Study on Plasmablastic Lymphoma Patients

Not yet recruiting

• Conditions: Plasmablastic Lymphoma

• Registration Number: NCT06781359
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

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.

Study Timeline

• Study First Submitted: 2024-12-05
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Study Start: 2025-02-01
• Primary Completion: 2028-02-01
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Complete remission rate (CR)	36 months	CR at the end of treatment
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
Type of chemotherapy (CHT) regimen	36 months	Proportion of CHT administered
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

Trial Locations

Locations (23)

IRCCS Centro di Riferimento Oncologico di Aviano, Divisione di Oncologia e dei Tumori immuno-correlati; 🇮🇹 Aviano, PN, Italy

Azienda Ospedaliera Universitaria Careggi, Unità funzionale di Ematologia; 🇮🇹 Firenze, Italy

ASST -Fatebenefratelli - Polo Luigi Sacco Oncologia; 🇮🇹 Milano, Italy

AOU Maggiore della Caritа di Novara, SCDU Ematologia; 🇮🇹 Novara, Italy

Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova, Ematologia; 🇮🇹 Reggio Emilia, Italy

Policlinico Umberto I - Università La Sapienza, Istituto Ematologia, Dipartimento di Medicina Traslazionale e di Precisione; 🇮🇹 Roma, Italy

Azienda Ospedaliero Universitaria Senese, U.O.C. Ematologia; 🇮🇹 Siena, Italy

A.O.U. Città della Salute e della Scienza di Torino, Ematologia Universitaria; 🇮🇹 Torino, Italy

Ospedale S. Chiara, S.S. di Ematologia; 🇮🇹 Trento, Italy

Ospedale C.e G. Mazzoni, U.O.C. di Ematologia; 🇮🇹 Ascoli Piceno, Italy

ASST Spedali Civili di Brescia, Ematologia; 🇮🇹 Brescia, Italy

ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia; 🇮🇹 Milano, Italy

Istituto Scientifico San Raffaele, Unità Linfomi - Dipartimento Oncoematologia; 🇮🇹 Milano, Italy

Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda, Ematologia; 🇮🇹 Milano, Italy

Fondazione IRCCS San Gerardo dei Tintori, Ematologia; 🇮🇹 Monza, Italy

Azienda Ospedaliera Universitaria Sant' Andrea, Ematologia; 🇮🇹 Roma, Italy

A.O. S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo; 🇮🇹 Cuneo, Italy

Azienda Ospedaliera Universitaria di Padova, Ematologia; 🇮🇹 Padova, Italy

Presidio ospedaliero A. Tortora, U.O. Onco-ematologia; 🇮🇹 Pagani, Italy

Universitа Cattolica S. Cuore, Ematologia; 🇮🇹 Roma, Italy

A.O.U. Città della Salute e della Scienza di Torino, S.C. Ematologia; 🇮🇹 Torino, Italy

ULSS2 Marca Trevigiana, Ospedale Ca' Foncello, S.C di Ematologia; 🇮🇹 Treviso, Italy

ULSS 8 Berica - Ospedale S. Bortolo, Ematologia; 🇮🇹 Vicenza, Italy