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Follicular LymphomaFIL_FOLL-BIONCT05816850

Multilayer Biological Characterization of Advanced Follicular Lymphoma: a Translational Study From FIL_FOLL12 Trial

An observational study of Follicular Lymphoma, run by Fondazione Italiana Linfomi - ETS at 26 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a Multicenter, Retrospective, Biological study ancillary to FOLL12 trial to evaluate the role of EZH2 aberrations in patient with FL treated with immunochemotherapy. Moreover, several novel biomarkers of FL will be investigated. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
EZH2 mutations/CNAs by droplet digital PCR (ddPCR) and EZH2-derived gene expression signature by RNA-Seq
How many people
654 participants
Where
26 sitesItaly
Study dates
19 Sep 2023to 1 Jun 2027
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: Patient affected by advanced Follicular Lymphoma treated with immunochemotherapy in the FIL_FOLL12 trial

Who may be able to join

  • Patient enrolled in the FIL_FOLL12 trial (documented by the signature of the study informed consent);
  • Availability of biological samples: bone marrow aspirate, peripheral blood and/or FFPE diagnostic sample (nodal or extranodal);

Who cannot join

  • None

Trial locations and contacts

26 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Uffici Studi FIL contact

+390131033153

startup@filinf.it

Uffici Studi FIL contact

+390599769913

gestionestudi@filinf.it

26 sites in 1 country

Italy26 sites, 26 recruiting
  • A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia

    Alessandria

    Manuela Zanni, MD, manuela.zanni@ospedale.al.it

    Manuela Zanni, MD

    Recruiting
  • Nuovo Ospedale degli Infermi, SSD Ematologia

    Biella

    Annarita Conconi, MD, annarita.conconi@aslbi.piemonte.it

    Annarita Conconi, MD

    Recruiting
  • ASST Spedali Civili di Brescia - Ematologia

    Brescia

    Antonella Anastasia, MD, antonella.anastasia@gmail.com

    Antonella Anastasia, MD

    Recruiting
  • Azienda Ospedaliera Universitaria Policlinico - S. Marco, UOC di Ematologia

    Catania

    Annalisa Chiarenza, MD, annalisa.chiarenza@gmail.com

    Annalisa Chiarenza, MD

    Recruiting
  • A.O. S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo

    Cuneo

    Claudia Castellino, MD, castellino.c@ospedale.cuneo.it

    Claudia Castellino, MD

    Not yet recruiting
  • Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

    Florence

    Benedetta Puccini, MD, puccinib@aou-careggi.toscana.it

    Benedetta Puccini, MD

    Not yet recruiting
  • Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia, Ematologia e terapie cellulari

    Genova

    Chiara Ghiggi, MD, chiara.ghiggi@hsanmartino.it

    Chiara Ghiggi, MD

    Recruiting
  • IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST S.R.L., Ematologia

    Meldola

    Gerardo Musuraca, MD, gerardo.musuraca@irst.emr.it

    Gerardo Musuraca, MD

    Recruiting
  • ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia

    Milan

    Vittorio Ruggero Zilioli, MD, vittorioruggero.zilioli@ospedaleniguarda.it

    Vittorio Ruggero Zilioli, MD

    Recruiting
  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Ematologia

    Milan

    Paolo Corradini, MD, paolo.corradini@unimi.it

    Paolo Corradini, MD

    Recruiting
  • Azienda Ospedaliero-Universitaria Policlinico di Modena, U.O. Oncologia

    Modena

    Alessia Bari, MD, alessia.bari@unimore.it

    Alessia Bari, MD

    Recruiting
  • Fondazione IRCCS San Gerardo dei Tintori - Ematologia

    Monza

    Silvia Bolis, MD, silviaanna.bolis@irccs-sangerardo.it

    Silvia Bolis, MD

    Recruiting
  • AOU Maggiore della Carità di Novara, SCDU Ematologia

    Novara

    Riccardo Moia, MD, riccardo.moia@uniupo.it

    Riccardo Moia, MD

    Recruiting
  • Presidio ospedaliero "A. Tortora", U.O. Onco-ematologia

    Pagani

    Catello Califano, MD, c.califano@aslsalerno.it

    Catello Califano, MD

    Recruiting
  • A.O. Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia

    Palermo

    Caterina Patti, MD, k.patti@villasofia.it

    Caterina Patti, MD

    Recruiting
  • IRCCS Policlinico S. Matteo di Pavia, Divisione di Ematologia

    Pavia

    Luca Arcaini, MD, luca.arcaini@unipv.it

    Luca Arcaini, MD

    Not yet recruiting
  • Ospedale Guglielmo da Saliceto, U.O. Ematologia

    Piacenza

    Annalisa Arcari, MD, a.arcari@ausl.pc.it

    Annalisa Arcari, MD

    Recruiting
  • Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia

    Reggio Calabria

    Caterina Stelitano, MD, caterinastelitano27@gmail.com

    Caterina Stelitano, MD

    Not yet recruiting
  • Ospedale degli Infermi di Rimini, U.O. di Ematologia

    Rimini

    Melania Celli, MD, melania.celli@auslromagna.it

    Melania Celli, MD

    Not yet recruiting
  • Policlinico Umberto I - Università "La Sapienza", Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione

    Roma

    Ilaria Del Giudice, MD, ilaria.delgiudice@uniroma1.it

    Ilaria Del Giudice, MD

    Recruiting
  • Istituto Clinico Humanitas, U.O. Ematologia

    Rozzano

    Francesca Ricci, MD, francesca.ricci@humanitas.it

    Francesca Ricci, MD

    Recruiting
  • A.O.U. Città della Salute e della Scienza di Torino, Ematologia Universitaria

    Torino

    Simone Ferrero, MD, simone.ferrero@unito.it

    Simone Ferrero, MD

    Recruiting
  • A.O.U. Città della Salute e della Scienza di Torino, S.C. Ematologia

    Torino

    Carola Boccomini, MD, cboccomini@cittadellasalute.to.it

    Carola Boccomini, MD

    Recruiting
  • A.O. C. Panico, U.O.C Ematologia e Trapianto

    Tricase

    Vincenzo Pavone, MD, salentoematologia@piafondazionepanico.it

    Vincenzo Pavone, MD

    Not yet recruiting
  • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), SOC Clinica Ematologica

    Udine

    Jacopo Olivieri, MD, jacopo.olivieri@asufc.sanita.fvg.it

    Jacopo Olivieri, MD

    Recruiting
  • Ospedale di Circolo - U.O.C Ematologia

    Varese

    Michele Merli, MD, michele.merli@asst-settelaghi.it

    Michele Merli, MD

    Not yet recruiting

Other trials in Italy

About this study

This is a Multicenter, Retrospective, Biological study ancillary to FOLL12 trial to evaluate the role of EZH2 aberrations in patient with FL treated with immunochemotherapy. Moreover, several novel biomarkers of FL will be investigated.

Read the detailed description

Current standard first-line treatment for advanced follicular lymphoma (FL) is still represented by chemoimmunotherapy combinations, with CHOP/CVP or bendamustine (B) as the main regimens with no standard criteria to prefer one over another.

EZH2 mutations have been associated with longer progression-free survival (PFS) in patients treated with CHOP/CVP regimens, but not with Bendamustine (independently from the type of anti-CD20 therapy received).

The FIL_FOLL12 trial (NCT02063685), a large phase III trial (with a pre-planned biological material sampling) enrolling 807 advanced FL patients treated with front-line R-CHOP or bendamustine-rituximab (BR), appears an ideal platform to validate the predictive value of EZH2 and its applicability to the clinical practice.

The aim of this study is to provide to clinicians a useful and practical biomarker to guide the choice of the most effective chemotherapy backbone (in addition to anti-CD20 immunotherapy) for first line treatment of patients with advanced FL (e.g. R-CHOP for EZH2 aberrated vs BR for EZH2 wild type patients).

Moreover, to implement an Italian network of laboratories able to provide these translational outputs within a rapid turnaround time.

Finally, taking advantage of the already collected BM and PB samples, several novel biomarkers of FL heterogeneity will be investigated, in particular: EZH2 protein expression in tumor samples, alternative molecular markers for minimal residual disease (MRD), clonal hematopoiesis of indeterminate potential (CHIP), pharmacogenomics and constitutional genomics as well as microbiome profiles.

Being tested
EZH2 mutations/CNAs by droplet digital PCR (ddPCR), EZH2-derived gene expression signature by RNA-Seq
Keywords
Lymphoma, Follicular, Immunochemotherapy, FL, Aberration, Mutation, EZH2, CHOP, Bendamustine, Biological, Rituximab, Biomarker
Medical subject headings
Lymphoma, Follicular, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EZH2 mutations/CNAs by droplet digital PCR (ddPCR)Diagnostic test

    Test of EZH2 mutations/CNAs by droplet digital PCR (ddPCR) in peripheral blood and in unsorted bone marrow aspirate samples at enrolment

  • EZH2-derived gene expression signature by RNA-SeqDiagnostic test

    Test of EZH2-derived gene expression signature by RNA-Seq in a subset of diagnostic FFPE samples

Study groups in NCT05816850
Study groupRoleWhat they receive
Patients enrolledPatient affected by advanced Follicular Lymphoma treated with immunochemotherapy in the FIL_FOLL12 trial
Receives: Diagnostic Test: EZH2 mutations/CNAs by droplet digital PCR (ddPCR); Diagnostic Test: EZH2-derived gene expression signature by RNA-Seq

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Time between the treatment start and the first documentation of recurrence, progression or death from any cause

    Measured: From treatment start up to 43 months

Secondary outcomes (2)
  1. Response rate

    Response rate (complete metabolic response/minimal residual disease (MRD) negativity) at the end of induction.

    Measured: From treatment start to 7 months (R-Bendamustine) or from treatment start to 5,6 months (R-CHOP)

  2. Concordance between EZH2 gene mutations/gains and EZH2-related gene expression signature

    Concordance between EZH2 gene mutations/gains and EZH2-related gene expression signature

    Measured: Before treatment start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start19 Sep 2023
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

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
Retrospective
Enrolment
654 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05816850
Sponsor's protocol ID
FIL_FOLL-BIO
Acronym
FIL_FOLL-BIO
Status last verified
Sep 2025
First submitted
4 Apr 2023
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Follicular Lymphoma, run by Fondazione Italiana Linfomi - ETS at 26 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 2 inclusion and 1 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 26 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?

Progression free survival (time frame: From treatment start up to 43 months). 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.

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