Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-24 @ 5:38 PM
Study NCT ID:
NCT06588868
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-09-03
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D009182', 'term': 'Mycosis Fungoides'}, {'id': 'D012751', 'term': 'Sezary Syndrome'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2024-09-03', 'studyFirstSubmitQcDate': '2024-09-05', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.', 'timeFrame': 'The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)', 'description': 'Type of systemic therapies used in real-life settings for the treatment of CTCL according to disease stage.'}, {'measure': 'To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.', 'timeFrame': 'The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)', 'description': 'Frequency of systemic therapies used in real-life settings for the treatment of CTCL according to disease stage.'}, {'measure': 'To evaluate the different systemic treatment approaches in real life settings in patients with CTCL.', 'timeFrame': 'The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)', 'description': 'Evaluation of which systemic therapies are used as first-line compared to which are used as further lines of treatment'}], 'secondaryOutcomes': [{'measure': "To identify real life patients' baseline clinical characteristics (e.g. CTCL subtype, cutaneous, lymphatic and blood involvement (TNMB), staging).", 'timeFrame': 'The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)', 'description': 'Frequency of baseline characteristics.'}, {'measure': 'Evaluate the effectiveness of each different systemic treatment trough evaluation of best ORR attained at any time (ORRb).', 'timeFrame': 'The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)', 'description': 'Estimation of best ORR attained at any time (ORRb) of each line of systemic treatment. Kaplan-Meier estimations of time to next treatment (TTNT) and Progression free survival (PFS) according to each systemic treatment.'}, {'measure': 'Overall Survival of enrolled patients.', 'timeFrame': 'The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)', 'description': 'Overall Survival'}, {'measure': 'Evaluate the safety of each different systemic treatments.', 'timeFrame': 'The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)', 'description': 'Frequency of adverse events collected with the clinical course.'}, {'measure': 'Impact of new drugs (brentuximab vedotin and mogamulizumab).', 'timeFrame': 'The endpoint will be evaluated from the beginning to the end of the study (up to 18 months)', 'description': 'Estimation of best ORR attained at any time (ORRb) of each line of systemic treatment. Kaplan-Meier estimations of time to next treatment (TTNT) and Progression free survival (PFS) according to each systemic treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cutaneous T Cell Lymphoma', 'Mycosis Fungoides', 'Sézary Syndrome', 'Retrospective', 'Systemic therapy', 'Real world'], 'conditions': ['Cutaneous T Cell Lymphoma', 'Cutaneous T-Cell Lymphoma/Mycosis Fungoides', 'Cutaneous T-Cell Lymphoma/Sezary Syndrome']}, 'descriptionModule': {'briefSummary': 'The study is designed to describe the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.', 'detailedDescription': 'The treatment of Mycosis Fungoides (MF)/Sézary Syndrome (SS) is based on a multimodal approach through the involvement of different specialists including hematologists, dermatologists, and radiation therapists. The approach to the treatment combines different skin directed and systemic therapies (such as chemotherapies, immunomodulating agents, immunotherapies).\n\nAlthough there are several well recognized therapies for the treatment of MF/SS, curative therapies are still needed. In this scenario, effective treatments that provide long term responses and disease control are still lacking. Also, International guidelines (EORTC 2017, ESMO 2018, BAD2018, NCCN) report treatment options for the different stages without recommendations of any order due to lack of evidence from clinical trials.\n\nThis study is designed to analyze the different approaches of systemic therapies for the treatment of Cutaneous T-cell Lymphoma in real world setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affected by Cutaneous T-cell Lymphoma who have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2021 in real life settings', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of CTCL according to the EORTC 2017 update criteria1.\n* Age ≥18 years.\n* Have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2023.\n* Availability of complete medical records in order to provide protocol required variables\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Patients not meeting the above-mentioned inclusion criteria.\n* Refuse to sign a written informed consent.'}, 'identificationModule': {'nctId': 'NCT06588868', 'acronym': 'FIL_CTCL', 'briefTitle': 'Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Italiana Linfomi - ETS'}, 'officialTitle': 'Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma: an Observational Retrospective Multicenter Study', 'orgStudyIdInfo': {'id': 'FIL_CTCL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients enrolled', 'description': 'Patients affected by Cutaneous T-cell Lymphoma who have received first dose of a systemic therapy, lasted at least 3 months, between 1 January 2016 and 31 December 2021 in a real life setting.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ancona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Serena Rupoli, MD', 'role': 'CONTACT', 'email': 'serena.rupoli@ospedaliriuniti.marche.it', 'phone': '+390715964771'}, {'name': 'Serena Rupoli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AOU Ospedali Riuniti delle Marche - Clinica di Ematologia', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giacomo Loseto, MD', 'role': 'CONTACT', 'email': 'loseto.giacomo@gmail.com', 'phone': '+390805555415'}, {'name': 'Giacomo Loseto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Istituto Tumori Giovanni Paolo II - U.O.C. Ematologia', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Bari', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Raffaele Filotico, MD', 'role': 'CONTACT', 'email': 'raffaele.filotico@uniba.it'}, {'name': 'Raffaele Filotico, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O.C. Dermatologia e Venereologia Universitaria - A.O.U. Policlinico Consorziale', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pier Luigi Zinzani, MD', 'role': 'CONTACT', 'email': 'pierluigi.zinzani@unibo.it', 'phone': '+390512144042'}, {'name': 'Pier Luigi Zinzani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Policlinico S.Orsola-Malpighi - Istituto di Ematologia', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Brescia', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandra Tucci, MD', 'role': 'CONTACT', 'email': 'alessandra.tucci@asst-spedalicivili.it', 'phone': '+390303995438'}], 'facility': 'ASST Spedali Civili di Brescia - S.C. Ematologia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Cagliari', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniela Dessi, MD', 'role': 'CONTACT', 'email': 'daniela.dessi@aob.it', 'phone': '+3907052965371'}, {'name': 'Daniela Dessi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O. Brotzu Ospedale Businco - S.C. Ematologia e CTMO', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'city': 'Catania', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Amalia Figuera, MD', 'role': 'CONTACT', 'email': 'amaliafiguera@gmail.com', 'phone': '+390957436155'}, {'name': 'Amalia Figuera, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U. Policlinico S. Marco - U.O.C. di Ematologia', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Benedetta Sordi, MD', 'role': 'CONTACT', 'email': 'benedetta.sordi@unifi.it'}, {'name': 'Benedetta Sordi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cesare Massone, MD', 'role': 'CONTACT', 'email': 'cesare.massone@galliera.it'}, {'name': 'Cesare Massone, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'S.C. Dermatologia - E.O. Galliera', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Onida, MD', 'role': 'CONTACT', 'email': 'francesco.onida@asst-fbf-sacco.it'}, {'name': 'Francesco Onida, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oncoematologia - ASST Fatebenefratelli - Sacco', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Silvia Alberti Violetti, MD', 'role': 'CONTACT', 'email': 'silvia.alberti@unimi.it'}, {'name': 'Silvia Alberti Violetti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "U.O.C. Dermatologia - Ospedale Maggiore Policlinico Fondazione IRCCS Ca' Granda", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Padua', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mauro Salvatore Alaibac, MD', 'role': 'CONTACT', 'email': 'mauro.alaibac@unipd.it'}, {'name': 'Mauro Salvatore Ailaibac, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O.C. Clinica Dermatologica - A.O.U. di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'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': 'U.O.C Ematologia 1 - IRCCS Fondazione Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Miriam Teoli, MD', 'role': 'CONTACT', 'email': 'miriam.teoli@ifo.it', 'phone': '+390652662825'}, {'name': 'Miriam Teoli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS I.F.O. San Gallicano - UOSD Porfirie e Malattie Rare', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Cantonetti, MD', 'role': 'CONTACT', 'email': 'm.cantonetti@idi.it'}, {'name': 'Maria Cantonetti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Skin Cancer Center - IRCCS Istituto Dermopatico dell'Immacolata", 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Siena', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elisa Cinotti, MD', 'role': 'CONTACT', 'email': 'elisa.cinotti@unisi.it'}, {'name': 'Elisa Cinotti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'U.O.C. Dermatologia - A.O.U. Senese', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pietro Quaglino, MD', 'role': 'CONTACT', 'email': 'pietro.quaglino@unito.it', 'phone': '+390116335843'}, {'name': 'Pietro Quaglino, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U. Città della Salute e della Scienza di Torino - S.C. Dermatologia U', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Andrea Bernardelli, MD', 'role': 'CONTACT', 'email': 'andrea.bernardelli@aovr.veneto.it', 'phone': '+390458124797'}, {'name': 'Andrea Bernardelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U.I. di Verona - U.O.C. 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': 'Pietro Quaglino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SC Dermatologia U - A.O.U. Città della Salute e della Scienza di Torino'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Italiana Linfomi - ETS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Takeda', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}