Study on Plasmablastic Lymphoma Patients
FIL_PlaLy
An International Multicenter Observational Retrospective Study on Plasmablastic Lymphoma Patients
1 other identifier
observational
200
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Typical duration for all trials
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2024
CompletedFirst Posted
Study publicly available on registry
January 17, 2025
CompletedStudy Start
First participant enrolled
February 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
December 2, 2025
December 1, 2025
3 years
December 5, 2024
December 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
36 months
Secondary Outcomes (11)
ECOG-PS
36 months
Ann Arbor Stage
36 months
Kidney and/or adrenal gland involvement
36 months
Diagnostic liquor
36 months
Splenic involvement
36 months
- +6 more secondary outcomes
Study Arms (1)
Plasmablastic lymphoma patients
Patients with diagnosis (histologically confirmed) of plasmablastic lymphoma (PBL) between Jan 1st 2000 and Dec 31st 2022
Eligibility Criteria
Patients (Age ≥ 18 years old) with diagnosis of plasmablastic lymphoma (Histologically confirmed) between Jan 1st 2000, and Dec 31st 2022
You may qualify if:
- 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
You may not qualify if:
- Any other histology than PBL
- Lack of complete medical records
- Lack of histopathological material requested by the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondazione Italiana Linfomi - ETSlead
- AIL Roma - Italiacollaborator
- AIL Cuneo - Italiacollaborator
Study Sites (23)
IRCCS Centro di Riferimento Oncologico di Aviano, Divisione di Oncologia e dei Tumori immuno-correlati
Aviano, PN, Italy
Ospedale C.e G. Mazzoni, U.O.C. di Ematologia
Ascoli Piceno, Italy
ASST Spedali Civili di Brescia, Ematologia
Brescia, Italy
A.O. S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo
Cuneo, Italy
Azienda Ospedaliera Universitaria Careggi, Unità funzionale di Ematologia
Florence, Italy
ASST -Fatebenefratelli - Polo Luigi Sacco Oncologia
Milan, Italy
ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia
Milan, Italy
Istituto Scientifico San Raffaele, Unità Linfomi - Dipartimento Oncoematologia
Milan, Italy
Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda, Ematologia
Milan, Italy
Fondazione IRCCS San Gerardo dei Tintori, Ematologia
Monza, Italy
AOU Maggiore della Caritа di Novara, SCDU Ematologia
Novara, Italy
Azienda Ospedaliera Universitaria di Padova, Ematologia
Padua, Italy
Presidio ospedaliero A. Tortora, U.O. Onco-ematologia
Pagani, Italy
Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova, Ematologia
Reggio Emilia, Italy
Azienda Ospedaliera Universitaria Sant' Andrea, Ematologia
Roma, Italy
Policlinico Umberto I - Università La Sapienza, Istituto Ematologia, Dipartimento di Medicina Traslazionale e di Precisione
Roma, Italy
Universitа Cattolica S. Cuore, Ematologia
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
A.O.U. Città della Salute e della Scienza di Torino, S.C. Ematologia
Torino, Italy
Ospedale S. Chiara, S.S. di Ematologia
Trento, Italy
ULSS2 Marca Trevigiana, Ospedale Ca' Foncello, S.C di Ematologia
Treviso, Italy
ULSS 8 Berica - Ospedale S. Bortolo, Ematologia
Vicenza, Italy
Biospecimen
Histological and immunohistochemical slides used for the original diagnosis + block
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2024
First Posted
January 17, 2025
Study Start
February 14, 2025
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2028
Last Updated
December 2, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- 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.
- 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.
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).