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

Sponsor

Fondazione Italiana Linfomi - ETS (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06008691

Collaborator

Roche Pharma AG (Industry)

1,500

Enrollment

Locations

180

Anticipated Duration (Months)

25.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin Lymphoma, B-cell	Drug: "novel" MAB (alone or in combination)

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2038

Anticipated Study Completion Date :

Oct 1, 2038

Arms and Interventions

Arm	Intervention/Treatment
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.	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

Arm

Intervention/Treatment

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.

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

Outcome Measures

Primary Outcome Measures

Overall response rate (ORR) [At least 5 years]
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).
Complete Response rate (CRR) [At least 5 years]
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.
Progression free survival (PFS) [At least 5 years]
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.
Overall survival (OS) [At least 5 years]
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.
Event free survival (EFS) [At least 5 years]
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.
Time-to-next treatment (TTNT) [At least 5 years]
TTNT represents the interval from commencement of one treatment to initiation of the next line of therapy.
non-relapse mortality (NRM) [At least 5 years]
NRM is defined as death without recurrent or progressive disease after treatment.
Duration of response (DOR) [At least 5 years]
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.
Incidence of Early/Late Adverse Events [At least 5 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Istituto Oncologico del Mediterraneo SPA - Oncologico	Viagrande	Catania	Italy
2	Ospedale SS. Cosma e Damiano - Ospedale San Jacopo - SOS Oncoematologia ed ematologia clinica	Pescia	Pistoia	Italy
3	A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia	Alessandria		Italy
4	AOU Ospedali Riuniti - Clinica di Ematologia	Ancona		Italy
5	Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico	Avellino		Italy
6	IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati	Aviano		Italy
7	IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia	Bari		Italy
8	Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia	Barletta		Italy
9	Azienda Ospedaliera Papa Giovanni XXIII - Ematologia	Bergamo		Italy
10	Nuovo Ospedale degli Infermi - SSD Ematologia	Biella		Italy
11	Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Seragnoli"	Bologna		Italy
12	ASST Spedali Civili di Brescia - Ematologia	Brescia		Italy
13	Ospedale Businco - SC Ematologia e CTMO	Cagliari		Italy
14	Fondazione del Piemonte per l'Oncologia - IRCCS - Ematologia	Candiolo		Italy
15	Osp. civile di Carrara - Oncologia Medica	Carrara		Italy
16	Ospedale di Castelfranco Veneto - Ematologia	Castelfranco Veneto		Italy
17	Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia	Catania		Italy
18	Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia	Catania		Italy
19	Ospedale di Civitanova Marche - UOSD EMATOLOGIA AREA VASTA 3 MACERATA	Civitanova Marche		Italy
20	A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo	Cuneo		Italy
21	Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia	Firenze		Italy
22	Ospedale Versilia USL NORDOVEST Toscana - UOS Ematologia	Lido Di Camaiore		Italy
23	Ospedale di Livorno - Ematologia	Livorno		Italy
24	AOU G. Martino - U.O.C. Ematologia	Messina		Italy
25	ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia	Milano		Italy
26	Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia	Milano		Italy
27	Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia	Milano		Italy
28	Fondazione IRCCS San Gerardo dei Tintori - Ematologia	Monza		Italy
29	AOU Federico II - Ematologia	Napoli		Italy
30	AOU Maggiore della Carità di Novara - SCDU Ematologia	Novara		Italy
31	I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1	Padova		Italy
32	Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia	Pagani		Italy
33	A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia	Palermo		Italy
34	IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia	Pavia		Italy
35	P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi	Pescara		Italy
36	Ospedale Guglielmo da Saliceto - U.O. Ematologia	Piacenza		Italy
37	A.O.R. "San Carlo" - U.O. Ematologia	Potenza		Italy
38	Ospedale delle Croci - Ematologia	Ravenna		Italy
39	Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia	Reggio Calabria		Italy
40	Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia	Reggio Emilia		Italy
41	IRCCS-Centro di Riferimento Oncologico - UO di ematologia e Trapianto Cellule Staminali	Rionero In Vulture		Italy
42	AO Sant' Andrea - Ematologia	Roma		Italy
43	Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione	Roma		Italy
44	Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare	Roma		Italy
45	Istituto Clinico Humanitas - U.O. Ematologia	Rozzano		Italy
46	AOU di Sassari - Ematologia	Sassari		Italy
47	Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico	Sassuolo		Italy
48	AOU Senese - U.O.C. Ematologia	Siena		Italy
49	Ospedale "G. Mazzini" - UOS Ematologia	Teramo		Italy
50	A.O. S. Maria di Terni - S.C. Oncoematologia	Terni		Italy
51	A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria	Torino		Italy
52	A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia	Torino		Italy
53	Ospedale Ca' Foncello - S.C di Ematologia	Treviso		Italy
54	A.O. C. Panico - U.O.C Ematologia e Trapianto	Tricase		Italy
55	Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia	Trieste		Italy
56	Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica	Udine		Italy
57	AOU Integrata di Verona - U.O. Ematologia	Verona		Italy
58	ULSS 8 Berica - Ospedale S. Bortolo - Ematologia	Vicenza		Italy