PTLD: Multicentric Retrospective Study

Not yet recruiting

• Conditions: PTLD

• Registration Number: NCT06422715
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

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.

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 Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-05-20
• Study First Posted: 2024-05-21
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-22
• Study Start: 2024-07
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Overall Survival	from diagnosis of PTLD to patient's death / last FUP - up to 18 months.	survival after PTLD incidence rating
clinical and epidemiological features	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

Secondary Outcome Measures

Name	Time	Method
Rate of Progression Free Survival	from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.	compare outcomes according to treatment approaches
Overall Survival stratified by prognostic factors	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)
Overall Response Rate	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
Progression Free Survival stratified by prognostic factors	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)
Complete Response Rate to first and subsequent treatments	from treatment of PTLD to patient's death / last FUP - up to 18 months.	investigate potential treatment effect modifications on outcomes according to patient

Trial Locations

Locations (22)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Ematologia; 🇮🇹 Milano, MI, Italy

A.O. UNIVERSITARIA OSPEDALI RIUNITI - OSPEDALE UMBERTO I DI ANCONA - Clinica di Ematologia; 🇮🇹 Ancona, Italy

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

Azienda Ospedaliera Papa Giovanni XXIII - Ematologia; 🇮🇹 Bergamo, Italy

A.O. UNIVERSITARIA POLICLINICO S.ORSOLA-MALPIGHI DI BOLOGNA - Istituto di Ematologia "Seragnoli"; 🇮🇹 Bologna, Italy

A.O. Spedali Civili di Brescia - Ematologia; 🇮🇹 Brescia, Italy

Ospedale Businco - Divisione di Ematologia; 🇮🇹 Cagliari, Italy

A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo; 🇮🇹 Cuneo, Italy

A.O. UNIVERSITARIA CAREGGI DI FIRENZE - Unità funzionale di Ematologia; 🇮🇹 Firenze, Italy

ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia; 🇮🇹 Miano, Italy

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