Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 6:28 PM
Study NCT ID:
NCT06024694
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-26
First Post:
2022-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Mediastinal Large B-cell Lymphoma With CNS Involvement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-06-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2022-08-24', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical characteristics 1', 'timeFrame': '2 YEARS', 'description': 'to describe the PMLBCL characteristics at diagnosis and at CNS relapse ( first relapse or second and subsequent recurrences) and the treatment received to describe the median time to CNS relapse to define prognostic factors of outcome of CNS relapse in PMLBCL patients'}, {'measure': 'Clinical characteristics 2', 'timeFrame': '2 YEARS', 'description': 'to correlate treatment strategy with survival end-points'}, {'measure': 'Clinical characteristics 3', 'timeFrame': '2 YEARS', 'description': 'to evaluate the Progression Free Survical ( PFS) after CNS events'}, {'measure': 'Clinical characteristics 4', 'timeFrame': '2 YEARS', 'description': 'to evaluate Overall Survival ( OS) after CNS relapse to centra! pathological reviewed the initial diagnosis and the relapse and to correlate biological and molecular factors with CNS recurrence'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CNS', 'PMLBCL'], 'conditions': ['Primary Mediastinal Large B-cell Lymphoma (PMBCL)']}, 'referencesModule': {'references': [{'pmid': '8669537', 'type': 'BACKGROUND', 'citation': 'Cazals-Hatem D, Lepage E, Brice P, Ferrant A, d\'Agay MF, Baumelou E, Briere J, Blanc M, Gaulard P, Biron P, Schlaifer D, Diebold J, Audouin J. Primary mediastinal large B-cell lymphoma. A clinicopathologic study of 141 cases compared with 916 nonmediastinal large B-cell lymphomas, a GELA ("Groupe d\'Etude des Lymphomes de l\'Adulte") study. Am J Surg Pathol. 1996 Jul;20(7):877-88. doi: 10.1097/00000478-199607000-00012.'}, {'pmid': '7539625', 'type': 'BACKGROUND', 'citation': 'Falini B, Venturi S, Martelli M, Santucci A, Pileri S, Pescarmona E, Giovannini M, Mazza P, Martelli MF, Pasqualucci L, et al. Mediastinal large B-cell lymphoma: clinical and immunohistological findings in 18 patients treated with different third-generation regimens. Br J Haematol. 1995 Apr;89(4):780-9. doi: 10.1111/j.1365-2141.1995.tb08415.x.'}, {'pmid': '26980727', 'type': 'BACKGROUND', 'citation': 'Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, Advani R, Ghielmini M, Salles GA, Zelenetz AD, Jaffe ES. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15.'}, {'pmid': '10561312', 'type': 'BACKGROUND', 'citation': 'Bishop PC, Wilson WH, Pearson D, Janik J, Jaffe ES, Elwood PC. CNS involvement in primary mediastinal large B-cell lymphoma. J Clin Oncol. 1999 Aug;17(8):2479-85. doi: 10.1200/JCO.1999.17.8.2479.'}, {'pmid': '12495899', 'type': 'BACKGROUND', 'citation': 'Zinzani PL, Martelli M, Bertini M, Gianni AM, Devizzi L, Federico M, Pangalis G, Michels J, Zucca E, Cantonetti M, Cortelazzo S, Wotherspoon A, Ferreri AJ, Zaja F, Lauria F, De Renzo A, Liberati MA, Falini B, Balzarotti M, Calderoni A, Zaccaria A, Gentilini P, Fattori PP, Pavone E, Angelopoulou MK, Alinari L, Brugiatelli M, Di Renzo N, Bonifazi F, Pileri SA, Cavalli F; International Extranodal Lymphoma Study Group (IELSG). Induction chemotherapy strategies for primary mediastinal large B-cell lymphoma with sclerosis: a retrospective multinational study on 426 previously untreated patients. Haematologica. 2002 Dec;87(12):1258-64.'}, {'pmid': '28318892', 'type': 'BACKGROUND', 'citation': 'Martelli M, Ferreri A, Di Rocco A, Ansuinelli M, Johnson PWM. Primary mediastinal large B-cell lymphoma. Crit Rev Oncol Hematol. 2017 May;113:318-327. doi: 10.1016/j.critrevonc.2017.01.009. Epub 2017 Jan 21.'}, {'pmid': '25216682', 'type': 'BACKGROUND', 'citation': 'Aoki T, Izutsu K, Suzuki R, Nakaseko C, Arima H, Shimada K, Tomita A, Sasaki M, Takizawa J, Mitani K, Igarashi T, Maeda Y, Fukuhara N, Ishida F, Niitsu N, Ohmachi K, Takasaki H, Nakamura N, Kinoshita T, Nakamura S, Ogura M. Prognostic significance of pleural or pericardial effusion and the implication of optimal treatment in primary mediastinal large B-cell lymphoma: a multicenter retrospective study in Japan. Haematologica. 2014 Dec;99(12):1817-25. doi: 10.3324/haematol.2014.111203. Epub 2014 Sep 12.'}]}, 'descriptionModule': {'briefSummary': 'This is a retrospective, multicenter study focused on patients with a known diagnosis of PMLBCL which experienced a CNS relapse during the course of their disease to obtain information about the clinical characteristics, the management at diagnosis and at each relapses , and the outcome of these cases. The aim of the study is to put together the large International series on CNS+ PMLBCL data, coming from 6 different countries , on clinical factors, anti-lymphoma therapy administered alone or concomitant with CNS prophylaxis , the information about the site of re biopsy when available , the dose intensity of lymphoma therapy received at relapse and the outcome of patients.\n\nBoth patients treated in routine practice or within clinical trials will be considered. Moreover to better characterized the pathological features of this rare entity a central pathological review of the initial diagnosis and when available of for histological confirmed relapse will be considered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients whose diagnosis met the histological criteria of PMLBL according WHO classification with a diagnosis of CNS involvement at relapse/progression.\n\nPatients eligible to the study will be retrospectively identified by the site researches by interrogating the local site sources.\n\nAvailability of local pathological report at time of diagnosis and restaging will be considered for eligibility.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed diagnosis of Primary Mediastinal Large B Cell Lymphoma (PMLBCL) according WHO Classification\n* Had a recurrence/progression with Central Nervous System (CNS) involvement\n* Availability of details on clinical presentation, treatment details and outcome\n* Availability of details on pathological data for central review\n* Age ≥18 years\n\nExclusion Criteria\n\n* Patients with CNS lymphoma other than PMLBCL subtype'}, 'identificationModule': {'nctId': 'NCT06024694', 'briefTitle': 'Primary Mediastinal Large B-cell Lymphoma With CNS Involvement', 'nctIdAliases': ['NCT05856708'], 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Retrospective Multicenter International Study on Prognostic Factors, Management And Outcome Of Primary Mediastinal Large B-Cell Lymphoma (PMLBCL) Patients With Central Nervous System (CNS) Involvement', 'orgStudyIdInfo': {'id': 'OSR PMLBCL SNC+'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients diagnosed with PMLBL', 'description': 'Patients whose diagnosis met the histological criteria of PMLBL according WHO classification with a diagnosis of CNS involvement at relapse/progression'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'Italy', 'country': 'Italy', 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lymphoma Unit Director', 'investigatorFullName': 'Andrés José Maria Ferreri', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}