An observational study in Plasmablastic Lymphoma, sponsored by Fondazione Italiana Linfomi - ETS. Recruiting at 23 sites in Italy. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Fondazione Italiana Linfomi - ETS · Observational
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.
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.
Patients (Age ≥ 18 years old) with diagnosis of plasmablastic lymphoma (Histologically confirmed) between Jan 1st 2000, and Dec 31st 2022
Exclusion Criteria:
Patients with diagnosis (histologically confirmed) of plasmablastic lymphoma (PBL) between Jan 1st 2000 and Dec 31st 2022
Overall Survival (OS)
OS is defined as the time from the diagnosis to death for any cause or last clinical contact for censored patients.
Time frame: 36 months
ECOG-PS
Proportion of Performance Status: from 0 (fully active) to 4 (Completely disabled)
Time frame: 36 months
Ann Arbor Stage
Proportion of stage: from I (better) to IV (worse)
Time frame: 36 months
Kidney and/or adrenal gland involvement
Proportion of the presence of involvement
Time frame: 36 months
Diagnostic liquor
Proportion of the presence of liquor
Time frame: 36 months
Splenic involvement
Proportion of spenic involvement
Time frame: 36 months
Type of chemotherapy (CHT) regimen
Proportion of CHT administered
Time frame: 36 months
Complete remission rate (CR)
CR at the end of treatment
Time frame: 36 months
Overall response rate (ORR)
ORR is defined as the proportion of patients who have a partial or complete response to therapy
Time frame: 36 monts
Progression-free survival (PFS)
PFS is defined as time from diagnosis to progression, relapse or death for any cause and last clinical contact for censored cases,
Time frame: 36 months
Validation of IPI and CNS-IPI score by means of Cox PH regression on OS and PFS
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).
Time frame: 36 months
Frequencies of HIV and EBV at relapse
Frequencies of HIV and EBV at relapse
Time frame: 36 months
Plan to share: Yes — 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).
Supporting information: Study protocol, Sap, Analytic code
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Fondazione Italiana Linfomi - ETS