Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-24 @ 2:46 PM
Study NCT ID:
NCT06781359
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-12-05
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on Plasmablastic Lymphoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069293', 'term': 'Plasmablastic Lymphoma'}], 'ancestors': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Histological and immunohistochemical slides used for the original diagnosis + block'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '36 months', 'description': 'OS is defined as the time from the diagnosis to death for any cause or last clinical contact for censored patients.'}], 'secondaryOutcomes': [{'measure': 'ECOG-PS', 'timeFrame': '36 months', 'description': 'Proportion of Performance Status: from 0 (fully active) to 4 (Completely disabled)'}, {'measure': 'Ann Arbor Stage', 'timeFrame': '36 months', 'description': 'Proportion of stage: from I (better) to IV (worse)'}, {'measure': 'Kidney and/or adrenal gland involvement', 'timeFrame': '36 months', 'description': 'Proportion of the presence of involvement'}, {'measure': 'Diagnostic liquor', 'timeFrame': '36 months', 'description': 'Proportion of the presence of liquor'}, {'measure': 'Splenic involvement', 'timeFrame': '36 months', 'description': 'Proportion of spenic involvement'}, {'measure': 'Type of chemotherapy (CHT) regimen', 'timeFrame': '36 months', 'description': 'Proportion of CHT administered'}, {'measure': 'Complete remission rate (CR)', 'timeFrame': '36 months', 'description': 'CR at the end of treatment'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': '36 monts', 'description': 'ORR is defined as the proportion of patients who have a partial or complete response to therapy'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': '36 months', 'description': 'PFS is defined as time from diagnosis to progression, relapse or death for any cause and last clinical contact for censored cases,'}, {'measure': 'Validation of IPI and CNS-IPI score by means of Cox PH regression on OS and PFS', 'timeFrame': '36 months', 'description': 'IPI (international prognostic Index) ranging from 0 (lower risk) to 5 points (greater risk); CNS-IPI score (Central Nervous System IPI) ranging from 0 (lower risk) to 6 points (greater risk).'}, {'measure': 'Frequencies of HIV and EBV at relapse', 'timeFrame': '36 months', 'description': 'Frequencies of HIV and EBV at relapse'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Plasmablastic lymphoma', 'PBL'], 'conditions': ['Plasmablastic Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is an observational, multicenter, international and retrospective study, that aims to collect data on clinical and pathological characteristics, treatment regimens, outcome, and prognostic factors (clinical, biomarkers and/or radio-metabolic) in patients affected by PBL.', 'detailedDescription': 'This study is an International, multicenter, observational, retrospective trial on patients affected by PBL. The information collected aim to obtain data from the real-life diagnosis, staging, management and treatment and outcome of PBL patients. A centralized pathological review of pathological samples is planned to define the rate of accurate diagnosis and to define a recommended immunohistochemical diagnostic panel for PBL. In addition, exploratory analysis will be performed to better characterize PBL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients (Age ≥ 18 years old) with diagnosis of plasmablastic lymphoma (Histologically confirmed) between Jan 1st 2000, and Dec 31st 2022', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of plasmablastic lymphoma (PBL) between Jan 1st 2000, and Dec 31st 2022\n* Histologically confirmed plasmablastic lymphoma (PBL) diagnosis according to local pathological report\n* Age \\> 18 years old\n* Availability of complete medical records\n* Availability of histopathological material requested by the study\n\nExclusion Criteria:\n\n* Any other histology than PBL\n* Lack of complete medical records\n* Lack of histopathological material requested by the study'}, 'identificationModule': {'nctId': 'NCT06781359', 'acronym': 'FIL_PlaLy', 'briefTitle': 'Study on Plasmablastic Lymphoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Italiana Linfomi - ETS'}, 'officialTitle': 'An International Multicenter Observational Retrospective Study on Plasmablastic Lymphoma Patients', 'orgStudyIdInfo': {'id': 'FIL_PlaLy'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Plasmablastic lymphoma patients', 'description': 'Patients with diagnosis (histologically confirmed) of plasmablastic lymphoma (PBL) between Jan 1st 2000 and Dec 31st 2022'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aviano', 'state': 'PN', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michele Spina, MD', 'role': 'CONTACT', 'email': 'mspina@cro.it'}, {'name': 'Michele Spina, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Centro di Riferimento Oncologico di Aviano, Divisione di Oncologia e dei Tumori immuno-correlati', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'city': 'Ascoli Piceno', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Piero Galieni, MD', 'role': 'CONTACT', 'email': 'piero.galieni@sanita.marche.it'}, {'name': 'Piero Galieni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale C.e G. Mazzoni, U.O.C. di Ematologia', 'geoPoint': {'lat': 42.85351, 'lon': 13.57395}}, {'city': 'Brescia', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandro Re, MD', 'role': 'CONTACT', 'email': 'alessandro.re@asst-spedalicivili.it'}, {'name': 'Alessandro Re, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ASST Spedali Civili di Brescia, Ematologia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Cuneo', 'status': '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': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Nassi, MD', 'role': 'CONTACT', 'email': 'nassil@aou-careggi.toscana.it'}, {'name': 'Luca Nassi, 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': 'Nicla La Verde, MD', 'role': 'CONTACT', 'email': 'nicla.laverde@asst-fbf-sacco.it'}, {'name': 'Nicla La Verde, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ASST -Fatebenefratelli - Polo Luigi Sacco Oncologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Emanuele Ravano, MD', 'role': 'CONTACT', 'email': 'emanuele.ravano@ospedaleniguarda.it'}, {'name': 'Emanuele Ravano, 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': 'Andrés JM Ferreri, Prof', 'role': 'CONTACT', 'email': 'andres.ferreri@hsr.it'}, {'name': 'Andrés JM Ferreri, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Istituto Scientifico San Raffaele, Unità Linfomi - Dipartimento Oncoematologia', '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'}, {'name': 'Francesca Gaia Rossi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda, Ematologia", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Monza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luisa Verga, MD', 'role': 'CONTACT', 'email': 'luisa.verga@irccs-sangerardo.it'}, {'name': 'Luisa Verga, 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 Bruna, MD', 'role': 'CONTACT', 'email': 'riccardo.bruna@maggioreosp.novara.it'}, {'name': 'Riccardo Bruna, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AOU Maggiore della Caritа di Novara, SCDU Ematologia', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Padua', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Greta Scapinello, MD', 'role': 'CONTACT', 'email': 'greta.scapinello@aopd.veneto.it'}, {'name': 'Greta Scapinello, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliera Universitaria di Padova, Ematologia', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Pagani', 'status': 'NOT_YET_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': 'Reggio Emilia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Angela Ferrari, MD', 'role': 'CONTACT', 'email': 'ferrari.angela@ausl.re.it'}, {'name': 'Angela Ferrari, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova, Ematologia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Agostino Tafuri, Prof', 'role': 'CONTACT', 'email': 'agostino.tafuri@ospedalesantandrea.it'}, {'name': 'Agostino Tafuri, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Azienda Ospedaliera Universitaria Sant' Andrea, Ematologia", 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alice Di Rocco, MD', 'role': 'CONTACT', 'email': 'dirocco@bce.uniroma1.it'}, {'name': 'Alice Di Rocco, 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': 'Roma', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefan Hohaus, Prof', 'role': 'CONTACT', 'email': 'stefan.hohaus@Unicatt.it'}, {'name': 'Stefan Hohaus, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitа Cattolica S. Cuore, Ematologia', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Siena', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Emanuele Cencini, MD', 'role': 'CONTACT', 'email': 'cencioema@libero.it'}, {'name': 'Emanuele Cencini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Azienda Ospedaliero Universitaria Senese, U.O.C. Ematologia', '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'}, {'name': 'Federica Cavallo, 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': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Barbara Botto, MD', 'role': 'CONTACT', 'email': 'bbotto@cittadellasalute.to.it'}, {'name': 'Barbara Botto, 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': 'Trento', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Chandrakala Toldo, MD', 'role': 'CONTACT', 'email': 'chandrakala.toldo@apss.tn.it'}, {'name': 'Chandrakala Toldo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale S. Chiara, S.S. di Ematologia', 'geoPoint': {'lat': 46.06787, 'lon': 11.12108}}, {'city': 'Treviso', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Piero Maria Stefani, MD', 'role': 'CONTACT', 'email': 'pieromaria.stefani@aulss2.veneto.it'}, {'name': 'Piero Maria Stefani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "ULSS2 Marca Trevigiana, Ospedale Ca' Foncello, S.C di Ematologia", 'geoPoint': {'lat': 45.66673, 'lon': 12.2416}}, {'city': 'Vicenza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marcello Riva, MD', 'role': 'CONTACT', 'email': 'riva.marcello83@gmail.com'}, {'name': 'Marcello Riva, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ULSS 8 Berica - Ospedale S. Bortolo, Ematologia', 'geoPoint': {'lat': 45.54672, 'lon': 11.5475}}], 'centralContacts': [{'name': 'Uffici Studi FIL', 'role': 'CONTACT', 'email': 'startup@filinf.it', 'phone': '+390131033153'}, {'name': 'Uffici Studi FIL', 'role': 'CONTACT', 'email': 'gestionestudi@filinf.it', 'phone': '+390131033160'}], 'overallOfficials': [{'name': 'Alessia Castellino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UO Ematologia, AO Santa Croce e Carle, Cuneo - Italy'}, {'name': 'Emanuele Ravano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UO Ematologia, Niguarda Grande Ospedale Metropolitano, Milano - Italy.'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': "In compliance with the domestic ethics guideline and applicable legislation, invidual deindentified patients' data underlying the results reported in teh publication article (including study protocol, statistical analysis plan and data coding) can be shared until 5 years after the publication of the present article.", 'ipdSharing': 'YES', 'description': "Qualified researchers may contact the FIL board at segreteriadirezione@filinf.it to share invidual-level patients' clinical data analysed for the publication article (for the avoidance of doubt, no identifiable data, such as name, address, hospital name, date of birth, or any other identifying data, will be shared and should not be requested).", 'accessCriteria': 'For each data sharing request, it is essential that a proforma (available on request) is completed that describes the general purpose, specific aims, data items requested, analysis plan and acknowledgment of the trial management team. Requests will be reviewed based on scientific merit and ethical principles. Requestors who are granted access to the data will be required to complete a data sharing agreement that will be signed by the requester and FIL.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Italiana Linfomi - ETS', 'class': 'OTHER'}, 'collaborators': [{'name': 'AIL Roma - Italia', 'class': 'UNKNOWN'}, {'name': 'AIL Cuneo - Italia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}