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

NCT05816850 · tracked via the Priya Life Science Italy tracker

Sponsor

Fondazione Italiana Linfomi - ETS

Phase

Observational

Started

2023-09-19

Last updated

2025-12-29

Condition(s) studied

Follicular Lymphoma

Investigational drug(s) / intervention(s)

EZH2 mutations/CNAs by droplet digital PCR (ddPCR)EZH2-derived gene expression signature by RNA-Seq

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

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

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Progression free survival — From treatment start up to 43 months
Time between the treatment start and the first documentation of recurrence, progression or death from any cause

Trial sites (26)

Facility	City	Region	Status
A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia	Alessandria	Italy	Recruiting
Nuovo Ospedale degli Infermi, SSD Ematologia	Biella	Italy	Recruiting
ASST Spedali Civili di Brescia - Ematologia	Brescia	Italy	Recruiting
Azienda Ospedaliera Universitaria Policlinico - S. Marco, UOC di Ematologia	Catania	Italy	Recruiting
A.O. S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo	Cuneo	Italy	Not Yet Recruiting
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia	Florence	Italy	Not Yet Recruiting
Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia, Ematologia e terapie cellulari	Genova	Italy	Recruiting
IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST S.R.L., Ematologia	Meldola	Italy	Recruiting
ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia	Milan	Italy	Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Ematologia	Milan	Italy	Recruiting
Azienda Ospedaliero-Universitaria Policlinico di Modena, U.O. Oncologia	Modena	Italy	Recruiting
Fondazione IRCCS San Gerardo dei Tintori - Ematologia	Monza	Italy	Recruiting
AOU Maggiore della Carità di Novara, SCDU Ematologia	Novara	Italy	Recruiting
Presidio ospedaliero "A. Tortora", U.O. Onco-ematologia	Pagani	Italy	Recruiting
A.O. Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia	Palermo	Italy	Recruiting
IRCCS Policlinico S. Matteo di Pavia, Divisione di Ematologia	Pavia	Italy	Not Yet Recruiting
Ospedale Guglielmo da Saliceto, U.O. Ematologia	Piacenza	Italy	Recruiting
Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia	Reggio Calabria	Italy	Not Yet Recruiting
Ospedale degli Infermi di Rimini, U.O. di Ematologia	Rimini	Italy	Not Yet Recruiting
Policlinico Umberto I - Università "La Sapienza", Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione	Roma	Italy	Recruiting
Istituto Clinico Humanitas, U.O. Ematologia	Rozzano	Italy	Recruiting
A.O.U. Città della Salute e della Scienza di Torino, Ematologia Universitaria	Torino	Italy	Recruiting
A.O.U. Città della Salute e della Scienza di Torino, S.C. Ematologia	Torino	Italy	Recruiting
A.O. C. Panico, U.O.C Ematologia e Trapianto	Tricase	Italy	Not Yet Recruiting
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), SOC Clinica Ematologica	Udine	Italy	Recruiting
Ospedale di Circolo - U.O.C Ematologia	Varese	Italy	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05816850 on ClinicalTrials.gov ↗ ← All trials in Italy