Evaluating biomarkers in advanced follicular lymphoma treatment
Multilayer Biological Characterization of Advanced Follicular Lymphoma: a Translational Study From FIL_FOLL12 Trial
This study is trying to see if certain genetic changes in patients with advanced follicular lymphoma can help doctors choose the best chemotherapy treatment after they've received immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 654 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Italiana Linfomi - ETS Academic / other |
| Drugs / interventions | rituximab, chemotherapy, immunotherapy |
| Locations | 26 sites (Alessandria and 25 other locations) |
| Trial ID | NCT05816850 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the role of EZH2 aberrations in patients with advanced follicular lymphoma (FL) who have been treated with immunochemotherapy. It utilizes biological samples collected from the FIL_FOLL12 trial, which enrolled 807 patients, to validate the predictive value of EZH2 mutations and guide treatment decisions between different chemotherapy regimens. Additionally, the study will explore novel biomarkers related to FL heterogeneity and establish a network of laboratories in Italy for rapid biomarker analysis.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who were enrolled in the FIL_FOLL12 trial and have available biological samples.
Not a fit: Patients who are not enrolled in the FIL_FOLL12 trial or do not have the required biological samples will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clinicians with valuable biomarkers to tailor chemotherapy choices, potentially improving patient outcomes in advanced follicular lymphoma.
How similar studies have performed: Other studies have shown promise in utilizing biomarkers for treatment personalization in lymphoma, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Alessandria and 25 other locations
- A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia — Alessandria, Italy (Recruiting)
- Nuovo Ospedale degli Infermi, SSD Ematologia — Biella, Italy (Recruiting)
- ASST Spedali Civili di Brescia - Ematologia — Brescia, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Policlinico - S. Marco, UOC di Ematologia — Catania, Italy (Recruiting)
- A.O. S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo — Cuneo, Italy (Not_yet_recruiting)
- Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia — Florence, Italy (Not_yet_recruiting)
- Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia, Ematologia e terapie cellulari — Genova, Italy (Recruiting)
- IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST S.R.L., Ematologia — Meldola, Italy (Recruiting)
- ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia — Milan, Italy (Recruiting)
- Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Ematologia — Milan, Italy (Recruiting)
- Azienda Ospedaliero-Universitaria Policlinico di Modena, U.O. Oncologia — Modena, Italy (Recruiting)
- Fondazione IRCCS San Gerardo dei Tintori - Ematologia — Monza, Italy (Recruiting)
- AOU Maggiore della Carità di Novara, SCDU Ematologia — Novara, Italy (Recruiting)
- Presidio ospedaliero "A. Tortora", U.O. Onco-ematologia — Pagani, Italy (Recruiting)
- A.O. Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia — Palermo, Italy (Recruiting)
- IRCCS Policlinico S. Matteo di Pavia, Divisione di Ematologia — Pavia, Italy (Not_yet_recruiting)
- Ospedale Guglielmo da Saliceto, U.O. Ematologia — Piacenza, Italy (Recruiting)
- Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia — Reggio Calabria, Italy (Not_yet_recruiting)
- Ospedale degli Infermi di Rimini, U.O. di Ematologia — Rimini, Italy (Not_yet_recruiting)
- Policlinico Umberto I - Università "La Sapienza", Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione — Roma, Italy (Recruiting)
- Istituto Clinico Humanitas, U.O. Ematologia — Rozzano, Italy (Recruiting)
- A.O.U. Città della Salute e della Scienza di Torino, Ematologia Universitaria — Torino, Italy (Recruiting)
- A.O.U. Città della Salute e della Scienza di Torino, S.C. Ematologia — Torino, Italy (Recruiting)
- A.O. C. Panico, U.O.C Ematologia e Trapianto — Tricase, Italy (Not_yet_recruiting)
- Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), SOC Clinica Ematologica — Udine, Italy (Recruiting)
- Ospedale di Circolo - U.O.C Ematologia — Varese, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Simone Ferrero, MD — SC Ematologia U - AOU Città della Salute e della Scienza di Torino
- Study coordinator: Uffici Studi FIL
- Email: startup@filinf.it
- Phone: +390131033153
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.