Trial Title:
Multilayer Biological Characterization of Advanced Follicular Lymphoma: a Translational Study From FIL_FOLL12 Trial
NCT ID:
NCT05816850
Condition:
Follicular Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Conditions: Keywords:
Lymphoma
Follicular
Immunochemotherapy
FL
Aberration
Mutation
EZH2
CHOP
Bendamustine
Biological
Rituximab
Biomarker
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
EZH2 mutations/CNAs by droplet digital PCR (ddPCR)
Description:
Test of EZH2 mutations/CNAs by droplet digital PCR (ddPCR) in peripheral blood and in
unsorted bone marrow aspirate samples at enrolment
Arm group label:
Patients enrolled
Intervention type:
Diagnostic Test
Intervention name:
EZH2-derived gene expression signature by RNA-Seq
Description:
Test of EZH2-derived gene expression signature by RNA-Seq in a subset of diagnostic FFPE
samples
Arm group label:
Patients enrolled
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.
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.
Criteria for eligibility:
Study pop:
Patient affected by advanced Follicular Lymphoma treated with immunochemotherapy in the
FIL_FOLL12 trial
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia
Address:
City:
Alessandria
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Manuela Zanni, MD
Email:
manuela.zanni@ospedale.al.it
Investigator:
Last name:
Manuela Zanni, MD
Email:
Principal Investigator
Facility:
Name:
Nuovo Ospedale degli Infermi, SSD Ematologia
Address:
City:
Biella
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Annarita Conconi, MD
Email:
annarita.conconi@aslbi.piemonte.it
Investigator:
Last name:
Annarita Conconi, MD
Email:
Principal Investigator
Facility:
Name:
ASST Spedali Civili di Brescia - Ematologia
Address:
City:
Brescia
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Antonella Anastasia, MD
Email:
antonella.anastasia@gmail.com
Investigator:
Last name:
Antonella Anastasia, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Universitaria Policlinico - S. Marco, UOC di Ematologia
Address:
City:
Catania
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Annalisa Chiarenza, MD
Email:
annalisa.chiarenza@gmail.com
Investigator:
Last name:
Annalisa Chiarenza, MD
Email:
Principal Investigator
Facility:
Name:
A.O. S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo
Address:
City:
Cuneo
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Claudia Castellino, MD
Email:
castellino.c@ospedale.cuneo.it
Investigator:
Last name:
Claudia Castellino, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
Address:
City:
Firenze
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Benedetta Puccini, MD
Email:
puccinib@aou-careggi.toscana.it
Investigator:
Last name:
Benedetta Puccini, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia, Ematologia e terapie cellulari
Address:
City:
Genova
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Chiara Ghiggi, MD
Email:
chiara.ghiggi@hsanmartino.it
Investigator:
Last name:
Chiara Ghiggi, MD
Email:
Principal Investigator
Facility:
Name:
IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST S.R.L., Ematologia
Address:
City:
Meldola
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Gerardo Musuraca, MD
Email:
gerardo.musuraca@irst.emr.it
Investigator:
Last name:
Gerardo Musuraca, MD
Email:
Principal Investigator
Facility:
Name:
ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia
Address:
City:
Milano
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Vittorio Ruggero Zilioli, MD
Email:
vittorioruggero.zilioli@ospedaleniguarda.it
Investigator:
Last name:
Vittorio Ruggero Zilioli, MD
Email:
Principal Investigator
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Ematologia
Address:
City:
Milano
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Paolo Corradini, MD
Email:
paolo.corradini@unimi.it
Investigator:
Last name:
Paolo Corradini, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliero-Universitaria Policlinico di Modena, U.O. Oncologia
Address:
City:
Modena
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Alessia Bari, MD
Email:
alessia.bari@unimore.it
Investigator:
Last name:
Alessia Bari, MD
Email:
Principal Investigator
Facility:
Name:
Fondazione IRCCS San Gerardo dei Tintori - Ematologia
Address:
City:
Monza
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Silvia Bolis, MD
Email:
silviaanna.bolis@irccs-sangerardo.it
Investigator:
Last name:
Silvia Bolis, MD
Email:
Principal Investigator
Facility:
Name:
AOU Maggiore della Carità di Novara, SCDU Ematologia
Address:
City:
Novara
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Riccardo Moia, MD
Email:
riccardo.moia@uniupo.it
Investigator:
Last name:
Riccardo Moia, MD
Email:
Principal Investigator
Facility:
Name:
Presidio ospedaliero "A. Tortora", U.O. Onco-ematologia
Address:
City:
Pagani
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Catello Califano, MD
Email:
c.califano@aslsalerno.it
Investigator:
Last name:
Catello Califano, MD
Email:
Principal Investigator
Facility:
Name:
A.O. Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia
Address:
City:
Palermo
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Caterina Patti, MD
Email:
k.patti@villasofia.it
Investigator:
Last name:
Caterina Patti, MD
Email:
Principal Investigator
Facility:
Name:
IRCCS Policlinico S. Matteo di Pavia, Divisione di Ematologia
Address:
City:
Pavia
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Luca Arcaini, MD
Email:
luca.arcaini@unipv.it
Investigator:
Last name:
Luca Arcaini, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale Guglielmo da Saliceto, U.O. Ematologia
Address:
City:
Piacenza
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Annalisa Arcari, MD
Email:
a.arcari@ausl.pc.it
Investigator:
Last name:
Annalisa Arcari, MD
Email:
Principal Investigator
Facility:
Name:
Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia
Address:
City:
Reggio Calabria
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Caterina Stelitano, MD
Email:
caterinastelitano27@gmail.com
Investigator:
Last name:
Caterina Stelitano, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale degli Infermi di Rimini, U.O. di Ematologia
Address:
City:
Rimini
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Melania Celli, MD
Email:
melania.celli@auslromagna.it
Investigator:
Last name:
Melania Celli, MD
Email:
Principal Investigator
Facility:
Name:
Policlinico Umberto I - Università "La Sapienza", Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
Address:
City:
Roma
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Ilaria Del Giudice, MD
Email:
ilaria.delgiudice@uniroma1.it
Investigator:
Last name:
Ilaria Del Giudice, MD
Email:
Principal Investigator
Facility:
Name:
Istituto Clinico Humanitas, U.O. Ematologia
Address:
City:
Rozzano
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Francesca Ricci, MD
Email:
francesca.ricci@humanitas.it
Investigator:
Last name:
Francesca Ricci, MD
Email:
Principal Investigator
Facility:
Name:
A.O.U. Città della Salute e della Scienza di Torino, Ematologia Universitaria
Address:
City:
Torino
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Simone Ferrero, MD
Email:
simone.ferrero@unito.it
Investigator:
Last name:
Simone Ferrero, MD
Email:
Principal Investigator
Facility:
Name:
A.O.U. Città della Salute e della Scienza di Torino, S.C. Ematologia
Address:
City:
Torino
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Carola Boccomini, MD
Email:
cboccomini@cittadellasalute.to.it
Investigator:
Last name:
Carola Boccomini, MD
Email:
Principal Investigator
Facility:
Name:
A.O. C. Panico, U.O.C Ematologia e Trapianto
Address:
City:
Tricase
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Vincenzo Pavone, MD
Email:
salentoematologia@piafondazionepanico.it
Investigator:
Last name:
Vincenzo Pavone, MD
Email:
Principal Investigator
Facility:
Name:
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), SOC Clinica Ematologica
Address:
City:
Udine
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Jacopo Olivieri, MD
Email:
jacopo.olivieri@asufc.sanita.fvg.it
Investigator:
Last name:
Jacopo Olivieri, MD
Email:
Principal Investigator
Facility:
Name:
Ospedale di Circolo - U.O.C Ematologia
Address:
City:
Varese
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Michele Merli, MD
Email:
michele.merli@asst-settelaghi.it
Investigator:
Last name:
Michele Merli, MD
Email:
Principal Investigator
Start date:
September 19, 2023
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Fondazione Italiana Linfomi - ETS
Agency class:
Other
Source:
Fondazione Italiana Linfomi - ETS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05816850
