Collaborator:
Agency:
Roche Pharma AG
Agency class:
Industry
Source:
Fondazione Italiana Linfomi - ETS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06008691
