PTLD: Multicentric Retrospective Study

PTLD Clinical Trial

— FIL_PTLD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06422715
• Other study ID #: FIL_PTLD
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: January 2026

Study information

• Verified date: May 2024
• Source: Fondazione Italiana Linfomi - ETS
• Contact: Uffici Studi FIL
• Phone: 0131033153
• Email: startup[@]filinf.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoproliferative Disorders
• PTLD

Locations

Country	Name	City	State
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	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Ematologia	Milano	MI
Italy	Istituto Scientifico San Raffaele - Unit? Linfomi - Dipartimento Oncoematologia	Milano
Italy	AOU Maggiore della Carit? di Novara - SCDU Ematologia	Novara
Italy	IRCCS ISTITUTO ONCOLOGICO VENETO (IOV) - Oncologia 1	Padova
Italy	IRCCS Policlinico San Matteo - Divisione di Ematologia	Pavia
Italy	Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università "La Sapienza" Istituto Ematologia	Roma
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia	Roma
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. Città della Salute e della Scienza - Ematologia Universitaria	Torino
Italy	A.O. UNIVERSITARIA CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - SC Ematologia	Torino
Italy	Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica	Udine
Italy	ULSS 8 Berica - Ospedale S. Bortolo - Ematologia	Vicenza

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi - ETS	Pierre Fabre Pharma AG

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Overall Survival	survival after PTLD incidence rating	from diagnosis of PTLD to patient's death / last FUP - up to 18 months.
Primary	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	from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Secondary	Rate of Progression Free Survival	compare outcomes according to treatment approaches	from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Secondary	Overall Response Rate	investigate potential treatment effect modifications on outcomes according to patient characteristics	from treatment of PTLD to patient's death / last FUP - up to 18 months.
Secondary	Complete Response Rate to first and subsequent treatments	investigate potential treatment effect modifications on outcomes according to patient	from treatment of PTLD to patient's death / last FUP - up to 18 months.
Secondary	Overall Survival stratified by prognostic factors	Overall Survival assessment stratified by prognostic factors (EBV, LDH, IPI, age, type of transplant)	from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Secondary	Progression Free Survival stratified by prognostic factors	Progression Free Survival assessment stratified by prognostic factors (EBV, LDH, IPI, age, type of transplant)	from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.