Study on Plasmablastic Lymphoma Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Plasmablastic Lymphoma. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An International Multicenter Observational Retrospective Study on Plasmablastic Lymphoma Patients
Overview
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.
Primary outcome measures
- Overall Survival (OS) [Time frame: 36 months]
Secondary outcome measures (11)
- ECOG-PS [Time frame: 36 months]
- Ann Arbor Stage [Time frame: 36 months]
- Kidney and/or adrenal gland involvement [Time frame: 36 months]
- Diagnostic liquor [Time frame: 36 months]
- Splenic involvement [Time frame: 36 months]
- Type of chemotherapy (CHT) regimen [Time frame: 36 months]
- Complete remission rate (CR) [Time frame: 36 months]
- Overall response rate (ORR) [Time frame: 36 monts]
- Progression-free survival (PFS) [Time frame: 36 months]
- Validation of IPI and CNS-IPI score by means of Cox PH regression on OS and PFS [Time frame: 36 months]
- Frequencies of HIV and EBV at relapse [Time frame: 36 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 23 centers
- IRCCS Centro di Riferimento Oncologico di Aviano, Divisione di Oncologia e dei Tumori immu — Aviano
- Ospedale C.e G. Mazzoni, U.O.C. di Ematologia — Ascoli Piceno
- ASST Spedali Civili di Brescia, Ematologia — Brescia
- A.O. S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo — Cuneo
- Azienda Ospedaliera Universitaria Careggi, Unità funzionale di Ematologia — Florence
- ASST -Fatebenefratelli - Polo Luigi Sacco Oncologia — Milan
- ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia — Milan
- Istituto Scientifico San Raffaele, Unità Linfomi - Dipartimento Oncoematologia — Milan
- … and 15 more centers
Identifiers
NCT: NCT06781359 · FIL_PlaLy