Clinical trial NCT06422715: PTLD: Multicentric Retrospective Study
Official title: Post-transplant Lymphoproliferative Disorders (PTLD): Multicentric Observational Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: PTLD
Keywords: PTLD
lymphoproliferative disorders
transplant
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
Collaborators: name: Pierre Fabre Pharma AG
First posted: 2024-05-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Overall Survival
timeFrame: from diagnosis of PTLD to patient's death / last FUP - up to 18 months.
measure: clinical and epidemiological features
timeFrame: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Secondary outcomes:
measure: Rate of Progression Free Survival
timeFrame: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
measure: Overall Response Rate
timeFrame: from treatment of PTLD to patient's death / last FUP - up to 18 months.
measure: Complete Response Rate to first and subsequent treatments
timeFrame: from treatment of PTLD to patient's death / last FUP - up to 18 months.
measure: Overall Survival stratified by prognostic factors
timeFrame: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
measure: Progression Free Survival stratified by prognostic factors
timeFrame: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Ematologia
state: MI
city: Ancona
country: Italy
facility: A.O. UNIVERSITARIA OSPEDALI RIUNITI - OSPEDALE UMBERTO I DI ANCONA - Clinica di Ematologia
city: Aviano
country: Italy
facility: Centro Di Riferimento Oncologico Di Aviano, S.O.C. Oncologia Medica e dei Tumori Immunocorrelati
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Papa Giovanni XXIII - Ematologia
city: Bologna
country: Italy
facility: A.O. UNIVERSITARIA POLICLINICO S.ORSOLA-MALPIGHI DI BOLOGNA - Istituto di Ematologia "Seragnoli"
city: Brescia
country: Italy
facility: A.O. Spedali Civili di Brescia - Ematologia
city: Cagliari
country: Italy
facility: Ospedale Businco - Divisione di Ematologia
city: Cuneo
country: Italy
facility: A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo
city: Firenze
country: Italy
facility: A.O. UNIVERSITARIA CAREGGI DI FIRENZE - Unità funzionale di Ematologia
city: Miano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
city: Milano
country: Italy
facility: Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia
city: Novara
country: Italy
facility: AOU Maggiore della Caritа di Novara - SCDU Ematologia
city: Padova
country: Italy
facility: IRCCS ISTITUTO ONCOLOGICO VENETO (IOV) - Oncologia 1
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo - Divisione di Ematologia
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
city: Roma
country: Italy
facility: Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università "La Sapienza" Istituto Ematologia
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia
city: Siena
country: Italy
facility: AOU Senese - U.O.C. Ematologia
city: Torino
country: Italy
facility: A.O. UNIVERSITARIA CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - SC Ematologia
city: Torino
country: Italy
facility: A.O. Città della Salute e della Scienza - Ematologia Universitaria
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica
city: Vicenza
country: Italy
facility: ULSS 8 Berica - Ospedale S. Bortolo - Ematologia
Study officials:
affiliation: Ematologia Universitaria - A.O.U. Citta della Salute e della Scienza di Torino
name: Federica Cavallo, MD
role: PRINCIPAL_INVESTIGATOR
References: