Multilayer Biological Characterization of Advanced Follicular Lymphoma: a Translational Study From FIL_FOLL12 Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EZH2 mutations/CNAs by droplet digital PCR (ddPCR), EZH2-derived gene expression signature by RNA-Seq.
- Who it may be relevant to
- Registry conditions: Follicular Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test 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 - 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
Primary outcome measures
- Progression free survival [Time frame: From treatment start up to 43 months]
Secondary outcome measures (2)
- Response rate [Time frame: 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 [Time frame: Before treatment start]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 26 centers
- A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia — Alessandria
- Nuovo Ospedale degli Infermi, SSD Ematologia — Biella
- ASST Spedali Civili di Brescia - Ematologia — Brescia
- Azienda Ospedaliera Universitaria Policlinico - S. Marco, UOC di Ematologia — Catania
- A.O. S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo — Cuneo
- Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia — Florence
- Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia, Ematologia e terapie ce — Genova
- IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST S.R.L., Ematologia — Meldola
- … and 18 more centers
Identifiers
NCT: NCT05816850 · FIL_FOLL-BIO