PTLD: Multicentric Retrospective Study

NCT06422715 | Active Not Recruiting

• 1 other identifier: FIL_PTLD
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

PTLD

Keywords

PTLD; lymphoproliferative disorders; transplant

Outcome Measures

Primary Outcomes (2)

• Rate of Overall Survival

  survival after PTLD incidence rating

  from diagnosis of PTLD to patient's death / last FUP - up to 18 months.

• clinical and epidemiological features

  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 Outcomes (5)

• Rate of Progression Free Survival

  from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.

• Overall Response Rate

  from treatment of PTLD to patient's death / last FUP - up to 18 months.

• Complete Response Rate to first and subsequent treatments

  from treatment of PTLD to patient's death / last FUP - up to 18 months.

• Overall Survival stratified by prognostic factors

  from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.

• Progression Free Survival stratified by prognostic factors

  from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.

Study Arms (1)

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))

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead
• Pierre Fabre Pharma AG: collaborator

Study Sites (21)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Ematologia

Milan, MI, 20122, Italy

Location

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

Aviano, Italy

Location

Azienda Ospedaliera Papa Giovanni XXIII - Ematologia

Bergamo, 24127, Italy

Location

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

Bologna, 40138, Italy

Location

A.O. Spedali Civili di Brescia - Ematologia

Brescia, Italy

Location

Ospedale Businco - Divisione di Ematologia

Cagliari, Italy

Location

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

Cuneo, Italy

Location

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

Florence, 50139, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia

Miano, Italy

Location

Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia

Milan, 20132, Italy

Location

AOU Maggiore della Caritа di Novara - SCDU Ematologia

Novara, Italy

Location

IRCCS ISTITUTO ONCOLOGICO VENETO (IOV) - Oncologia 1

Padua, 35128, Italy

Location

IRCCS Policlinico San Matteo - Divisione di Ematologia

Pavia, Italy

Location

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

Roma, 00128, Italy

Location

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

Roma, 00161, Italy

Location

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

Roma, Italy

Location

AOU Senese - U.O.C. Ematologia

Siena, 53100, Italy

Location

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

Torino, 10126, Italy

Location

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

Torino, Italy

Location

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

Udine, 33100, Italy

Location

ULSS 8 Berica - Ospedale S. Bortolo - Ematologia

Vicenza, 36100, Italy

Location

MeSH Terms

Conditions

Lymphoproliferative Disorders

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Federica Cavallo, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 21, 2024
• Study Start: October 30, 2024
• Primary Completion: August 12, 2025
• Study Completion: January 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-12

Locations

IT (21)