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

ConditionFollicular Lymphoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Italiana Linfomi - ETS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

None

Trial population

Patient affected by advanced Follicular Lymphoma treated with immunochemotherapy in the FIL\_FOLL12 trial

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • 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

Treatment groups

654 Participants
are divided into 1 treatment group
Group A: Patients enrolled2 interventions

Trial outcomes

Primary outcomes

1

Progression free survival

Time between the treatment start and the first documentation of recurrence, progression or death from any cause

Time frame
From treatment start up to 43 months

Secondary outcomes

1

Response rate

Response rate (complete metabolic response/minimal residual disease (MRD) negativity) at the end of induction.

Time frame
From treatment start to 7 months (R-Bendamustine) or from treatment start to 5,6 months (R-CHOP)
2

Concordance between EZH2 gene mutations/gains and EZH2-related gene expression signature

Concordance between EZH2 gene mutations/gains and EZH2-related gene expression signature

Time frame
Before treatment start

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Italiana Linfomi - ETS

Lead sponsor

Source ClinicalTrials.gov
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