PTLD: Multicentric Retrospective Study
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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).
- 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)
Centro Di Riferimento Oncologico Di Aviano, S.O.C. Oncologia Medica e dei Tumori Immunocorrelati
🇮🇹Aviano, Italy
A.O. Spedali Civili di Brescia - Ematologia
🇮🇹Brescia, Italy
Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia
🇮🇹Milano, Italy
AOU Maggiore della Caritа di Novara - SCDU Ematologia
🇮🇹Novara, Italy
IRCCS ISTITUTO ONCOLOGICO VENETO (IOV) - Oncologia 1
🇮🇹Padova, Italy
IRCCS Policlinico San Matteo - Divisione di Ematologia
🇮🇹Pavia, Italy
Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
🇮🇹Roma, Italy
AOU Senese - U.O.C. Ematologia
🇮🇹Siena, Italy
A.O. UNIVERSITARIA CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - SC Ematologia
🇮🇹Torino, Italy
Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università "La Sapienza" Istituto Ematologia
🇮🇹Roma, Italy
A.O. Città della Salute e della Scienza - Ematologia Universitaria
🇮🇹Torino, Italy
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica
🇮🇹Udine, Italy
ULSS 8 Berica - Ospedale S. Bortolo - Ematologia
🇮🇹Vicenza, Italy
A.O. UNIVERSITARIA POLICLINICO S.ORSOLA-MALPIGHI DI BOLOGNA - Istituto di Ematologia "Seragnoli"
🇮🇹Bologna, 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
Azienda Ospedaliera Papa Giovanni XXIII - Ematologia
🇮🇹Bergamo, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia
🇮🇹Roma, Italy
Ospedale Businco - Divisione di Ematologia
🇮🇹Cagliari, Italy
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
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
🇮🇹Miano, Italy