Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-28 @ 8:28 AM
Study NCT ID:
NCT05816850
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2023-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multilayer Biological Characterization of Advanced Follicular Lymphoma: a Translational Study From FIL_FOLL12 Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '1. Peripheral blood and bone marrow aspirate samples previously collected from patient enrolled in FIL\\_FOLL12 trial\n2. Formalin-fixed paraffin-embedded samples collected from initial diagnosis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 654}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2023-04-04', 'studyFirstSubmitQcDate': '2023-04-04', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'From treatment start up to 43 months', 'description': 'Time between the treatment start and the first documentation of recurrence, progression or death from any cause'}], 'secondaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'From treatment start to 7 months (R-Bendamustine) or from treatment start to 5,6 months (R-CHOP)', 'description': 'Response rate (complete metabolic response/minimal residual disease (MRD) negativity) at the end of induction.'}, {'measure': 'Concordance between EZH2 gene mutations/gains and EZH2-related gene expression signature', 'timeFrame': 'Before treatment start', 'description': 'Concordance between EZH2 gene mutations/gains and EZH2-related gene expression signature'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphoma', 'Follicular', 'Immunochemotherapy', 'FL', 'Aberration', 'Mutation', 'EZH2', 'CHOP', 'Bendamustine', 'Biological', 'Rituximab', 'Biomarker'], 'conditions': ['Follicular Lymphoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nEZH2 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).\n\nThe 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.\n\nThe 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).\n\nMoreover, to implement an Italian network of laboratories able to provide these translational outputs within a rapid turnaround time.\n\nFinally, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient affected by advanced Follicular Lymphoma treated with immunochemotherapy in the FIL\\_FOLL12 trial', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient enrolled in the FIL\\_FOLL12 trial (documented by the signature of the study informed consent);\n* Availability of biological samples: bone marrow aspirate, peripheral blood and/or FFPE diagnostic sample (nodal or extranodal);\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05816850', 'acronym': 'FIL_FOLL-BIO', 'briefTitle': 'Multilayer Biological Characterization of Advanced Follicular Lymphoma: a Translational Study From FIL_FOLL12 Trial', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Italiana Linfomi - ETS'}, 'officialTitle': 'Multilayer Biological Characterization of Advanced Follicular Lymphoma: a Translational Study From FIL_FOLL12 Trial', 'orgStudyIdInfo': {'id': 'FIL_FOLL-BIO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients enrolled', 'description': 'Patient affected by advanced Follicular Lymphoma treated with immunochemotherapy in the FIL\\_FOLL12 trial', 'interventionNames': ['Diagnostic Test: EZH2 mutations/CNAs by droplet digital PCR (ddPCR)', 'Diagnostic Test: EZH2-derived gene expression signature by RNA-Seq']}], 'interventions': [{'name': 'EZH2 mutations/CNAs by droplet digital PCR (ddPCR)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Test of EZH2 mutations/CNAs by droplet digital PCR (ddPCR) in peripheral blood and in unsorted bone marrow aspirate samples at enrolment', 'armGroupLabels': ['Patients enrolled']}, {'name': 'EZH2-derived gene expression signature by RNA-Seq', 'type': 'DIAGNOSTIC_TEST', 'description': 'Test of EZH2-derived gene expression signature by RNA-Seq in a subset of diagnostic FFPE samples', 'armGroupLabels': ['Patients enrolled']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alessandria', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Manuela Zanni, MD', 'role': 'CONTACT', 'email': 'manuela.zanni@ospedale.al.it'}, {'name': 'Manuela Zanni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'city': 'Biella', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Annarita Conconi, MD', 'role': 'CONTACT', 'email': 'annarita.conconi@aslbi.piemonte.it'}, {'name': 'Annarita Conconi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nuovo Ospedale degli Infermi, SSD Ematologia', 'geoPoint': {'lat': 45.56304, 'lon': 8.05796}}, {'city': 'Brescia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonella Anastasia, MD', 'role': 'CONTACT', 'email': 'antonella.anastasia@gmail.com'}, {'name': 'Antonella Anastasia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ASST Spedali Civili di Brescia - Ematologia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Catania', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Annalisa Chiarenza, MD', 'role': 'CONTACT', 'email': 'annalisa.chiarenza@gmail.com'}, {'name': 'Annalisa Chiarenza, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera Universitaria Policlinico - S. Marco, UOC di Ematologia', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Cuneo', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Claudia Castellino, MD', 'role': 'CONTACT', 'email': 'castellino.c@ospedale.cuneo.it'}, {'name': 'Claudia Castellino, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O. S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'city': 'Florence', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Benedetta Puccini, MD', 'role': 'CONTACT', 'email': 'puccinib@aou-careggi.toscana.it'}, {'name': 'Benedetta Puccini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Chiara Ghiggi, MD', 'role': 'CONTACT', 'email': 'chiara.ghiggi@hsanmartino.it'}, {'name': 'Chiara Ghiggi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia, Ematologia e terapie cellulari", 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Meldola', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gerardo Musuraca, MD', 'role': 'CONTACT', 'email': 'gerardo.musuraca@irst.emr.it'}, {'name': 'Gerardo Musuraca, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST S.R.L., Ematologia', 'geoPoint': {'lat': 44.12775, 'lon': 12.0626}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vittorio Ruggero Zilioli, MD', 'role': 'CONTACT', 'email': 'vittorioruggero.zilioli@ospedaleniguarda.it'}, {'name': 'Vittorio Ruggero Zilioli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Paolo Corradini, MD', 'role': 'CONTACT', 'email': 'paolo.corradini@unimi.it'}, {'name': 'Paolo Corradini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Ematologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Modena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessia Bari, MD', 'role': 'CONTACT', 'email': 'alessia.bari@unimore.it'}, {'name': 'Alessia Bari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero-Universitaria Policlinico di Modena, U.O. Oncologia', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Monza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Silvia Bolis, MD', 'role': 'CONTACT', 'email': 'silviaanna.bolis@irccs-sangerardo.it'}, {'name': 'Silvia Bolis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione IRCCS San Gerardo dei Tintori - Ematologia', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'city': 'Novara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Riccardo Moia, MD', 'role': 'CONTACT', 'email': 'riccardo.moia@uniupo.it'}, {'name': 'Riccardo Moia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AOU Maggiore della Carità di Novara, SCDU Ematologia', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Pagani', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Catello Califano, MD', 'role': 'CONTACT', 'email': 'c.califano@aslsalerno.it'}, {'name': 'Catello Califano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Presidio ospedaliero "A. Tortora", U.O. Onco-ematologia', 'geoPoint': {'lat': 40.74199, 'lon': 14.61448}}, {'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Caterina Patti, MD', 'role': 'CONTACT', 'email': 'k.patti@villasofia.it'}, {'name': 'Caterina Patti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O. Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Pavia', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Arcaini, MD', 'role': 'CONTACT', 'email': 'luca.arcaini@unipv.it'}, {'name': 'Luca Arcaini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Policlinico S. Matteo di Pavia, Divisione di Ematologia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Piacenza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Annalisa Arcari, MD', 'role': 'CONTACT', 'email': 'a.arcari@ausl.pc.it'}, {'name': 'Annalisa Arcari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Guglielmo da Saliceto, U.O. Ematologia', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}, {'city': 'Reggio Calabria', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Caterina Stelitano, MD', 'role': 'CONTACT', 'email': 'caterinastelitano27@gmail.com'}, {'name': 'Caterina Stelitano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'city': 'Rimini', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Melania Celli, MD', 'role': 'CONTACT', 'email': 'melania.celli@auslromagna.it'}, {'name': 'Melania Celli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale degli Infermi di Rimini, U.O. di Ematologia', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ilaria Del Giudice, MD', 'role': 'CONTACT', 'email': 'ilaria.delgiudice@uniroma1.it'}, {'name': 'Ilaria Del Giudice, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Policlinico Umberto I - Università "La Sapienza", Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Rozzano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesca Ricci, MD', 'role': 'CONTACT', 'email': 'francesca.ricci@humanitas.it'}, {'name': 'Francesca Ricci, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Clinico Humanitas, U.O. Ematologia', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Simone Ferrero, MD', 'role': 'CONTACT', 'email': 'simone.ferrero@unito.it'}, {'name': 'Simone Ferrero, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U. Città della Salute e della Scienza di Torino, Ematologia Universitaria', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carola Boccomini, MD', 'role': 'CONTACT', 'email': 'cboccomini@cittadellasalute.to.it'}, {'name': 'Carola Boccomini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U. Città della Salute e della Scienza di Torino, S.C. Ematologia', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Tricase', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Vincenzo Pavone, MD', 'role': 'CONTACT', 'email': 'salentoematologia@piafondazionepanico.it'}, {'name': 'Vincenzo Pavone, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O. C. Panico, U.O.C Ematologia e Trapianto', 'geoPoint': {'lat': 39.93018, 'lon': 18.35421}}, {'city': 'Udine', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Jacopo Olivieri, MD', 'role': 'CONTACT', 'email': 'jacopo.olivieri@asufc.sanita.fvg.it'}, {'name': 'Jacopo Olivieri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), SOC Clinica Ematologica', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'city': 'Varese', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele Merli, MD', 'role': 'CONTACT', 'email': 'michele.merli@asst-settelaghi.it'}, {'name': 'Michele Merli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale di Circolo - U.O.C Ematologia', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}], 'centralContacts': [{'name': 'Uffici Studi FIL', 'role': 'CONTACT', 'email': 'startup@filinf.it', 'phone': '+390131033153'}, {'name': 'Uffici Studi FIL', 'role': 'CONTACT', 'email': 'gestionestudi@filinf.it', 'phone': '+390599769913'}], 'overallOfficials': [{'name': 'Simone Ferrero, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SC Ematologia U - AOU Città della Salute e della Scienza di Torino'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Italiana Linfomi - ETS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}