Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-16 @ 8:36 AM
Study NCT ID:
NCT06588205
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2024-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring the Clinical Impact of MYC Aberrations and Their Relationship With Microenvironment in Diffuse Large B Cell Lymphoma and High-Grade B Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2024-09-02', 'studyFirstSubmitQcDate': '2024-09-04', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the histopathological, genetic, clinical characteristics and outcome of patients with DLBCL or HGBCL with MYC rearrangements or GCN (alone or in association with BCL2 and BCL6) treated with curative intent therapy', 'timeFrame': 'The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)', 'description': 'Comparison of Progression Free Survival (PFS) according to genetic subgroups with or without intensified treatment'}], 'secondaryOutcomes': [{'measure': 'Identify biological relationship between MYC aberration, gene mutations and patterns of immune microenvironment in B-cell lymphomas with DLBCL or high-grade morphology', 'timeFrame': 'The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)', 'description': '% of patients with presence of MYC, BCL2 and/or BCL6 translocation evaluated by FISH'}, {'measure': 'Identify biological relationship between MYC aberration, gene mutations and patterns of immune microenvironment in B-cell lymphomas with DLBCL or high-grade morphology', 'timeFrame': 'The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)', 'description': '% of patients with presence of MYC gain of copy (GCN: \\> 3 copies in more than 30% of the nuclei) evaluated by FISH'}, {'measure': 'Identify biological relationship between MYC aberration, gene mutations and patterns of immune microenvironment in B-cell lymphomas with DLBCL or high-grade morphology', 'timeFrame': 'The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)', 'description': '% of patient with presence of MYC amplification evaluated by FISH'}, {'measure': 'Identify putative prognostic and predictive biomarkers related to the lymphoma microenvironment', 'timeFrame': 'The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)', 'description': 'Correlation between the microenvironment signature and patient Overall Survival (OS)'}, {'measure': 'Analyze the impact of the type of therapy, standard or intensified (with or without autotransplantation), on the outcome in the different subgroups of patients', 'timeFrame': 'The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)', 'description': 'Progression Free Survival comparison in the different subgroups of lymphomas and according to the type of treatment received'}, {'measure': 'Assess the risk of central nervous system (CNS) recurrence and the impact of prophylaxis performed with intrathecal chemotherapy vs methotrexate intravenous', 'timeFrame': 'The endpoint will be evaluated from the beginning to the end of the study (up to 36 months)', 'description': 'Progression Free Survival comparison in the different subgroups of lymphomas and according to the type of treatment received'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diffuse Large B Cell Lymphoma', 'High-grade B-cell Lymphoma', 'MYC', 'BCL2', 'BCL6', 'Double Hit', 'Triple Hit', 'lymphoma micro-environment'], 'conditions': ['Diffuse Large B Cell Lymphoma', 'High-grade B-cell Lymphoma', 'High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements']}, 'descriptionModule': {'briefSummary': 'This is a observational, retrospective and prospective study designed to assess the potential correlations between MYC alterations, lymphoma mutational landscape and functional immune contextures in Diffuse Large B-cell Lymphoma or High-Grade B-cell Lymphoma', 'detailedDescription': 'Diffuse large B-cell lymphomas (DLBCL) and high-grade B-cell lymphomas (HGBCL) are a group of heterogeneous diseases representing more than a third of lymphomas in adults. 5-years overall survival of patients affected by DLBCL and HGBCL is around 70-60% and efficient prognostic markers are warranted to improve patients\' survival by better tailored therapeutical approaches.\n\nGenetic rearrangements of the MYC gene occur in 5-10% of DLBCL at diagnosis, and the presence of double translocations involving both MYC and BCL2 ("double-hit", DH), associated or not with BCL6 ("triple-hit", TH) translocation, is associated with unfavorable prognostic impact.\n\nIntensification of treatment compared to standard chemotherapy (R-CHOP) appears to reduce the risk of recurrence in patients with DH or TH lymphomas, but a survival advantage has not been demonstrated.\n\nNumerical changes in MYC (gain of copy number, GCN) may also affect the outcome of patients with DLBCL, but their prognostic relevance and the benefit of treatment intensification is still controversial.\n\nAdditionally, novel scientific evidence indicates a contribution of lymphoma micro-environment (LME) in disease genomic subtype and patient prognosis.\n\nWe aimed this study at investigating potential biological links between MYC aberrations, lymphoma mutational landscape and functional immune contextures in DLBCL and HGBCL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient affected by DLBCL or HGBL with MYC alterations treated with standard R-chemotherapy regimens as first line treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of nodal and extranodal Diffuse Large B Cell Lymphoma, High Grade B Cell Lymphomas (including low-grade transformed lymphomas; double and triple hit; 11q aberration; not otherwise specified) after 1st January 2019\n* Presence of one MYC translocation or gain of copies (GCN: \\> 3 copies in more than 30% of the nuclei) or amplification evaluated by FISH\n* Availability of immunohistochemical analysis of CD10, Bcl6, MUM1, Bcl2, Myc, Ki67\n* Have received curative treatment (e.g. R-CHOP, R DA EPOCH, intensified "Burkitt like" chemotherapies) as first-line therapy\n* Histological material of adequate size and quality to perform histological review with any additional investigations (immunohistochemistry, FISH and other molecular analysis). A FFPE block must be provided for patient enrollment.\n* Age between 18 and 79 years\n\nExclusion Criteria:\n\n* Primary lymphomas of the central nervous system, plasmablastic lymphoma, Burkitt\'s lymphoma, primary mediastinal B lymphoma\n* Have received palliative treatment'}, 'identificationModule': {'nctId': 'NCT06588205', 'acronym': 'FIL_MIMYC', 'briefTitle': 'Exploring the Clinical Impact of MYC Aberrations and Their Relationship With Microenvironment in Diffuse Large B Cell Lymphoma and High-Grade B Cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Italiana Linfomi - ETS'}, 'officialTitle': 'Multicenter, Observational, Retrospective-prospective Study Exploring the Clinical Impact of MYC Aberrations and Their Relationship With Microenvironment in Diffuse Large B Cell Lymphoma and High-Grade B Cell Lymphoma', 'orgStudyIdInfo': {'id': 'FIL_MIMYC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients enrolled', 'description': 'Patient affected by DLBCL or HGBL with MYC alterations treated with standard R-chemotherapy regimens as first line treatment'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alessandria', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Manuela Zanni, MD', 'role': 'CONTACT', 'email': 'manuela.zanni@ospedale.al.it', 'phone': '+390131206156'}, {'name': 'Manuela Zanni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U. SS. Antonio e Biagio e C. Arrigo - S.C.D.U. Ematologia', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'city': 'Ancona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Guido Gini, MD', 'role': 'CONTACT', 'email': 'guido.gini@ospedaliriuniti.marche.it', 'phone': '+390715964562'}, {'name': 'Guido Gini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U. Ospedali Riuniti delle Marche - Clinica di Ematologia', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sabino Ciavarella, MD', 'role': 'CONTACT', 'email': 'sabinociavarella@yahoo.it', 'phone': '+390805555408'}, {'name': 'Sabino Ciavarella, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'I.R.C.C.S. Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Brescia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Chiara Pagani, MD', 'role': 'CONTACT', 'email': 'chiara.pagani@asst-spedalicivili.it', 'phone': '+390303996269'}, {'name': 'Chiara Pagani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ASST Spedali Civili - S.C. Ematologia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Candiolo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Valentina Sangiorgio, MD', 'role': 'CONTACT', 'email': 'fabiola.sangiorgio@gmail.com', 'phone': '+390119933947'}, {'name': 'Valentina Sangiorgio, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'I.R.C.C.S. Istituto di Candiolo - FPO', 'geoPoint': {'lat': 44.95858, 'lon': 7.59812}}, {'city': 'Castelfranco Veneto', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mariella Lo Schirico, MD', 'role': 'CONTACT', 'email': 'mariella.loschirico@iov.veneto.it', 'phone': '+390432732344'}, {'name': 'Mariella Lo Schirico, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncoematologia', 'geoPoint': {'lat': 45.67146, 'lon': 11.92755}}, {'city': 'Catania', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ugo Consoli, MD', 'role': 'CONTACT', 'email': 'ugo.consoli144@gmail.com', 'phone': '+390957595055'}, {'name': 'Ugo Consoli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ARNAS Garibaldi - U.O.C. Ematologia', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Civitanova Marche', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Caterina Bocci, MD', 'role': 'CONTACT', 'email': 'cate.bocci@gmail.com', 'phone': '+3907332572467'}, {'name': 'Caterina Bocci, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.S.T. Macerata - U.O.S.D Ematologia', 'geoPoint': {'lat': 43.30491, 'lon': 13.72068}}, {'city': 'Florence', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Benedetta Sordi, MD', 'role': 'CONTACT', 'email': 'benedetta.sordi@unifi.it', 'phone': '+390557946445'}, {'name': 'Benedetta Sordi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Emanuele Ravano, MD', 'role': 'CONTACT', 'email': 'emanuele.ravano@ospedaleniguarda.it', 'phone': '+390264442668'}, {'name': 'Emanuele Ravano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ASST Grande Ospedale Metropolitano Niguarda - S.C. Ematologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesca Gaia Rossi, MD', 'role': 'CONTACT', 'email': 'francescagaia.rossi@policlinico.mi.it', 'phone': '+390255033466'}, {'name': 'Francesca Gaia Rossi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda - S.C. Ematologia", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Padua', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Greta Scapinello, MD', 'role': 'CONTACT', 'email': 'greta.scapinello@aopd.veneto.it', 'phone': '+390498217809'}, {'name': 'Greta Scapinello, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U. di Padova - U.O.C. Ematologia', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Padua', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Dario Marino, MD', 'role': 'CONTACT', 'email': 'dario.marino@iov.veneto.it', 'phone': '+390498215621'}, {'name': 'Dario Marino, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'I.R.C.C.S. Istituto Oncologico Veneto - U.O.C. Oncologia 1', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Sassuolo', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Sara Bigliardi, MD', 'role': 'CONTACT', 'email': 's.bigliardi@ausl.mo.it', 'phone': '+390536846162'}, {'name': 'Sara Bigliardi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AUSL Modena sede di Sassuolo - UOSD di Oncologia Area Sud', 'geoPoint': {'lat': 44.5432, 'lon': 10.7848}}, {'city': 'Siena', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alberto Fabbri, MD', 'role': 'CONTACT', 'email': 'fabbri7@unisi.it'}, {'name': 'Alberto Fabbri, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O.C. Ematologia - A.O.U. Senese', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'city': 'Torino', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Federica Cavallo, MD', 'role': 'CONTACT', 'email': 'f.cavallo@unito.it', 'phone': '+390116334264'}, {'name': 'Federica Cavallo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U. Città della Salute e della Scienza di Torino - S.C. Ematologia U', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Treviso', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Piero Maria Stefani, MD', 'role': 'CONTACT', 'email': 'pieromaria.stefani@aulss2.veneto.it', 'phone': '+390422322221'}, {'name': 'Piero Maria Stefani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "ULSS 2 Ospedale Ca' Foncello - U.O.C. Ematologia", 'geoPoint': {'lat': 45.66673, 'lon': 12.2416}}, {'city': 'Tricase', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Mele, MD', 'role': 'CONTACT', 'email': 'sperimentazionicliniche@piafondazionepanico.it', 'phone': '+390833773111'}, {'name': 'Anna Mele, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O. Cardinale "G. Panico" - U.O.C Ematologia e Trapianto Midollo Osseo', 'geoPoint': {'lat': 39.93018, 'lon': 18.35421}}, {'city': 'Trieste', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elisa Lucchini, MD', 'role': 'CONTACT', 'email': 'elisa.lucchini@asugi.sanita.fvg.it', 'phone': '+390403992677'}, {'name': 'Elisa Lucchini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.S.U. Giuliano Isontina - S.C. Ematologia', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'city': 'Verona', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesca Maria Quaglia, MD', 'role': 'CONTACT', 'email': 'francescamaria.quaglia@aovr.veneto.it', 'phone': '+390458124827'}, {'name': 'Francesca Maria Quaglia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U.I. di Verona - Ematologia', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], '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': 'Luisa Lorenzi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SC Anatomia Patologica - ASST Spedali Civili di Brescia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Italiana Linfomi - ETS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}