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
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2023-12-27
2038-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
"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
Interventions
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"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
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients treated outside approved indications:
* 648-approved indication.
* 5% AIFA support.
* Compassionate use.
* Age less than 18 years.
* Inability to provide an informed consent.
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Fondazione Italiana Linfomi - ETS
OTHER
Responsible Party
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Principal Investigators
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Marco Ladetto, Prof.
Role: PRINCIPAL_INVESTIGATOR
AO SS Antonio e Biagio e Cesare Arrigo, Alessandria
Locations
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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
Napoli, , 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
Countries
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Central Contacts
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Facility Contacts
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Giulio Antonio Milone, MD
Role: primary
Roberta Giachetti, MD
Role: primary
Marco Ladetto, Prof.
Role: primary
Guido Gini, MD
Role: primary
Sonya De Lorenzo, MD
Role: primary
Michele Spina, MD
Role: primary
Giacomo Loseto, MD
Role: primary
Giuseppe Tarantini, MD
Role: primary
Alessandro Rambaldi, MD
Role: primary
Annarita Conconi, MD
Role: primary
Beatrice Casadei, MD
Role: primary
Alessandro Re, MD
Role: primary
Maria Pina Simula, MD
Role: primary
Pio Manlio Mirko Frascione, MD
Role: primary
Roberta Della Seta, MD
Role: primary
Mariella Lo Schirico, MD
Role: primary
Ugo Consoli, MD
Role: primary
Annalisa Chiarenza, MD
Role: primary
Caterina Bocci, MD
Role: primary
Alfredo Molteni, MD
Role: primary
Alessia Castellino, MD
Role: primary
Luca Nassi, MD
Role: primary
Antonella Ferrari, MD
Role: primary
Federico Simonetti, MD
Role: primary
Sofya Kovalchuk, MD
Role: primary
Roberta Della Seta, MD
Role: primary
Vittorio Ruggero Zilioli, MD
Role: primary
Vittorio Montefusco, MD
Role: primary
Paolo Corradini, Prof.
Role: primary
Andrès Ferreri, MD
Role: primary
Federica Cocito, MD
Role: primary
Fabrizio Pane, Prof.
Role: primary
Riccardo Bruna, MD
Role: primary
Dario Marino, MD
Role: primary
Catello Califano, MD
Role: primary
Caterina Patti, MD
Role: primary
Luca Arcaini, Prof.
Role: primary
Elsa Pennese, MD
Role: primary
Annalisa Arcari, MD
Role: primary
Michele Cimminiello, MD
Role: primary
Lara Mannelli, MD
Role: primary
Monica Tani, MD
Role: primary
Stefano Luminari, Prof.
Role: primary
Giuseppe Pietrantuono, MD
Role: primary
Agostino Tafuri, Prof.
Role: primary
Alice Di Rocco, MD
Role: primary
Luigi Rigacci, MD
Role: primary
Monica Balzarotti, MD
Role: primary
Claudio Fozza, Prof.
Role: primary
Sara Bigliardi, MD
Role: primary
Alberto Fabbri, MD
Role: primary
Angelo Fama, MD
Role: primary
Anna Marina Liberati, Prof.
Role: primary
Federica Cavallo, MD
Role: primary
Maura Nicolosi, MD
Role: primary
Elisabetta Scarpa, MD
Role: primary
Vincenzo Pavone, MD
Role: primary
Francesco Zaja, Prof.
Role: primary
Jacopo Olivieri, MD
Role: primary
Carlo Visco, Prof.
Role: primary
Maria Chiara Tisi, MD
Role: primary
Other Identifiers
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FIL_MAB
Identifier Type: -
Identifier Source: org_study_id