## Protocol Section
### Identification Module
**NCT ID:** NCT06422715

**Acronym:** FIL_PTLD

**Brief Title:** PTLD: Multicentric Retrospective Study

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

#### Organization Study ID Info
**ID:** FIL_PTLD
#### Organization
**Class:** OTHER
**Full Name:** Fondazione Italiana Linfomi - ETS
### Status Module
#### Completion Date
**Date:** 2026-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Pierre Fabre Pharma AG

#### Lead Sponsor

**Class:** OTHER

**Name:** Fondazione Italiana Linfomi - ETS

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- PTLD

**Keywords:**

- PTLD

- lymphoproliferative disorders

- transplant

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** patients with histological diagnosis obtained from a biopsy sample in 10 years' time frame (from 01/01/2011 to 31/12/2021) of PTLD (from allogeneic transplantation (both SOT and HSCT))

**Label:** patients with histological diagnosis of PTLD

### Outcomes Module

#### Primary Outcomes

**Description:** survival after PTLD incidence rating

**Measure:** Rate of Overall Survival

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

**Description:** 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

**Measure:** clinical and epidemiological features

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

#### Secondary Outcomes

**Description:** compare outcomes according to treatment approaches

**Measure:** Rate of Progression Free Survival

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

**Description:** investigate potential treatment effect modifications on outcomes according to patient characteristics

**Measure:** Overall Response Rate

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

**Description:** investigate potential treatment effect modifications on outcomes according to patient

**Measure:** Complete Response Rate to first and subsequent treatments

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

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

**Measure:** Overall Survival stratified by prognostic factors

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

**Description:** Progression Free Survival assessment stratified by prognostic factors (EBV, LDH, IPI, age, type of transplant)

**Measure:** Progression Free Survival stratified by prognostic factors

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

### Eligibility Module

**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.

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** startup@filinf.it

**Name:** Uffici Studi FIL

**Phone:** 0131033153

**Role:** CONTACT

**Contact 2:**

**Email:** gestionestudi@filinf.it

**Name:** Uffici Studi FIL

**Phone:** 059 976 9910

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Milano

**Country:** Italy

**Facility:** Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Ematologia

**State:** MI

**Zip:** 20122

**Location 2:**

**City:** Ancona

**Country:** Italy

**Facility:** A.O. UNIVERSITARIA OSPEDALI RIUNITI - OSPEDALE UMBERTO I DI ANCONA - Clinica di Ematologia

**Zip:** 60126

**Location 3:**

**City:** Aviano

**Country:** Italy

**Facility:** Centro Di Riferimento Oncologico Di Aviano, S.O.C. Oncologia Medica e dei Tumori Immunocorrelati

**Location 4:**

**City:** Bergamo

**Country:** Italy

**Facility:** Azienda Ospedaliera Papa Giovanni XXIII - Ematologia

**Zip:** 24127

**Location 5:**

**City:** Bologna

**Country:** Italy

**Facility:** A.O. UNIVERSITARIA POLICLINICO S.ORSOLA-MALPIGHI DI BOLOGNA - Istituto di Ematologia "Seragnoli"

**Zip:** 40138

**Location 6:**

**City:** Brescia

**Country:** Italy

**Facility:** A.O. Spedali Civili di Brescia - Ematologia

**Location 7:**

**City:** Cagliari

**Country:** Italy

**Facility:** Ospedale Businco - Divisione di Ematologia

**Location 8:**

**City:** Cuneo

**Country:** Italy

**Facility:** A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo

**Location 9:**

**City:** Firenze

**Country:** Italy

**Facility:** A.O. UNIVERSITARIA CAREGGI DI FIRENZE - Unità funzionale di Ematologia

**Zip:** 50139

**Location 10:**

**City:** Miano

**Country:** Italy

**Facility:** ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia

**Location 11:**

**City:** Milano

**Country:** Italy

**Facility:** Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia

**Zip:** 20132

**Location 12:**

**City:** Novara

**Country:** Italy

**Facility:** AOU Maggiore della Caritа di Novara - SCDU Ematologia

**Location 13:**

**City:** Padova

**Country:** Italy

**Facility:** IRCCS ISTITUTO ONCOLOGICO VENETO (IOV) - Oncologia 1

**Zip:** 35128

**Location 14:**

**City:** Pavia

**Country:** Italy

**Facility:** IRCCS Policlinico San Matteo - Divisione di Ematologia

**Location 15:**

**City:** Roma

**Country:** Italy

**Facility:** Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare

**Zip:** 00128

**Location 16:**

**City:** Roma

**Country:** Italy

**Facility:** Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università "La Sapienza" Istituto Ematologia

**Zip:** 00161

**Location 17:**

**City:** Roma

**Country:** Italy

**Facility:** Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia

**Location 18:**

**City:** Siena

**Country:** Italy

**Facility:** AOU Senese - U.O.C. Ematologia

**Zip:** 53100

**Location 19:**

**City:** Torino

**Country:** Italy

**Facility:** A.O. UNIVERSITARIA CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - SC Ematologia

**Zip:** 10126

**Location 20:**

**City:** Torino

**Country:** Italy

**Facility:** A.O. Città della Salute e della Scienza - Ematologia Universitaria

**Location 21:**

**City:** Udine

**Country:** Italy

**Facility:** Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica

**Zip:** 33100

**Location 22:**

**City:** Vicenza

**Country:** Italy

**Facility:** ULSS 8 Berica - Ospedale S. Bortolo - Ematologia

**Zip:** 36100

#### Overall Officials

**Official 1:**

**Affiliation:** Ematologia Universitaria - A.O.U. Citta della Salute e della Scienza di Torino

**Name:** Federica Cavallo, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: HIGH

- As Found: Lymphoproliferative Disorders

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4650

- Name: Post-transplant Lymphoproliferative Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008232

- Term: Lymphoproliferative Disorders

### Misc Info Module

- Version Holder: 2024-05-31
