PTLD: Multicentric Retrospective Study

NCT ID: NCT06422715

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

241 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-30

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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PTLD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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))

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pierre Fabre Pharma AG

INDUSTRY

Sponsor Role collaborator

Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Federica Cavallo, MD

Role: PRINCIPAL_INVESTIGATOR

Ematologia Universitaria - A.O.U. Citta della Salute e della Scienza di Torino

Locations

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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Ematologia

Milan, MI, Italy

Site Status

Centro Di Riferimento Oncologico Di Aviano, S.O.C. Oncologia Medica e dei Tumori Immunocorrelati

Aviano, , Italy

Site Status

Azienda Ospedaliera Papa Giovanni XXIII - Ematologia

Bergamo, , Italy

Site Status

A.O. UNIVERSITARIA POLICLINICO S.ORSOLA-MALPIGHI DI BOLOGNA - Istituto di Ematologia "Seragnoli"

Bologna, , Italy

Site Status

A.O. Spedali Civili di Brescia - Ematologia

Brescia, , Italy

Site Status

Ospedale Businco - Divisione di Ematologia

Cagliari, , Italy

Site Status

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

Cuneo, , Italy

Site Status

A.O. UNIVERSITARIA CAREGGI DI FIRENZE - Unità funzionale di Ematologia

Florence, , Italy

Site Status

ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia

Miano, , Italy

Site Status

Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia

Milan, , Italy

Site Status

AOU Maggiore della Caritа di Novara - SCDU Ematologia

Novara, , Italy

Site Status

IRCCS ISTITUTO ONCOLOGICO VENETO (IOV) - Oncologia 1

Padua, , Italy

Site Status

IRCCS Policlinico San Matteo - Divisione di Ematologia

Pavia, , Italy

Site Status

Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare

Roma, , Italy

Site Status

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

Roma, , Italy

Site Status

Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia

Roma, , Italy

Site Status

AOU Senese - U.O.C. Ematologia

Siena, , Italy

Site Status

A.O. UNIVERSITARIA CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - SC Ematologia

Torino, , Italy

Site Status

A.O. Città della Salute e della Scienza - Ematologia Universitaria

Torino, , Italy

Site Status

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica

Udine, , Italy

Site Status

ULSS 8 Berica - Ospedale S. Bortolo - Ematologia

Vicenza, , Italy

Site Status

Countries

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Italy

Other Identifiers

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FIL_PTLD

Identifier Type: -

Identifier Source: org_study_id

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