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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

654 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-19

Study Completion Date

2027-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Follicular Lymphoma

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Lymphoma Follicular Immunochemotherapy FL Aberration Mutation EZH2 CHOP Bendamustine Biological Rituximab Biomarker

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients enrolled

Patient affected by advanced Follicular Lymphoma treated with immunochemotherapy in the FIL\_FOLL12 trial

EZH2 mutations/CNAs by droplet digital PCR (ddPCR)

Intervention Type 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-Seq

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EZH2 mutations/CNAs by droplet digital PCR (ddPCR)

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

Intervention Type DIAGNOSTIC_TEST

EZH2-derived gene expression signature by RNA-Seq

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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);

Exclusion Criteria

* None

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Simone Ferrero, MD

Role: PRINCIPAL_INVESTIGATOR

SC Ematologia U - AOU Città della Salute e della Scienza di Torino

Reach out to these primary contacts for questions about participation or study logistics.

Uffici Studi FIL

Role: CONTACT

Phone: +390131033153

Email: [email protected]

Uffici Studi FIL

Role: CONTACT

Phone: +390599769913

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Patients enrolled

EZH2 mutations/CNAs by droplet digital PCR (ddPCR)

EZH2-derived gene expression signature by RNA-Seq

Interventions

EZH2 mutations/CNAs by droplet digital PCR (ddPCR)

EZH2-derived gene expression signature by RNA-Seq

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Fondazione Italiana Linfomi - ETS

Responsible Party

Principal Investigators

Simone Ferrero, MD

Locations

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

Nuovo Ospedale degli Infermi, SSD Ematologia

ASST Spedali Civili di Brescia - Ematologia

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

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

Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

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

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

ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Ematologia

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

Fondazione IRCCS San Gerardo dei Tintori - Ematologia

AOU Maggiore della Carità di Novara, SCDU Ematologia

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

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

IRCCS Policlinico S. Matteo di Pavia, Divisione di Ematologia

Ospedale Guglielmo da Saliceto, U.O. Ematologia

Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia

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

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

Istituto Clinico Humanitas, U.O. Ematologia

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

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

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

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

Ospedale di Circolo - U.O.C Ematologia

Countries

Central Contacts

Uffici Studi FIL

Uffici Studi FIL

Facility Contacts

Manuela Zanni, MD

Annarita Conconi, MD

Antonella Anastasia, MD

Annalisa Chiarenza, MD

Claudia Castellino, MD

Benedetta Puccini, MD

Chiara Ghiggi, MD

Gerardo Musuraca, MD

Vittorio Ruggero Zilioli, MD

Paolo Corradini, MD

Alessia Bari, MD

Silvia Bolis, MD

Riccardo Moia, MD

Catello Califano, MD

Caterina Patti, MD

Luca Arcaini, MD

Annalisa Arcari, MD

Caterina Stelitano, MD

Melania Celli, MD

Ilaria Del Giudice, MD

Francesca Ricci, MD

Simone Ferrero, MD

Carola Boccomini, MD

Vincenzo Pavone, MD

Jacopo Olivieri, MD