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

Sponsor
Fondazione Italiana Linfomi - ETS
Study ID
NCT05816850
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EZH2 mutations/CNAs by droplet digital PCR (ddPCR) — DIAGNOSTIC_TEST
    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 — DIAGNOSTIC_TEST
    Test of EZH2-derived gene expression signature by RNA-Seq in a subset of diagnostic FFPE samples

Study Details

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.

Key Dates

First listed
Apr 18, 2023
Start date
Sep 19, 2023
Status verified
Sep 2025
Primary completion
Dec 1, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
654 participants (estimated)

Arms

  • Arm: Patients enrolled
    Patient affected by advanced Follicular Lymphoma treated with immunochemotherapy in the FIL\_FOLL12 trial

Primary Outcome Measure

Progression free survival [ Time Frame: From treatment start up to 43 months ]

Central Contacts

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