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Plasmablastic LymphomaFIL_PlaLyNCT06781359

Study on Plasmablastic Lymphoma Patients

An observational study of Plasmablastic Lymphoma, run by Fondazione Italiana Linfomi - ETS at 23 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Plasmablastic Lymphoma
How many people
200 participants
Where
23 sitesItaly
Study dates
14 Feb 2025to 1 Feb 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients (Age ≥ 18 years old) with diagnosis of plasmablastic lymphoma (Histologically confirmed) between Jan 1st 2000, and Dec 31st 2022

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

23 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Uffici Studi FIL contact

+390131033153

startup@filinf.it

Uffici Studi FIL contact

+390131033160

gestionestudi@filinf.it

23 sites in 1 country

Italy23 sites, 18 recruiting

  • Ospedale C.e G. Mazzoni, U.O.C. di Ematologia

    Ascoli Piceno

    Piero Galieni, MD, piero.galieni@sanita.marche.it

    Piero Galieni, MD

    Recruiting

  • IRCCS Centro di Riferimento Oncologico di Aviano, Divisione di Oncologia e dei Tumori immuno-correlati

    Aviano, PN

    Michele Spina, MD, mspina@cro.it

    Michele Spina, MD

    Recruiting

  • ASST Spedali Civili di Brescia, Ematologia

    Brescia

    Active, not recruiting

  • A.O. S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo

    Cuneo

    Claudia Castellino, MD, castellino.c@ospedale.cuneo.it

    Claudia Castellino, MD

    Recruiting

  • Azienda Ospedaliera Universitaria Careggi, Unità funzionale di Ematologia

    Florence

    Luca Nassi, MD, nassil@aou-careggi.toscana.it

    Luca Nassi, MD

    Recruiting

  • ASST -Fatebenefratelli - Polo Luigi Sacco Oncologia

    Milan

    Nicla La Verde, MD, nicla.laverde@asst-fbf-sacco.it

    Nicla La Verde, MD

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia

    Milan

    Emanuele Ravano, MD, emanuele.ravano@ospedaleniguarda.it

    Emanuele Ravano, MD

    Recruiting

  • Istituto Scientifico San Raffaele, Unità Linfomi - Dipartimento Oncoematologia

    Milan

    Active, not recruiting

  • Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda, Ematologia

    Milan

    Active, not recruiting

  • Fondazione IRCCS San Gerardo dei Tintori, Ematologia

    Monza

    Luisa Verga, MD, luisa.verga@irccs-sangerardo.it

    Luisa Verga, MD

    Recruiting

  • AOU Maggiore della Caritа di Novara, SCDU Ematologia

    Novara

    Active, not recruiting

  • Azienda Ospedaliera Universitaria di Padova, Ematologia

    Padova

    Greta Scapinello, MD, greta.scapinello@aopd.veneto.it

    Greta Scapinello, MD

    Not yet recruiting

  • Presidio ospedaliero A. Tortora, U.O. Onco-ematologia

    Pagani

    Catello Califano, MD, c.califano@aslsalerno.it

    Catello Califano, MD

    Not yet recruiting

  • Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova, Ematologia

    Reggio Emilia

    Angela Ferrari, MD, ferrari.angela@ausl.re.it

    Angela Ferrari, MD

    Recruiting

  • Azienda Ospedaliera Universitaria Sant' Andrea, Ematologia

    Roma

    Agostino Tafuri, Prof, agostino.tafuri@ospedalesantandrea.it

    Agostino Tafuri, Prof

    Recruiting

  • Policlinico Umberto I - Università La Sapienza, Istituto Ematologia, Dipartimento di Medicina Traslazionale e di Precisione

    Roma

    Alice Di Rocco, MD, dirocco@bce.uniroma1.it

    Alice Di Rocco, MD

    Recruiting

  • Universitа Cattolica S. Cuore, Ematologia

    Roma

    Stefan Hohaus, Prof, stefan.hohaus@Unicatt.it

    Stefan Hohaus, Prof

    Not yet recruiting

  • Azienda Ospedaliero Universitaria Senese, U.O.C. Ematologia

    Siena

    Emanuele Cencini, MD, cencioema@libero.it

    Emanuele Cencini, MD

    Recruiting

  • A.O.U. Città della Salute e della Scienza di Torino, Ematologia Universitaria

    Torino

    Federica Cavallo, MD, f.cavallo@unito.it

    Federica Cavallo, MD

    Not yet recruiting

  • A.O.U. Città della Salute e della Scienza di Torino, S.C. Ematologia

    Torino

    Barbara Botto, MD, bbotto@cittadellasalute.to.it

    Barbara Botto, MD

    Recruiting

  • Ospedale S. Chiara, S.S. di Ematologia

    Trento

    Chandrakala Toldo, MD, chandrakala.toldo@apss.tn.it

    Chandrakala Toldo, MD

    Recruiting

  • ULSS2 Marca Trevigiana, Ospedale Ca' Foncello, S.C di Ematologia

    Treviso

    Active, not recruiting

  • ULSS 8 Berica - Ospedale S. Bortolo, Ematologia

    Vicenza

    Marcello Riva, MD, riva.marcello83@gmail.com

    Marcello Riva, MD

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Keywords
Plasmablastic lymphoma, PBL
Medical subject headings
Plasmablastic Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06781359
Study groupRoleWhat they receive
Plasmablastic lymphoma patientsPatients with diagnosis (histologically confirmed) of plasmablastic lymphoma (PBL) between Jan 1st 2000 and Dec 31st 2022

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS is defined as the time from the diagnosis to death for any cause or last clinical contact for censored patients.

    Measured: 36 months

Secondary outcomes (11)

  1. ECOG-PS

    Proportion of Performance Status: from 0 (fully active) to 4 (Completely disabled)

    Measured: 36 months

  2. Ann Arbor Stage

    Proportion of stage: from I (better) to IV (worse)

    Measured: 36 months

  3. Kidney and/or adrenal gland involvement

    Proportion of the presence of involvement

    Measured: 36 months

  4. Diagnostic liquor

    Proportion of the presence of liquor

    Measured: 36 months

  5. Splenic involvement

    Proportion of spenic involvement

    Measured: 36 months

  6. Type of chemotherapy (CHT) regimen

    Proportion of CHT administered

    Measured: 36 months

  7. Complete remission rate (CR)

    CR at the end of treatment

    Measured: 36 months

  8. Overall response rate (ORR)

    ORR is defined as the proportion of patients who have a partial or complete response to therapy

    Measured: 36 monts

  9. 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,

    Measured: 36 months

  10. 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).

    Measured: 36 months

  11. Frequencies of HIV and EBV at relapse

    Frequencies of HIV and EBV at relapse

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2025
  2. Study start14 Feb 2025
  3. Primary completion1 Feb 2028 (estimated)
  4. Study completion1 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06781359
Sponsor's protocol ID
FIL_PlaLy
Acronym
FIL_PlaLy
Status last verified
Aug 2026
First submitted
5 Dec 2024
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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).

Questions about this trial

What is this clinical trial studying?

An observational study of Plasmablastic Lymphoma, run by Fondazione Italiana Linfomi - ETS at 23 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Uffici Studi FIL (+390131033153, startup@filinf.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06781359.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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