Clinical trial NCT06008691: A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice
Official title: 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 type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-Hodgkin Lymphoma, B-cell
Keywords: Non-Hodgkin Lymphoma
B-cell
monoclonal antibodies
novel antibodies
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2023-08-23
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: At least 5 years
measure: Complete Response rate (CRR)
timeFrame: At least 5 years
measure: Progression free survival (PFS)
timeFrame: At least 5 years
measure: Overall survival (OS)
timeFrame: At least 5 years
measure: Event free survival (EFS)
timeFrame: At least 5 years
measure: Time-to-next treatment (TTNT)
timeFrame: At least 5 years
measure: non-relapse mortality (NRM)
timeFrame: At least 5 years
measure: Duration of response (DOR)
timeFrame: At least 5 years
measure: Incidence of Early/Late Adverse Events
timeFrame: At least 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Viagrande
country: Italy
facility: Istituto Oncologico del Mediterraneo SPA - Oncologico
state: Catania
city: Pescia
country: Italy
facility: Ospedale SS. Cosma e Damiano - Ospedale San Jacopo - SOS Oncoematologia ed ematologia clinica
state: Pistoia
city: Alessandria
country: Italy
facility: A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti - Clinica di Ematologia
city: Avellino
country: Italy
facility: Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
city: Aviano
country: Italy
facility: IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
city: Bari
country: Italy
facility: IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia
city: Barletta
country: Italy
facility: Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII - Ematologia
city: Biella
country: Italy
facility: Nuovo Ospedale degli Infermi - SSD Ematologia
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Seragnoli"
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia - Ematologia
city: Cagliari
country: Italy
facility: Ospedale Businco - SC Ematologia e CTMO
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia - IRCCS - Ematologia
city: Carrara
country: Italy
facility: Osp. civile di Carrara - Oncologia Medica
city: Castelfranco Veneto
country: Italy
facility: Ospedale di Castelfranco Veneto - Ematologia
city: Catania
country: Italy
facility: Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
city: Catania
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia
city: Civitanova Marche
country: Italy
facility: Ospedale di Civitanova Marche - UOSD EMATOLOGIA AREA VASTA 3 MACERATA
city: Cuneo
country: Italy
facility: A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
city: Lido Di Camaiore
country: Italy
facility: Ospedale Versilia USL NORDOVEST Toscana - UOS Ematologia
city: Livorno
country: Italy
facility: Ospedale di Livorno - Ematologia
city: Messina
country: Italy
facility: AOU G. Martino - U.O.C. Ematologia
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
city: Milano
country: Italy
facility: Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori - Ematologia
city: Napoli
country: Italy
facility: AOU Federico II - Ematologia
city: Novara
country: Italy
facility: AOU Maggiore della Carità di Novara - SCDU Ematologia
city: Padova
country: Italy
facility: I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
city: Pagani
country: Italy
facility: Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
city: Palermo
country: Italy
facility: A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
city: Pavia
country: Italy
facility: IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
city: Pescara
country: Italy
facility: P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
city: Piacenza
country: Italy
facility: Ospedale Guglielmo da Saliceto - U.O. Ematologia
city: Potenza
country: Italy
facility: A.O.R. "San Carlo" - U.O. Ematologia
city: Ravenna
country: Italy
facility: Ospedale delle Croci - Ematologia
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia
city: Reggio Emilia
country: Italy
facility: Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
city: Rionero In Vulture
country: Italy
facility: IRCCS-Centro di Riferimento Oncologico - UO di ematologia e Trapianto Cellule Staminali
city: Roma
country: Italy
facility: AO Sant' Andrea - Ematologia
city: Roma
country: Italy
facility: Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas - U.O. Ematologia
city: Sassari
country: Italy
facility: AOU di Sassari - Ematologia
city: Sassuolo
country: Italy
facility: Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
city: Siena
country: Italy
facility: AOU Senese - U.O.C. Ematologia
city: Teramo
country: Italy
facility: Ospedale "G. Mazzini" - UOS Ematologia
city: Terni
country: Italy
facility: A.O. S. Maria di Terni - S.C. Oncoematologia
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
city: Treviso
country: Italy
facility: Ospedale Ca' Foncello - S.C di Ematologia
city: Tricase
country: Italy
facility: A.O. C. Panico - U.O.C Ematologia e Trapianto
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica
city: Verona
country: Italy
facility: AOU Integrata di Verona - U.O. Ematologia
city: Vicenza
country: Italy
facility: ULSS 8 Berica - Ospedale S. Bortolo - Ematologia
Study officials:
affiliation: AO SS Antonio e Biagio e Cesare Arrigo, Alessandria
name: Marco Ladetto, Prof.
role: PRINCIPAL_INVESTIGATOR
References: