Study on Plasmablastic Lymphoma Patients

An International Multicenter Observational Retrospective Study on Plasmablastic Lymphoma Patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06781359

Acronym

FIL_PlaLy

Enrollment

200

Registered

2025-01-17

Start date

2025-02-14

Completion date

2028-02-01

Last updated

2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plasmablastic Lymphoma

Keywords

Plasmablastic lymphoma, PBL

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Overall Survival (OS)	36 months	OS is defined as the time from the diagnosis to death for any cause or last clinical contact for censored patients.

Secondary

Measure	Time frame	Description
Overall response rate (ORR)	36 monts	ORR is defined as the proportion of patients who have a partial or complete response to therapy
Progression-free survival (PFS)	36 months	PFS is defined as time from diagnosis to progression, relapse or death for any cause and last clinical contact for censored cases,
Validation of IPI and CNS-IPI score by means of Cox PH regression on OS and PFS	36 months	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).
Frequencies of HIV and EBV at relapse	36 months	Frequencies of HIV and EBV at relapse
ECOG-PS	36 months	Proportion of Performance Status: from 0 (fully active) to 4 (Completely disabled)
Ann Arbor Stage	36 months	Proportion of stage: from I (better) to IV (worse)
Kidney and/or adrenal gland involvement	36 months	Proportion of the presence of involvement
Diagnostic liquor	36 months	Proportion of the presence of liquor
Splenic involvement	36 months	Proportion of spenic involvement
Complete remission rate (CR)	36 months	CR at the end of treatment
Type of chemotherapy (CHT) regimen	36 months	Proportion of CHT administered

Countries

Italy

Contacts

CONTACTUffici Studi FIL

startup@filinf.it+390131033153

PRINCIPAL_INVESTIGATORAlessia Castellino, MD

UO Ematologia, AO Santa Croce e Carle, Cuneo - Italy

PRINCIPAL_INVESTIGATOREmanuele Ravano, MD

UO Ematologia, Niguarda Grande Ospedale Metropolitano, Milano - Italy.

Outcome results