A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice

Non-Hodgkin Lymphoma, B-cell Clinical Trial

— FIL_MAB  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06008691
• Other study ID #: FIL_MAB
• Status: Not yet recruiting
• Start date: October 2023
• Est. completion date: October 2038

Study information

• Verified date: August 2023
• Source: Fondazione Italiana Linfomi - ETS
• Contact: Uffici Studi FIL
• Phone: +390131033153
• Email: startup[@]filinf.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: October 2038
• Est. primary completion date: October 2038
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma, B-cell

Intervention

Drug:
• "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

Locations

Country	Name	City	State
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	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	Firenze
Italy	Ospedale Versilia USL NORDOVEST Toscana - UOS Ematologia	Lido Di Camaiore
Italy	Ospedale di Livorno - Ematologia	Livorno
Italy	AOU G. Martino - U.O.C. Ematologia	Messina
Italy	ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia	Milano
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia	Milano
Italy	Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia	Milano
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	Padova
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 SS. Cosma e Damiano - Ospedale San Jacopo - SOS Oncoematologia ed ematologia clinica	Pescia	Pistoia
Italy	Ospedale Guglielmo da Saliceto - U.O. Ematologia	Piacenza
Italy	A.O.R. "San Carlo" - U.O. Ematologia	Potenza
Italy	Ospedale delle Croci - Ematologia	Ravenna
Italy	Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia	Reggio Calabria
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	Istituto Oncologico del Mediterraneo SPA - Oncologico	Viagrande	Catania
Italy	ULSS 8 Berica - Ospedale S. Bortolo - Ematologia	Vicenza

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi - ETS	Roche Pharma AG

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	non-relapse mortality (NRM)	NRM is defined as death without recurrent or progressive disease after treatment.	At least 5 years
Primary	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
Primary	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