Clinical trial NCT06781359: Study on Plasmablastic Lymphoma Patients
Official title: An International Multicenter Observational Retrospective Study on Plasmablastic Lymphoma Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Plasmablastic Lymphoma
Keywords: Plasmablastic lymphoma
PBL
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
Collaborators: name: AIL Roma - Italia
name: AIL Cuneo - Italia
First posted: 2025-01-17
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients (Age ≥ 18 years old) with diagnosis of plasmablastic lymphoma (Histologically confirmed) between Jan 1st 2000, and Dec 31st 2022

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of plasmablastic lymphoma (PBL) between Jan 1st 2000, and Dec 31st 2022
* Histologically confirmed plasmablastic lymphoma (PBL) diagnosis according to local pathological report
* Age \> 18 years old
* Availability of complete medical records
* Availability of histopathological material requested by the study

Exclusion Criteria:

* Any other histology than PBL
* Lack of complete medical records
* Lack of histopathological material requested by the study

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 36 months
Secondary outcomes:
measure: ECOG-PS
timeFrame: 36 months
measure: Ann Arbor Stage
timeFrame: 36 months
measure: Kidney and/or adrenal gland involvement
timeFrame: 36 months
measure: Diagnostic liquor
timeFrame: 36 months
measure: Splenic involvement
timeFrame: 36 months
measure: Type of chemotherapy (CHT) regimen
timeFrame: 36 months
measure: Complete remission rate (CR)
timeFrame: 36 months
measure: Overall response rate (ORR)
timeFrame: 36 monts
measure: Progression-free survival (PFS)
timeFrame: 36 months
measure: Validation of IPI and CNS-IPI score by means of Cox PH regression on OS and PFS
timeFrame: 36 months
measure: Frequencies of HIV and EBV at relapse
timeFrame: 36 months
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: IRCCS Centro di Riferimento Oncologico di Aviano, Divisione di Oncologia e dei Tumori immuno-correlati
state: PN
city: Ascoli Piceno
country: Italy
facility: Ospedale C.e G. Mazzoni, U.O.C. di Ematologia
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia, Ematologia
city: Cuneo
country: Italy
facility: A.O. S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi, Unità funzionale di Ematologia
city: Milano
country: Italy
facility: ASST -Fatebenefratelli - Polo Luigi Sacco Oncologia
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia
city: Milano
country: Italy
facility: Istituto Scientifico San Raffaele, Unità Linfomi - Dipartimento Oncoematologia
city: Milano
country: Italy
facility: Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda, Ematologia
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori, Ematologia
city: Novara
country: Italy
facility: AOU Maggiore della Caritа di Novara, SCDU Ematologia
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova, Ematologia
city: Pagani
country: Italy
facility: Presidio ospedaliero A. Tortora, U.O. Onco-ematologia
city: Reggio Emilia
country: Italy
facility: Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova, Ematologia
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Sant' Andrea, Ematologia
city: Roma
country: Italy
facility: Policlinico Umberto I - Università La Sapienza, Istituto Ematologia, Dipartimento di Medicina Traslazionale e di Precisione
city: Roma
country: Italy
facility: Universitа Cattolica S. Cuore, Ematologia
city: Siena
country: Italy
facility: Azienda Ospedaliero Universitaria Senese, U.O.C. Ematologia
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino, Ematologia Universitaria
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino, S.C. Ematologia
city: Trento
country: Italy
facility: Ospedale S. Chiara, S.S. di Ematologia
city: Treviso
country: Italy
facility: ULSS2 Marca Trevigiana, Ospedale Ca' Foncello, S.C di Ematologia
city: Vicenza
country: Italy
facility: ULSS 8 Berica - Ospedale S. Bortolo, Ematologia
Study officials:
affiliation: UO Ematologia, AO Santa Croce e Carle, Cuneo - Italy
name: Alessia Castellino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UO Ematologia, Niguarda Grande Ospedale Metropolitano, Milano - Italy.
name: Emanuele Ravano, MD
role: PRINCIPAL_INVESTIGATOR
References: