NCT05816850

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 654 (estimated)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-19
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2023-04-18
• Last updated: 2025-12-29

Locations

26 sites across 1 country: Italy