PTLD: Multicentric Retrospective Study (FIL_PTLD)

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

Post-transplant Lymphoproliferative Disorders (PTLD): Multicentric Observational Retrospective Cohort Study

This is a multicentric observational retrospective cohort study of patients with histological diagnosis of PTLD.

The aim of the study is to analyze the clinical features and survival of patients who received a PTLD diagnosis with the target to assess a survival outcome, to obtain an epidemiologic and clinical characterization of the subpopulations affected by PTLD, to recognize unfavorable properties, to report the current treatment strategies, to provide rationale for the design of a prospective registry in order to develop future novel treatments.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

This is a multicentric observational retrospective cohort study of patients with histological diagnosis of PTLD. Retrospective data will be collected for all cases of PTLD diagnosed during a 10 years period since 1st January 2011 to 31th December 2021.

The following clinical characteristics of the patient at the time of PTLD diagnosis and pathology will be taken into consideration: positivity of EBV virus, serum LDH concentration, PTLD subtype (early lesion, polymorphic or monomorphic PTLD), lymphoma histotype, stage of disease according to the Ann Arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted, and response obtained.

Study Type

Observational

Enrollment (Actual)

241

Contacts and Locations

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

Study Locations

  • Italy
      • Aviano, Italy
        • Centro Di Riferimento Oncologico Di Aviano, S.O.C. Oncologia Medica e dei Tumori Immunocorrelati
      • Bergamo, Italy, 24127
        • Azienda Ospedaliera Papa Giovanni XXIII - Ematologia
      • Bologna, Italy, 40138
        • A.O. UNIVERSITARIA POLICLINICO S.ORSOLA-MALPIGHI DI BOLOGNA - Istituto di Ematologia "Seragnoli"
      • Brescia, Italy
        • A.O. Spedali Civili di Brescia - Ematologia
      • Cagliari, Italy
        • Ospedale Businco - Divisione di Ematologia
      • Cuneo, Italy
        • A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo
      • Florence, Italy, 50139
        • A.O. UNIVERSITARIA CAREGGI DI FIRENZE - Unità funzionale di Ematologia
      • Miano, Italy
        • ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
      • Milan, Italy, 20132
        • Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia
      • Novara, Italy
        • AOU Maggiore della Caritа di Novara - SCDU Ematologia
      • Padua, Italy, 35128
        • IRCCS ISTITUTO ONCOLOGICO VENETO (IOV) - Oncologia 1
      • Pavia, Italy
        • IRCCS Policlinico San Matteo - Divisione di Ematologia
      • Roma, Italy
        • Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia
      • Roma, Italy, 00128
        • Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
      • Roma, Italy, 00161
        • Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università "La Sapienza" Istituto Ematologia
      • Siena, Italy, 53100
        • AOU Senese - U.O.C. Ematologia
      • Torino, Italy, 10126
        • A.O. UNIVERSITARIA CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - SC Ematologia
      • Torino, Italy
        • A.O. Città della Salute e della Scienza - Ematologia Universitaria
      • Udine, Italy, 33100
        • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica
      • Vicenza, Italy, 36100
        • ULSS 8 Berica - Ospedale S. Bortolo - Ematologia
    • MI
      • Milan, MI, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Ematologia

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Population will be composed by patients with histological diagnosis of PTLD. The following clinical characteristics of the patient at the diagnosis of PTLD and pathology will be taken into consideration: positivity of EBV virus, serum LDH concentration, PTLD subtype (early lesion, polymorphic or monomorphic PTLD), lymphoma histotype, stage of disease according to the Ann Arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted and response obtained.

Description

Inclusion Criteria:

  • histological diagnosis of PTLD obtained from a biopsy sample (availability of stocked biopsy sample is requested but not mandatory);
  • age over 18 years at time of diagnosis of PTLD;
  • previously subjected to allogeneic transplantation (both SOT and HSCT);
  • diagnosis of PTLD obtained in 10 years' time frame (from 01/01/2011 to 31/12/2021);
  • free and voluntary written informed consent (included unreachable subjects according to Art. 36 UE Regulation 2016/679 and to the current Italian Privacy Regulation).

Exclusion Criteria:

  • Patients not meeting the above-mentioned inclusion criteria.

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
patients with histological diagnosis of PTLD
patients with histological diagnosis obtained from a biopsy sample in 10 years' time frame (from 01/01/2011 to 31/12/2021) of PTLD (from allogeneic transplantation (both SOT and HSCT))

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Overall Survival
Time Frame: from diagnosis of PTLD to patient's death / last FUP - up to 18 months.
survival after PTLD incidence rating
from diagnosis of PTLD to patient's death / last FUP - up to 18 months.
clinical and epidemiological features
Time Frame: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
analyze the clinical and epidemiological features (e.g. positivity of EBV virus, serum LDH concentration, PTLD subtype (early lesion, polymorphic or monomorphic PTLD), lymphoma histotype, stage of disease according to the Ann Arbor classification and localization (nodal or extranodal), immunosuppressive regimen taken by the patient since the transplant, therapeutic approach adopted and response obtained) of PTLD patients
from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Progression Free Survival
Time Frame: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
compare outcomes according to treatment approaches
from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Overall Response Rate
Time Frame: from treatment of PTLD to patient's death / last FUP - up to 18 months.
investigate potential treatment effect modifications on outcomes according to patient characteristics
from treatment of PTLD to patient's death / last FUP - up to 18 months.
Complete Response Rate to first and subsequent treatments
Time Frame: from treatment of PTLD to patient's death / last FUP - up to 18 months.
investigate potential treatment effect modifications on outcomes according to patient
from treatment of PTLD to patient's death / last FUP - up to 18 months.
Overall Survival stratified by prognostic factors
Time Frame: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Overall Survival assessment stratified by prognostic factors (EBV, LDH, IPI, age, type of transplant)
from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Progression Free Survival stratified by prognostic factors
Time Frame: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Progression Free Survival assessment stratified by prognostic factors (EBV, LDH, IPI, age, type of transplant)
from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.

Collaborators and Investigators

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

Sponsor

Fondazione Italiana Linfomi - ETS

Collaborators

Pierre Fabre Pharma AG

Investigators

  • Principal Investigator: Federica Cavallo, MD, Ematologia Universitaria - A.O.U. Citta della Salute e della Scienza di Torino

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)

October 30, 2024

Primary Completion (Actual)

August 12, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 21, 2024

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_PTLD

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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