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Active, Not Recruiting

NCT Number: NCT06422715

PTLD: Multicentric Retrospective 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Ematologia, Milan, MI, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Fondazione Italiana Linfomi - ETS

Other

Collaborators

  • Pierre Fabre Pharma AG

Registry information

Official study title

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

Acronym: FIL_PTLD

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 21, 2024
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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