PTLDFIL_PTLDNCT06422715
PTLD: Multicentric Retrospective Study
An observational study of PTLD, run by Fondazione Italiana Linfomi - ETS at 21 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTLD
- How many people
- 241 participants
- Where
- 21 sitesItaly
- Study dates
- 30 Oct 2024to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- 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.
Who may be able to join
- 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).
Who cannot join
- Patients not meeting the above-mentioned inclusion criteria.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Italy21 sites
Centro Di Riferimento Oncologico Di Aviano, S.O.C. Oncologia Medica e dei Tumori Immunocorrelati
Aviano
Azienda Ospedaliera Papa Giovanni XXIII - Ematologia
Bergamo, 24127
A.O. UNIVERSITARIA POLICLINICO S.ORSOLA-MALPIGHI DI BOLOGNA - Istituto di Ematologia "Seragnoli"
Bologna, 40138
A.O. Spedali Civili di Brescia - Ematologia
Brescia
Ospedale Businco - Divisione di Ematologia
Cagliari
A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo
Cuneo
A.O. UNIVERSITARIA CAREGGI DI FIRENZE - Unità funzionale di Ematologia
Florence, 50139
ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Miano
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Ematologia
Milan, MI, 20122
Istituto Scientifico San Raffaele - Unitа Linfomi - Dipartimento Oncoematologia
Milan, 20132
AOU Maggiore della Caritа di Novara - SCDU Ematologia
Novara
IRCCS ISTITUTO ONCOLOGICO VENETO (IOV) - Oncologia 1
Padova, 35128
IRCCS Policlinico San Matteo - Divisione di Ematologia
Pavia
Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
Roma, 00128
Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università "La Sapienza" Istituto Ematologia
Roma, 00161
Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica S. Cuore - Ematologia
Roma
AOU Senese - U.O.C. Ematologia
Siena, 53100
A.O. UNIVERSITARIA CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - SC Ematologia
Torino, 10126
A.O. Città della Salute e della Scienza - Ematologia Universitaria
Torino
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC) - SOC Clinica Ematologica
Udine, 33100
ULSS 8 Berica - Ospedale S. Bortolo - Ematologia
Vicenza, 36100
About this study
Official title: Post-transplant Lymphoproliferative Disorders (PTLD): Multicentric Observational Retrospective Cohort 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.
Read the 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
- PTLD
- Keywords
- PTLD, lymphoproliferative disorders, transplant
- Medical subject headings
- Lymphoproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with histological diagnosis of PTLD | 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)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Overall Survival
survival after PTLD incidence rating
Measured: from diagnosis of PTLD to patient's death / last FUP - up to 18 months.
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
Measured: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Secondary outcomes (5)
Rate of Progression Free Survival
compare outcomes according to treatment approaches
Measured: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Overall Response Rate
investigate potential treatment effect modifications on outcomes according to patient characteristics
Measured: from treatment of PTLD to patient's death / last FUP - up to 18 months.
Complete Response Rate to first and subsequent treatments
investigate potential treatment effect modifications on outcomes according to patient
Measured: from treatment of PTLD to patient's death / last FUP - up to 18 months.
Overall Survival stratified by prognostic factors
Overall Survival assessment stratified by prognostic factors (EBV, LDH, IPI, age, type of transplant)
Measured: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Progression Free Survival stratified by prognostic factors
Progression Free Survival assessment stratified by prognostic factors (EBV, LDH, IPI, age, type of transplant)
Measured: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start30 Oct 2024
- Primary completion12 Aug 2025
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Pierre Fabre Pharma AG
- Responsible party
- Sponsor
- Investigators
- Federica Cavallo, MD, Principal investigator, Ematologia Universitaria - A.O.U. Citta della Salute e della Scienza di Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422715
- Sponsor's protocol ID
- FIL_PTLD
- Acronym
- FIL_PTLD
- Status last verified
- Dec 2025
- First submitted
- 7 May 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-transplant Lymphoproliferative Disorders (PTLD): Multicentric Observational Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06422715
- Acronym / sponsor ID
- FIL_PTLD / FIL_PTLD
- Conditions
- PTLD
- Keywords
- PTLD, lymphoproliferative disorders, transplant
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Collaborators
- Pierre Fabre Pharma AG
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- Jan 2026 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with histological diagnosis of PTLD | – | –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)) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- Patients not meeting the above-mentioned inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
5 secondary outcomes
Rate of Progression Free Survival
Time frame: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Overall Response Rate
Time frame: from treatment of PTLD to patient's death / last FUP - up to 18 months.
Complete Response Rate to first and subsequent treatments
Time frame: from treatment of PTLD to patient's death / last FUP - up to 18 months.
Overall Survival stratified by prognostic factors
Time frame: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Progression Free Survival stratified by prognostic factors
Time frame: from diagnosis of PTLD to patient's death/ last FUP - up to 18 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
Related trials for PTLD
Active, not recruitingPhase 1
Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia
B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma, B-Cell Prolymphocytic Leukemia
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
RecruitingPhase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
Not yet recruitingPhase 1/2
Loncastuximab Tesirine and Rituximab as First-line Therapy in Patients With Post-transplant Lymphoproliferative Disorder (PLUTO)
Post-transplant Lymphoproliferative Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Federica Cavallo, MD principal investigator
Ematologia Universitaria - A.O.U. Citta della Salute e della Scienza di Torino
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTLD, run by Fondazione Italiana Linfomi - ETS at 21 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Overall Survival (time frame: from diagnosis of PTLD to patient's death / last FUP - up to 18 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.