A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice
- Conditions
- Non-Hodgkin Lymphoma, B-cell
- Interventions
- Drug: "novel" MAB (alone or in combination)
- Registration Number
- NCT06008691
- Lead Sponsor
- Fondazione Italiana Linfomi - ETS
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- 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.
-
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA and AIFA). "novel" MAB (alone or in combination) 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.
- Primary Outcome Measures
Name Time Method 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.
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 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.
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.
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.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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (58)
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
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 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
ULSS 8 Berica - Ospedale S. Bortolo - Ematologia
🇮🇹Vicenza, Italy