PTLD: Multicentric Retrospective Study

N/AActive Not RecruitingNCT06422715

Fondazione Italiana Linfomi - ETS241 enrolled

Overview

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.

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

241

Conditions

PTLD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (21)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Ematologia

Outcomes

Primary Outcomes

Rate of Overall Survival

survival after PTLD incidence rating

Time frame: 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

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

Secondary Outcomes

Rate of Progression Free Survival

compare outcomes according to treatment approaches

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

Overall Response Rate

investigate potential treatment effect modifications on outcomes according to patient characteristics

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

Complete Response Rate to first and subsequent treatments

investigate potential treatment effect modifications on outcomes according to patient

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

Overall Survival stratified by prognostic factors

Overall Survival assessment stratified by prognostic factors (EBV, LDH, IPI, age, type of transplant)

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

Data from ClinicalTrials.gov

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