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NCT Number: NCT06781359

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.

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Key information

Conditions

Plasmablastic Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. ECOG-PS

    Time frame: 36 months

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

  2. Ann Arbor Stage

    Time frame: 36 months

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

  3. Kidney and/or adrenal gland involvement

    Time frame: 36 months

    Proportion of the presence of involvement

  4. Diagnostic liquor

    Time frame: 36 months

    Proportion of the presence of liquor

  5. Splenic involvement

    Time frame: 36 months

    Proportion of spenic involvement

  6. Type of chemotherapy (CHT) regimen

    Time frame: 36 months

    Proportion of CHT administered

  7. Complete remission rate (CR)

    Time frame: 36 months

    CR at the end of treatment

  8. 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

  9. 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,

  10. 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).

  11. Frequencies of HIV and EBV at relapse

    Time frame: 36 months

    Frequencies of HIV and EBV at relapse

Study contacts

Contact information is provided by the study sponsor or research team.

Uffici Studi FIL

CONTACT

[email protected]

+390131033153

Uffici Studi FIL

CONTACT

[email protected]

+390131033160

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Linfomi - ETS

Other

Collaborators

  • AIL Cuneo - Italia
  • AIL Roma - Italia

Registry information

Official study title

An International Multicenter Observational Retrospective Study on Plasmablastic Lymphoma Patients

Acronym: FIL_PlaLy

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 17, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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