Primary Mediastinal Large B-cell Lymphoma (PMBCL)NCT05162170
Primary Mediastinal Large B-cell Lymphoma (PMBCL): Multicenter Retrospective Study
An observational study of Primary Mediastinal Large B-cell Lymphoma (PMBCL), run by Fondazione Italiana Linfomi - ETS at 40 sites in Italy.
Trial summary
The present study consists of a retrospective multicentric collection of all consecutive patients with PMBCL diagnosed over the time period considered (13 years, from 2007 to 2019 inclusive). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Mediastinal Large B-cell Lymphoma (PMBCL)
- How many people
- 633 participants
- Where
- 40 sitesItaly
- Study dates
- 2 Oct 2019to 11 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients newly diagnosed with PMBCL between 01 January 2007 and 31 December 2019 attending participating centres.
Who may be able to join
- All consecutive patients treated in the centre during the period considered
- Age>=18 years
- Histological diagnosis of PMBCL
- Signature of "Informed Consent" to participate in the study (if applicable)
- Treatment according to local practice
- Diagnosis between 01 January 2007 and 31 December 2019
Who cannot join
- The exclusion criteria, being an observational study, are focused and limited to excluding cases with a non-compliant histological diagnosis.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Italy40 sites
SC Ematologia, A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, 15121
Clinica di Ematologia, AOU Ospedali Riuniti
Ancona, 60126
Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico
Avellino, 83100
Divisione di Oncologia e dei Tumori immuno-correlati, IRCCS Centro di Riferimento Oncologico di Aviano
Aviano, 33081
U.O. Ematologia con Trapianto, AOU Policlinico Consorziale
Bari, 70124
U.O.C. Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
Bari, 70124
Ematologia, Ospedale "Monsignor Raffaele Dimiccoli"
Barletta, 76121
Istituto di Ematologia "Seragnoli", Policlinico S.Orsola-Malpighi
Bologna, 40138
Ematologia, ASST Spedali Civili di Brescia
Brescia, 25123
U.O. Ematologia e Trapianti di Midollo, Ospedale Antonio Perrino
Brindisi, 72100
SC Ematologia e CTMO, Ospedale Businco
Cagliari, 09121
Arnas Nuovo Ospedale Garibaldi Nesima
Catania, 95122
Ematologia, Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele Presidio Ospedale Ferrarotto
Catania, 95124
UOC Ematologia, Azienda Ospedaliera di Cosenza
Cosenza, 87100
Unitа funzionale di Ematologia, Azienda Ospedaliera Universitaria Careggi
Florence, 50141
Ematologia, Ospedale Vito Fazzi
Lecce, 73100
Ematologia, Ospedale Madonna delle Grazie
Matera, 75100
SC Ematologia, Azienda Ospedali Riuniti Papardo-Piemonte
Messina, 98158
Ematologia, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, 20133
Divisione Ematoncologia, IEO Istitito Europeo di Oncologia
Milan, 20141
SC Ematologia, ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
UOC Ematologia Oncologica, Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale
Naples, 80131
Istituto Oncologico Veneto I.R.C.C.S.
Padova, 35128
Ematologia, AOU Policlinico Giaccone
Palermo, 90127
Divisione di Ematologia, A.O. Ospedali Riuniti Villa Sofia-Cervello
Palermo, 90146
Oncoematologia e TMO Dip. Oncologia, Casa di Cura La Maddalena
Palermo, 90146
Azienda Ospedaliera Universitaria Pisana - U.O. Ematologia
Pisa, 56126
Ematologia, Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria, 89124
Ematologia, Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia, 42123
Ematologia, Ospedale S. Camillo
Roma, 00152
Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione,Policlinico Umberto I - Universitа "La Sapienza"
Roma, 00161
Ematologia, Universitа Cattolica S. Cuore
Roma, 00168
UO Ematologia, Istituto Clinico Humanitas
Rozzano, 20089
UO Ematologia, Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013
SC Ematologia, Ospedale "S.G. Moscati"
Taranto, 74010
Azienda Ospedaliera Santa Maria - S.C. Oncoematologia
Terni, 05100
Ematologia Universitaria, A.O.U. Citta della Salute e della Scienza di Torino
Torino, 10126
SC Ematologia, A.O.U. Citta della Salute e della Scienza di Torino
Torino, 10126
UO Ematologia, AOU Integrata di Verona
Verona, 37134
U.F. Oncoematologia, IOM (Istituto Oncologico del Mediterraneo)
Viagrande, Catania, 95029
About this study
Official title: Primary Mediastinal Large B-cell Lymphoma (PMBCL): Multicenter Retrospective Study by the Fondazione Italiana Linfomi.
The present study consists of a retrospective multicentric collection of all consecutive patients with PMBCL diagnosed over the time period considered (13 years, from 2007 to 2019 inclusive).
Read the detailed description
The study was initially set up as a spontaneous, non-profit study, with ARNAS Garibaldi of Catania (PI Dr Ugo Consoli) as the proposer. Subsequently, the project was expanded to include additional centres belonging to the Italian Lymphoma Foundation, which became the promoter in collaboration with ARNAS Garibaldi of Catania. The information collected is aimed at verifying the application in a "real world" context of the PMBCL diagnosis and therapy protocols suggested in the guidelines and at checking whether they produce results in line with those expected.
The therapies considered for the I line of treatment are those described in the literature for the pathology under consideration:
- R-CHOP14; R-CHOP21 and R-CHOP like, (R-CHOP: rituximab - cyclophosphamide, doxorubicin, vincristine, prednisone)
- R-VACOPB, R-MACOPB and R-VACOPB like, MACOPB like, (R-VACOP-B: Rituximab - etoposide, doxorubicin, cyclophosphamide, vincristine, prednisone, bleomycin. R-MACOP-B: Rituximab - methotrexate, doxorubicin, cyclophosphamide, vincristine, prednisone, bleomycin)
- R-DA-EPOCH ed R-EPOCH like (DA-R- EPOCH: Dose Adjusted - Rituximab - Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin)
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 |
|---|---|---|
| Primary Mediastinal large B-Cell Lymphoma (PMBCL) | The present study consists of a retrospective multicenter collection of series of consecutive patients diagnosed with PMBCL over the relevant time period (13 years, from 2007 to 2019 included). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of primary/early refractory disease
The study aims to evaluate the rate of primary/early refractory disease (Primary mediastinal large B-cell lymphoma)
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Overall response rate (ORR)
Overall Response Rate is defined as the percentage of patients in complete remission or in partial remission
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Complete response rate (CRR)
The Complete Response Rate is defined as the percentage of patient in Complete Remission
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Frequency of administration of mediastinal radiation therapy
Analyze the frequency of administration of mediastinal radiation therapy in patients affected by primary mediastinal large B-cell lymphoma
Measured: four months after completion of chemotherapy
Progression Free Survival (PFS)
The length of time during and after the treatment that patients live with the disease, but it does not get worse. Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause.
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Overall Survival (OS)
Overall Survival, the percentage of patients alive, is defined from the start date of therapy to the date of death from any cause.
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Secondary outcomes (2)
Acute toxicity
Analyze incidence and type of acute toxicity (haematological and extra haematological toxicity)
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Long-term toxicity
Analyze incidence and type of long-term toxicity (cardiological toxicity and second tumors)
Measured: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start2 Oct 2019
- Primary completion5 Dec 2022
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Mediastinal Large B-cell Lymphoma (PMBCL)Studies 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
- 633 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Italiana Linfomi - ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ugo Consoli, Principal investigator, U.O.C Ematologia, ARNAS Garibaldi; P.O. Garibaldi - Nesima, Catania.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162170
- Sponsor's protocol ID
- FIL_PMBCL
- Status last verified
- May 2026
- First submitted
- 26 Nov 2021
- Last updated
- 1 Jun 2026
- 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 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Mediastinal Large B-cell Lymphoma (PMBCL): Multicenter Retrospective Study by the Fondazione Italiana Linfomi.
- ClinicalTrials.gov ID
- NCT05162170
- Acronym / sponsor ID
- FIL_PMBCL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 633 participants (actual)
- Lead sponsor
- Fondazione Italiana Linfomi - ETSUniversity, hospital or other
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 17 Dec 2021 (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.
The present study consists of a retrospective multicentric collection of all consecutive patients with PMBCL diagnosed over the time period considered (13 years, from 2007 to 2019 inclusive).
Detailed description
The study was initially set up as a spontaneous, non-profit study, with ARNAS Garibaldi of Catania (PI Dr Ugo Consoli) as the proposer. Subsequently, the project was expanded to include additional centres belonging to the Italian Lymphoma Foundation, which became the promoter in collaboration with ARNAS Garibaldi of Catania. The information collected is aimed at verifying the application in a "real world" context of the PMBCL diagnosis and therapy protocols suggested in the guidelines and at checking whether they produce results in line with those expected.
The therapies considered for the I line of treatment are those described in the literature for the pathology under consideration:
- R-CHOP14; R-CHOP21 and R-CHOP like, (R-CHOP: rituximab - cyclophosphamide, doxorubicin, vincristine, prednisone)
- R-VACOPB, R-MACOPB and R-VACOPB like, MACOPB like, (R-VACOP-B: Rituximab - etoposide, doxorubicin, cyclophosphamide, vincristine, prednisone, bleomycin. R-MACOP-B: Rituximab - methotrexate, doxorubicin, cyclophosphamide, vincristine, prednisone, bleomycin)
- R-DA-EPOCH ed R-EPOCH like (DA-R- EPOCH: Dose Adjusted - Rituximab - Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Mediastinal large B-Cell Lymphoma (PMBCL) | – | –The present study consists of a retrospective multicenter collection of series of consecutive patients diagnosed with PMBCL over the relevant time period (13 years, from 2007 to 2019 included). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients newly diagnosed with PMBCL between 01 January 2007 and 31 December 2019 attending participating centres.
Key inclusion criteria (6 listed)
- All consecutive patients treated in the centre during the period considered
- Age>=18 years
- Histological diagnosis of PMBCL
- Signature of "Informed Consent" to participate in the study (if applicable)
- Treatment according to local practice
Key exclusion criteria (1 listed)
- The exclusion criteria, being an observational study, are focused and limited to excluding cases with a non-compliant histological diagnosis.
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 primary/early refractory disease
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
The study aims to evaluate the rate of primary/early refractory disease (Primary mediastinal large B-cell lymphoma)
Overall response rate (ORR)
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Overall Response Rate is defined as the percentage of patients in complete remission or in partial remission
Complete response rate (CRR)
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
The Complete Response Rate is defined as the percentage of patient in Complete Remission
Frequency of administration of mediastinal radiation therapy
Time frame: four months after completion of chemotherapy
Analyze the frequency of administration of mediastinal radiation therapy in patients affected by primary mediastinal large B-cell lymphoma
Progression Free Survival (PFS)
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
The length of time during and after the treatment that patients live with the disease, but it does not get worse. Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause.
Overall Survival (OS)
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Overall Survival, the percentage of patients alive, is defined from the start date of therapy to the date of death from any cause.
2 secondary outcomes
Acute toxicity
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Long-term toxicity
Time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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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.
Ugo Consoli principal investigator
U.O.C Ematologia, ARNAS Garibaldi; P.O. Garibaldi - Nesima, Catania.
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Mediastinal Large B-cell Lymphoma (PMBCL), run by Fondazione Italiana Linfomi - ETS at 40 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 6 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: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 primary/early refractory disease (time frame: The endpoint will be evaluated from the beginning to the end of the study (up to 24 months)). The study lists 6 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 1 Jun 2026.