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

Last updated: September 4, 2025
Sponsor: Fondazione Italiana Linfomi - ETS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoma

Follicular Lymphoma

Lymphoproliferative Disorders

Treatment

EZH2-derived gene expression signature by RNA-Seq

EZH2 mutations/CNAs by droplet digital PCR (ddPCR)

Clinical Study ID

NCT05816850
FIL_FOLL-BIO
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient enrolled in the FIL_FOLL12 trial (documented by the signature of the studyinformed consent);

  • Availability of biological samples: bone marrow aspirate, peripheral blood and/orFFPE diagnostic sample (nodal or extranodal);

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 654
Treatment Group(s): 2
Primary Treatment: EZH2-derived gene expression signature by RNA-Seq
Phase:
Study Start date:
September 19, 2023
Estimated Completion Date:
June 01, 2026

Study 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.

Connect with a study center

  • A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia

    Alessandria,
    Italy

    Site Not Available

  • A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia

    Alessandria 3183299,
    Italy

    Active - Recruiting

  • Nuovo Ospedale degli Infermi, SSD Ematologia

    Biella,
    Italy

    Site Not Available

  • Nuovo Ospedale degli Infermi, SSD Ematologia

    Biella 3182043,
    Italy

    Active - Recruiting

  • ASST Spedali Civili di Brescia - Ematologia

    Brescia,
    Italy

    Site Not Available

  • ASST Spedali Civili di Brescia - Ematologia

    Brescia 3181554,
    Italy

    Active - Recruiting

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

    Catania,
    Italy

    Site Not Available

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

    Catania 2525068,
    Italy

    Active - Recruiting

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

    Cuneo,
    Italy

    Site Not Available

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

    Cuneo 3177700,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

    Firenze,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

    Florence 3176959,
    Italy

    Site Not Available

  • Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia, Ematologia e terapie cellulari

    Genova,
    Italy

    Site Not Available

  • Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia, Ematologia e terapie cellulari

    Genova 8969657,
    Italy

    Active - Recruiting

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

    Meldola,
    Italy

    Site Not Available

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

    Meldola 3173635,
    Italy

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia

    Milan 6951411,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Ematologia

    Milan 6951411,
    Italy

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia

    Milano,
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Ematologia

    Milano,
    Italy

    Active - Recruiting

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

    Modena,
    Italy

    Site Not Available

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

    Modena 3173331,
    Italy

    Active - Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori - Ematologia

    Monza,
    Italy

    Site Not Available

  • Fondazione IRCCS San Gerardo dei Tintori - Ematologia

    Monza 3172629,
    Italy

    Active - Recruiting

  • AOU Maggiore della Carità di Novara, SCDU Ematologia

    Novara,
    Italy

    Site Not Available

  • AOU Maggiore della Carità di Novara, SCDU Ematologia

    Novara 3172189,
    Italy

    Active - Recruiting

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

    Pagani,
    Italy

    Site Not Available

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

    Pagani 3171703,
    Italy

    Active - Recruiting

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

    Palermo,
    Italy

    Site Not Available

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

    Palermo 2523920,
    Italy

    Active - Recruiting

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

    Pavia,
    Italy

    Site Not Available

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

    Pavia 3171366,
    Italy

    Site Not Available

  • Ospedale Guglielmo da Saliceto, U.O. Ematologia

    Piacenza,
    Italy

    Site Not Available

  • Ospedale Guglielmo da Saliceto, U.O. Ematologia

    Piacenza 3171058,
    Italy

    Active - Recruiting

  • Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia

    Reggio Calabria,
    Italy

    Site Not Available

  • Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia

    Reggio Calabria 2523630,
    Italy

    Site Not Available

  • Ospedale degli Infermi di Rimini, U.O. di Ematologia

    Rimini,
    Italy

    Site Not Available

  • Ospedale degli Infermi di Rimini, U.O. di Ematologia

    Rimini 3169361,
    Italy

    Site Not Available

  • Policlinico Umberto I - Università "La Sapienza", Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione

    Roma,
    Italy

    Site Not Available

  • Policlinico Umberto I - Università "La Sapienza", Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione

    Roma 8957247,
    Italy

    Active - Recruiting

  • Istituto Clinico Humanitas, U.O. Ematologia

    Rozzano,
    Italy

    Site Not Available

  • Istituto Clinico Humanitas, U.O. Ematologia

    Rozzano 3168837,
    Italy

    Active - Recruiting

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

    Torino,
    Italy

    Site Not Available

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

    Torino,
    Italy

    Active - Recruiting

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

    Torino 8980539,
    Italy

    Active - Recruiting

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

    Torino 8980539,
    Italy

    Active - Recruiting

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

    Tricase,
    Italy

    Site Not Available

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

    Tricase 2522857,
    Italy

    Site Not Available

  • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), SOC Clinica Ematologica

    Udine,
    Italy

    Site Not Available

  • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), SOC Clinica Ematologica

    Udine 3165072,
    Italy

    Active - Recruiting

  • Ospedale di Circolo - U.O.C Ematologia

    Varese,
    Italy

    Site Not Available

  • Ospedale di Circolo - U.O.C Ematologia

    Varese 3164699,
    Italy

    Site Not Available

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