Non-Hodgkin Lymphoma, B-cellFIL_MABNCT06008691
A Prospective, Observational Cohort Study on the Clinical Impact of Novel Monoclonal Antibodies in B-cell Non-Hodgkin Lymphoma in Italian Clinical Practice
An observational study of Non-Hodgkin Lymphoma, B-cell, run by Fondazione Italiana Linfomi - ETS at 61 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin Lymphoma, B-cell
- What is being tested?
- "novel" MAB (alone or in combination)
- How many people
- 1,500 participants
- Where
- 61 sitesItaly
- Study dates
- 27 Dec 2023to Oct 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
61 sites in 1 country. Contact the study team or a site near you to ask about taking part.
61 sites in 1 country
Italy61 sites, 61 recruiting
- Recruiting
A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia
Alessandria
Marco Ladetto, Prof., marco.ladetto@ospedale.al.it
- Recruiting
AOU Ospedali Riuniti - Clinica di Ematologia
Ancona
Guido Gini, MD, guido.gini@ospedaliriuniti.marche.it
- Recruiting
Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Avellino
Sonya De Lorenzo, MD, sonya.delorenzo@tin.it
- Recruiting
IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
Aviano
Michele Spina, MD, mspina@cro.it
- Recruiting
IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia
Bari
Giacomo Loseto, MD, loseto.giacomo@gmail.com
- Not yet recruiting
Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
Barletta
Giuseppe Tarantini, MD, giuseppetarantini0@gmail.com
- Recruiting
Azienda Ospedaliera Papa Giovanni XXIII - Ematologia
Bergamo
Alessandro Rambaldi, MD, arambaldi@asst-pg23.it
- Recruiting
Nuovo Ospedale degli Infermi - SSD Ematologia
Biella
Annarita Conconi, MD, annarita.conconi@aslbi.piemonte.it
- Recruiting
Policlinico S. Orsola-Malpighi - Istituto di Ematologia "Seragnoli"
Bologna
Beatrice Casadei, MD, beatrice.casadei10@unibo.it
- Recruiting
ASST Spedali Civili di Brescia - Ematologia
Brescia
Alessandro Re, MD, alessandro.re@asst-spedalicivili.it
- Not yet recruiting
Ospedale Businco - SC Ematologia e CTMO
Cagliari
Maria Pina Simula, MD, mariap.simula@aob.it
- Recruiting
Fondazione del Piemonte per l'Oncologia - IRCCS - Ematologia
Candiolo
Pio Manlio Mirko Frascione, MD, piomanliomirko.frascione@ircc.it
- Recruiting
Osp. civile di Carrara - Oncologia Medica
Carrara
Roberta Della Seta, MD, rdellaseta@alice.it
- Recruiting
Ospedale di Castelfranco Veneto - Ematologia
Castelfranco Veneto
Mariella Lo Schirico, MD, mariella.loschirico@iov.veneto.it
- Recruiting
Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
Catania
Ugo Consoli, MD, ugo.consoli144@gmail.com
- Recruiting
Azienda Ospedaliera Universitaria Policlinico - S. Marco - UOC di Emtologia
Catania
Annalisa Chiarenza, MD, annalisa.chiarenza@gmail.com
- Recruiting
Ospedale di Civitanova Marche - UOSD EMATOLOGIA AREA VASTA 3 MACERATA
Civitanova Marche
Caterina Bocci, MD, cate.bocci@gmail.com
- Recruiting
ASST Cremona - Ematologia e CRTO
Cremona
Alfredo Molteni, MD, alfredo.molteni@asst-cremona.it
- Recruiting
A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo
Cuneo
Alessia Castellino, MD, castellino.ale@ospedale.cuneo.it
- Recruiting
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
Florence
Luca Nassi, MD, nassil@aou-careggi.toscana.it
- Recruiting
Presidio Ospedaliero F. Spaziani - UOC Ematologia
Frosinone
Antonella Ferrari, MD, antonella.ferrari@aslfrosinone.it
- Recruiting
Ospedale Versilia USL NORDOVEST Toscana - UOS Ematologia
Lido di Camaiore
Federico Simonetti, MD, federico.simonetti@uslnordovest.toscana.it
- Recruiting
Ospedale di Livorno - Ematologia
Livorno
Sofya Kovalchuk, MD, sofya.kova82@gmail.com
- Recruiting
Ospedale Apuane - Oncoematologia
Massa
Roberta Della Seta, MD, rdellaseta@alice.it
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan
Vittorio Ruggero Zilioli, MD, vittorioruggero.zilioli@ospedaleniguarda.it
- Recruiting
ASST Santi Paolo e Carlo - Onco - Ematologia
Milan
Vittorio Montefusco, MD, vittorio.montefusco@asst-santipaolocarlo.it
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano - Ematologia
Milan
Paolo Corradini, Prof., paolo.corradini@unimi.it
- Recruiting
Istituto Scientifico San Raffaele - Unità Linfomi - Dipartimento Oncoematologia
Milan
Andrès Ferreri, MD, andres.ferreri@hsr.it
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori - Ematologia
Monza
Federica Cocito, MD, cocitofederica@gmail.com
- Not yet recruiting
AOU Federico II - Ematologia
Naples
Fabrizio Pane, Prof., fabrizio.pane@unina.it
- Recruiting
AOU Maggiore della Carità di Novara - SCDU Ematologia
Novara
Riccardo Bruna, MD, riccardo.bruna@med.uniupo.it
- Recruiting
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1
Padova
Dario Marino, MD, dario.marino@iov.veneto.it
- Not yet recruiting
Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia
Pagani
Catello Califano, MD, c.califano@aslsalerno.it
- Not yet recruiting
A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
Palermo
Caterina Patti, MD, k.patti@villasofia.it
- Not yet recruiting
IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia
Pavia
Luca Arcaini, Prof., luca.arcaini@unipv.it
- Recruiting
P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
Pescara
Elsa Pennese, MD, elsa.pennese@asl.pe.it
- Recruiting
Ospedale SS. Cosma e Damiano - Ospedale San Jacopo - SOS Oncoematologia ed ematologia clinica
Pescia, Pistoia
Roberta Giachetti, MD, roberta.giachetti@uslcentro.toscana.it
- Recruiting
Ospedale Guglielmo da Saliceto - U.O. Ematologia
Piacenza
Annalisa Arcari, MD, a.arcari@ausl.pc.it
- Not yet recruiting
A.O.R. "San Carlo" - U.O. Ematologia
Potenza
Michele Cimminiello, MD, miki-doc@virgilio.it
- Recruiting
Ospedale S.Stefano SOS Oncoematologia
Prato
Lara Mannelli, MD, lara.mannelli@uslcentro.toscana.it
- Recruiting
Ospedale delle Croci - Ematologia
Ravenna
Monica Tani, MD, monica.tani@auslromagna.it
- Recruiting
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia
Reggio Emilia
Stefano Luminari, Prof., stefano.luminari@ausl.re.it
- Recruiting
IRCCS-Centro di Riferimento Oncologico - UO di ematologia e Trapianto Cellule Staminali
Rionero in Vulture
Giuseppe Pietrantuono, MD, ematologia45@alice.it
- Recruiting
AO Sant' Andrea - Ematologia
Roma
Agostino Tafuri, Prof., agostino.tafuri@ospedalesantandrea.it
- Recruiting
Policlinico Umberto I - Università "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
Roma
Alice Di Rocco, MD, dirocco@bce.uniroma1.it
- Recruiting
Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
Roma
Luigi Rigacci, MD, l.rigacci@policlinicocampus.it
- Recruiting
Istituto Clinico Humanitas - U.O. Ematologia
Rozzano
Monica Balzarotti, MD, monica.balzarotti@humanitas.it
- Not yet recruiting
AOU di Sassari - Ematologia
Sassari
Claudio Fozza, Prof., cfozza@uniss.it
- Recruiting
Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico
Sassuolo
Sara Bigliardi, MD, s.bigliardi@ausl.mo.it
- Recruiting
AOU Senese - U.O.C. Ematologia
Siena
Alberto Fabbri, MD, fabbri7@unisi.it
- Not yet recruiting
Ospedale "G. Mazzini" - UOS Ematologia
Teramo
Angelo Fama, MD, angelo.fama@aslteramo.it
- Not yet recruiting
A.O. S. Maria di Terni - S.C. Oncoematologia
Terni
Anna Marina Liberati, Prof., marina.liberati@unipg.it
- Recruiting
A.O.U. Città della Salute e della Scienza di Torino - Ematologia Universitaria
Torino
Federica Cavallo, MD, f.cavallo@unito.it
- Recruiting
A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia
Torino
Maura Nicolosi, MD, manicolosi@cittadellasalute.to.it
- Recruiting
Ospedale Ca' Foncello - S.C di Ematologia
Treviso
Elisabetta Scarpa, MD, elisabetta.scarpa@aulss2.veneto.it
- Recruiting
A.O. C. Panico - U.O.C Ematologia e Trapianto
Tricase
Vincenzo Pavone, MD, salentoematologia@piafondazionepanico.it
- Recruiting
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia
Trieste
Francesco Zaja, Prof., francesco.zaja@asugi.sanita.fvg.it
- Recruiting
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica
Udine
Jacopo Olivieri, MD, jacopo.olivieri@asufc.sanita.fvg.it
- Recruiting
AOU Integrata di Verona - U.O. Ematologia
Verona
Carlo Visco, Prof., carlo.visco@univr.it
- Not yet recruiting
Istituto Oncologico del Mediterraneo SPA - Oncologico
Viagrande, Catania
Giulio Antonio Milone, MD, giulio.milone89@gmail.com
- Recruiting
ULSS 8 Berica - Ospedale S. Bortolo - Ematologia
Vicenza
Maria Chiara Tisi, MD, mariachiara.tisi@aulss8.veneto.it
About this study
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
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.
Read the 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.
- Conditions
- Non-Hodgkin Lymphoma, B-cell
- Being tested
- "novel" MAB (alone or in combination)
- Keywords
- Non-Hodgkin Lymphoma, B-cell, monoclonal antibodies, novel antibodies
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"novel" MAB (alone or in combination)Drug
"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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: "novel" MAB (alone or in combination) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At least 5 years
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.
Measured: At least 5 years
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.
Measured: At least 5 years
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.
Measured: At least 5 years
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.
Measured: At least 5 years
Time-to-next treatment (TTNT)
TTNT represents the interval from commencement of one treatment to initiation of the next line of therapy.
Measured: At least 5 years
non-relapse mortality (NRM)
NRM is defined as death without recurrent or progressive disease after treatment.
Measured: At least 5 years
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.
Measured: At least 5 years
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.
Measured: At least 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start27 Dec 2023
- Primary completionOct 2038 (estimated)
- Study completionOct 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin Lymphoma, B-cellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Marco Ladetto, Prof., Principal investigator, AO SS Antonio e Biagio e Cesare Arrigo, Alessandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008691
- Sponsor's protocol ID
- FIL_MAB
- Acronym
- FIL_MAB
- Status last verified
- Dec 2025
- First submitted
- 11 Aug 2023
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06008691
- Acronym / sponsor ID
- FIL_MAB / FIL_MAB
- Conditions
- Non-Hodgkin Lymphoma, B-cell
- Keywords
- Non-Hodgkin Lymphoma, B-cell, monoclonal antibodies, novel antibodies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- Oct 2038 (estimated)
- Study completion
- Oct 2038 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA and AIFA). | – | Drug: "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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Being involved in a prospective interventional trial outside indication.
- Patients treated outside approved indications:
- Age less than 18 years.
- Inability to provide an informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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 | Drug | B-cell NHL patients treated with novel MAB in Italian real life (approved by EMA and AIFA). |
Primary outcome
Overall response rate (ORR)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: At least 5 years
NRM is defined as death without recurrent or progressive disease after treatment.
Duration of response (DOR)
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
Related trials for Non-Hodgkin Lymphoma, B-cell
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Not yet recruitingPhase 2
QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
Plasmablastic Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marco Ladetto, Prof. principal investigator
AO SS Antonio e Biagio e Cesare Arrigo, Alessandria
61 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hodgkin Lymphoma, B-cell, run by Fondazione Italiana Linfomi - ETS at 61 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uffici Studi FIL (+390131033153, startup@filinf.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: At least 5 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.