Study on Plasmablastic Lymphoma Patients (FIL_PlaLy)

December 1, 2025 updated by: Fondazione Italiana Linfomi - ETS

An International Multicenter Observational Retrospective Study on Plasmablastic Lymphoma Patients

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Ascoli Piceno, Italy
        • Recruiting
        • Ospedale C.e G. Mazzoni, U.O.C. di Ematologia
        • Contact:
        • Principal Investigator:
          • Piero Galieni, MD
      • Brescia, Italy
        • Not yet recruiting
        • ASST Spedali Civili di Brescia, Ematologia
        • Contact:
        • Principal Investigator:
          • Alessandro Re, MD
      • Cuneo, Italy
        • Recruiting
        • A.O. S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo
        • Contact:
        • Principal Investigator:
          • Claudia Castellino, MD
      • Florence, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi, Unità funzionale di Ematologia
        • Principal Investigator:
          • Luca Nassi, MD
        • Contact:
      • Milan, Italy
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia
        • Principal Investigator:
          • Emanuele Ravano, MD
        • Contact:
      • Milan, Italy
        • Not yet recruiting
        • ASST -Fatebenefratelli - Polo Luigi Sacco Oncologia
        • Principal Investigator:
          • Nicla La Verde, MD
        • Contact:
      • Milan, Italy
        • Recruiting
        • Istituto Scientifico San Raffaele, Unità Linfomi - Dipartimento Oncoematologia
        • Contact:
        • Principal Investigator:
          • Andrés JM Ferreri, Prof
      • Milan, Italy
        • Not yet recruiting
        • Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda, Ematologia
        • Contact:
        • Principal Investigator:
          • Francesca Gaia Rossi, MD
      • Monza, Italy
        • Recruiting
        • Fondazione IRCCS San Gerardo dei Tintori, Ematologia
        • Principal Investigator:
          • Luisa Verga, MD
        • Contact:
      • Novara, Italy
        • Recruiting
        • AOU Maggiore della Caritа di Novara, SCDU Ematologia
        • Principal Investigator:
          • Riccardo Bruna, MD
        • Contact:
      • Padua, Italy
        • Not yet recruiting
        • Azienda Ospedaliera Universitaria di Padova, Ematologia
        • Principal Investigator:
          • Greta Scapinello, MD
        • Contact:
      • Pagani, Italy
        • Not yet recruiting
        • Presidio ospedaliero A. Tortora, U.O. Onco-ematologia
        • Contact:
        • Principal Investigator:
          • Catello Califano, MD
      • Reggio Emilia, Italy
        • Recruiting
        • Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova, Ematologia
        • Contact:
        • Principal Investigator:
          • Angela Ferrari, MD
      • Roma, Italy
        • Recruiting
        • Policlinico Umberto I - Università La Sapienza, Istituto Ematologia, Dipartimento di Medicina Traslazionale e di Precisione
        • Contact:
        • Principal Investigator:
          • Alice Di Rocco, MD
      • Roma, Italy
        • Not yet recruiting
        • Universitа Cattolica S. Cuore, Ematologia
        • Contact:
        • Principal Investigator:
          • Stefan Hohaus, Prof
      • Roma, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Sant' Andrea, Ematologia
        • Contact:
        • Principal Investigator:
          • Agostino Tafuri, Prof
      • Siena, Italy
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria Senese, U.O.C. Ematologia
        • Contact:
        • Principal Investigator:
          • Emanuele Cencini, MD
      • Torino, Italy
        • Not yet recruiting
        • A.O.U. Città della Salute e della Scienza di Torino, Ematologia Universitaria
        • Contact:
        • Principal Investigator:
          • Federica Cavallo, MD
      • Torino, Italy
        • Not yet recruiting
        • A.O.U. Città della Salute e della Scienza di Torino, S.C. Ematologia
        • Principal Investigator:
          • Barbara Botto, MD
        • Contact:
      • Trento, Italy
        • Recruiting
        • Ospedale S. Chiara, S.S. di Ematologia
        • Principal Investigator:
          • Chandrakala Toldo, MD
        • Contact:
      • Treviso, Italy
        • Not yet recruiting
        • ULSS2 Marca Trevigiana, Ospedale Ca' Foncello, S.C di Ematologia
        • Contact:
        • Principal Investigator:
          • Piero Maria Stefani, MD
      • Vicenza, Italy
        • Recruiting
        • ULSS 8 Berica - Ospedale S. Bortolo, Ematologia
        • Contact:
        • Principal Investigator:
          • Marcello Riva, MD
    • PN
      • Aviano, PN, Italy
        • Recruiting
        • IRCCS Centro di Riferimento Oncologico di Aviano, Divisione di Oncologia e dei Tumori immuno-correlati
        • Contact:
        • Principal Investigator:
          • Michele Spina, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Plasmablastic lymphoma patients
Patients with diagnosis (histologically confirmed) of plasmablastic lymphoma (PBL) between Jan 1st 2000 and Dec 31st 2022

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi - ETS

Collaborators

AIL Roma - Italia
AIL Cuneo - Italia

Investigators

  • Principal Investigator: Alessia Castellino, MD, UO Ematologia, AO Santa Croce e Carle, Cuneo - Italy
  • Principal Investigator: Emanuele Ravano, MD, UO Ematologia, Niguarda Grande Ospedale Metropolitano, Milano - Italy.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2025

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

January 17, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_PlaLy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

IPD Sharing Time Frame

In compliance with the domestic ethics guideline and applicable legislation, invidual deindentified patients' data underlying the results reported in teh publication article (including study protocol, statistical analysis plan and data coding) can be shared until 5 years after the publication of the present article.

IPD Sharing Access Criteria

For each data sharing request, it is essential that a proforma (available on request) is completed that describes the general purpose, specific aims, data items requested, analysis plan and acknowledgment of the trial management team. Requests will be reviewed based on scientific merit and ethical principles. Requestors who are granted access to the data will be required to complete a data sharing agreement that will be signed by the requester and FIL.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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