Multilayer Biological Characterization of Advanced Follicular Lymphoma: a Translational Study From FIL_FOLL12 Trial
FIL_FOLL-BIO
1 other identifier
observational
654
1 country
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2023
Typical duration for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2023
CompletedFirst Posted
Study publicly available on registry
April 18, 2023
CompletedStudy Start
First participant enrolled
September 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
December 29, 2025
September 1, 2025
3.2 years
April 4, 2023
December 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
Time between the treatment start and the first documentation of recurrence, progression or death from any cause
From treatment start up to 43 months
Secondary Outcomes (2)
Response rate
From treatment start to 7 months (R-Bendamustine) or from treatment start to 5,6 months (R-CHOP)
Concordance between EZH2 gene mutations/gains and EZH2-related gene expression signature
Before treatment start
Study Arms (1)
Patients enrolled
Patient affected by advanced Follicular Lymphoma treated with immunochemotherapy in the FIL\_FOLL12 trial
Interventions
Test of EZH2 mutations/CNAs by droplet digital PCR (ddPCR) in peripheral blood and in unsorted bone marrow aspirate samples at enrolment
Test of EZH2-derived gene expression signature by RNA-Seq in a subset of diagnostic FFPE samples
Eligibility Criteria
Patient affected by advanced Follicular Lymphoma treated with immunochemotherapy in the FIL\_FOLL12 trial
You may qualify if:
- 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);
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia
Alessandria, Italy
Nuovo Ospedale degli Infermi, SSD Ematologia
Biella, Italy
ASST Spedali Civili di Brescia - Ematologia
Brescia, Italy
Azienda Ospedaliera Universitaria Policlinico - S. Marco, UOC di Ematologia
Catania, Italy
A.O. S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo
Cuneo, Italy
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
Florence, Italy
Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia, Ematologia e terapie cellulari
Genova, Italy
IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST S.R.L., Ematologia
Meldola, Italy
ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Ematologia
Milan, Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena, U.O. Oncologia
Modena, Italy
Fondazione IRCCS San Gerardo dei Tintori - Ematologia
Monza, Italy
AOU Maggiore della Carità di Novara, SCDU Ematologia
Novara, Italy
Presidio ospedaliero "A. Tortora", U.O. Onco-ematologia
Pagani, Italy
A.O. Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia
Palermo, Italy
IRCCS Policlinico S. Matteo di Pavia, Divisione di Ematologia
Pavia, Italy
Ospedale Guglielmo da Saliceto, U.O. Ematologia
Piacenza, Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia
Reggio Calabria, Italy
Ospedale degli Infermi di Rimini, U.O. di Ematologia
Rimini, Italy
Policlinico Umberto I - Università "La Sapienza", Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
Roma, Italy
Istituto Clinico Humanitas, U.O. Ematologia
Rozzano, Italy
A.O.U. Città della Salute e della Scienza di Torino, Ematologia Universitaria
Torino, Italy
A.O.U. Città della Salute e della Scienza di Torino, S.C. Ematologia
Torino, Italy
A.O. C. Panico, U.O.C Ematologia e Trapianto
Tricase, Italy
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), SOC Clinica Ematologica
Udine, Italy
Ospedale di Circolo - U.O.C Ematologia
Varese, Italy
Biospecimen
1. Peripheral blood and bone marrow aspirate samples previously collected from patient enrolled in FIL\_FOLL12 trial 2. Formalin-fixed paraffin-embedded samples collected from initial diagnosis
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simone Ferrero, MD
SC Ematologia U - AOU Città della Salute e della Scienza di Torino
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2023
First Posted
April 18, 2023
Study Start
September 19, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 1, 2027
Last Updated
December 29, 2025
Record last verified: 2025-09