Primary Mediastinal Large B-cell Lymphoma (PMBCL)NCT06024694
Primary Mediastinal Large B-cell Lymphoma With CNS Involvement
An observational study of Primary Mediastinal Large B-cell Lymphoma (PMBCL), run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This is a retrospective, multicenter study focused on patients with a known diagnosis of PMLBCL which experienced a CNS relapse during the course of their disease to obtain information about the clinical characteristics, the management at diagnosis and at each relapses , and the outcome of these cases. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Mediastinal Large B-cell Lymphoma (PMBCL)
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jun 2022to 10 Jun 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients whose diagnosis met the histological criteria of PMLBL according WHO classification with a diagnosis of CNS involvement at relapse/progression. Patients eligible to the study will be retrospectively identified by the site researches by interrogating the local site sources. Availability of local pathological report at time of diagnosis and restaging will be considered for eligibility.
Who may be able to join
- Histologically confirmed diagnosis of Primary Mediastinal Large B Cell Lymphoma (PMLBCL) according WHO Classification
- Had a recurrence/progression with Central Nervous System (CNS) involvement
- Availability of details on clinical presentation, treatment details and outcome
- Availability of details on pathological data for central review
- Age ≥18 years
Who cannot join
- Patients with CNS lymphoma other than PMLBCL subtype
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Multicenter International Study on Prognostic Factors, Management And Outcome Of Primary Mediastinal Large B-Cell Lymphoma (PMLBCL) Patients With Central Nervous System (CNS) Involvement
This is a retrospective, multicenter study focused on patients with a known diagnosis of PMLBCL which experienced a CNS relapse during the course of their disease to obtain information about the clinical characteristics, the management at diagnosis and at each relapses , and the outcome of these cases. The aim of the study is to put together the large International series on CNS+ PMLBCL data, coming from 6 different countries , on clinical factors, anti-lymphoma therapy administered alone or concomitant with CNS prophylaxis , the information about the site of re biopsy when available , the dose intensity of lymphoma therapy received at relapse and the outcome of patients.
Both patients treated in routine practice or within clinical trials will be considered. Moreover to better characterized the pathological features of this rare entity a central pathological review of the initial diagnosis and when available of for histological confirmed relapse will be considered.
- Keywords
- CNS, PMLBCL
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 diagnosed with PMLBL | Patients whose diagnosis met the histological criteria of PMLBL according WHO classification with a diagnosis of CNS involvement at relapse/progression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical characteristics 1
to describe the PMLBCL characteristics at diagnosis and at CNS relapse ( first relapse or second and subsequent recurrences) and the treatment received to describe the median time to CNS relapse to define prognostic factors of outcome of CNS relapse in PMLBCL patients
Measured: 2 YEARS
Clinical characteristics 2
to correlate treatment strategy with survival end-points
Measured: 2 YEARS
Clinical characteristics 3
to evaluate the Progression Free Survical ( PFS) after CNS events
Measured: 2 YEARS
Clinical characteristics 4
to evaluate Overall Survival ( OS) after CNS relapse to centra! pathological reviewed the initial diagnosis and the relapse and to correlate biological and molecular factors with CNS recurrence
Measured: 2 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start30 Jun 2022
- Primary completion10 Jun 2026 (estimated)
- Study completion10 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrés José Maria Ferreri, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024694
- Sponsor's protocol ID
- OSR PMLBCL SNC+
- Status last verified
- Jun 2025
- First submitted
- 24 Aug 2022
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cazals-Hatem D, Lepage E, Brice P, Ferrant A, d'Agay MF, Baumelou E, Briere J, Blanc M, Gaulard P, Biron P, Schlaifer D, Diebold J, Audouin J. Primary mediastinal large B-cell lymphoma. A clinicopathologic study of 141 cases compared with 916 nonmediastinal large B-cell lymphomas, a GELA ("Groupe d'Etude des Lymphomes de l'Adulte") study. Am J Surg Pathol. 1996 Jul;20(7):877-88. doi: 10.1097/00000478-199607000-00012.
PubMed 8669537Falini B, Venturi S, Martelli M, Santucci A, Pileri S, Pescarmona E, Giovannini M, Mazza P, Martelli MF, Pasqualucci L, et al. Mediastinal large B-cell lymphoma: clinical and immunohistological findings in 18 patients treated with different third-generation regimens. Br J Haematol. 1995 Apr;89(4):780-9. doi: 10.1111/j.1365-2141.1995.tb08415.x.
PubMed 7539625Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, Advani R, Ghielmini M, Salles GA, Zelenetz AD, Jaffe ES. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15.
PubMed 26980727Bishop PC, Wilson WH, Pearson D, Janik J, Jaffe ES, Elwood PC. CNS involvement in primary mediastinal large B-cell lymphoma. J Clin Oncol. 1999 Aug;17(8):2479-85. doi: 10.1200/JCO.1999.17.8.2479.
PubMed 10561312Zinzani PL, Martelli M, Bertini M, Gianni AM, Devizzi L, Federico M, Pangalis G, Michels J, Zucca E, Cantonetti M, Cortelazzo S, Wotherspoon A, Ferreri AJ, Zaja F, Lauria F, De Renzo A, Liberati MA, Falini B, Balzarotti M, Calderoni A, Zaccaria A, Gentilini P, Fattori PP, Pavone E, Angelopoulou MK, Alinari L, Brugiatelli M, Di Renzo N, Bonifazi F, Pileri SA, Cavalli F; International Extranodal Lymphoma Study Group (IELSG). Induction chemotherapy strategies for primary mediastinal large B-cell lymphoma with sclerosis: a retrospective multinational study on 426 previously untreated patients. Haematologica. 2002 Dec;87(12):1258-64.
PubMed 12495899Martelli M, Ferreri A, Di Rocco A, Ansuinelli M, Johnson PWM. Primary mediastinal large B-cell lymphoma. Crit Rev Oncol Hematol. 2017 May;113:318-327. doi: 10.1016/j.critrevonc.2017.01.009. Epub 2017 Jan 21.
PubMed 28318892Aoki T, Izutsu K, Suzuki R, Nakaseko C, Arima H, Shimada K, Tomita A, Sasaki M, Takizawa J, Mitani K, Igarashi T, Maeda Y, Fukuhara N, Ishida F, Niitsu N, Ohmachi K, Takasaki H, Nakamura N, Kinoshita T, Nakamura S, Ogura M. Prognostic significance of pleural or pericardial effusion and the implication of optimal treatment in primary mediastinal large B-cell lymphoma: a multicenter retrospective study in Japan. Haematologica. 2014 Dec;99(12):1817-25. doi: 10.3324/haematol.2014.111203. Epub 2014 Sep 12.
PubMed 25216682
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Multicenter International Study on Prognostic Factors, Management And Outcome Of Primary Mediastinal Large B-Cell Lymphoma (PMLBCL) Patients With Central Nervous System (CNS) Involvement
- ClinicalTrials.gov ID
- NCT06024694
- Acronym / sponsor ID
- OSR PMLBCL SNC+
- Keywords
- CNS, PMLBCL
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- 10 Jun 2026 (estimated)
- Study completion
- 10 Jun 2027 (estimated)
- First posted
- 6 Sep 2023 (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 retrospective, multicenter study focused on patients with a known diagnosis of PMLBCL which experienced a CNS relapse during the course of their disease to obtain information about the clinical characteristics, the management at diagnosis and at each relapses , and the outcome of these cases. The aim of the study is to put together the large International series on CNS+ PMLBCL data, coming from 6 different countries , on clinical factors, anti-lymphoma therapy administered alone or concomitant with CNS prophylaxis , the information about the site of re biopsy when available , the dose intensity of lymphoma therapy received at relapse and the outcome of patients.
Both patients treated in routine practice or within clinical trials will be considered. Moreover to better characterized the pathological features of this rare entity a central pathological review of the initial diagnosis and when available of for histological confirmed relapse will be considered.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients diagnosed with PMLBL | – | –Patients whose diagnosis met the histological criteria of PMLBL according WHO classification with a diagnosis of CNS involvement at relapse/progression |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients whose diagnosis met the histological criteria of PMLBL according WHO classification with a diagnosis of CNS involvement at relapse/progression. Patients eligible to the study will be retrospectively identified by the site researches by interrogating the local site sources. Availability of local pathological report at time of diagnosis and restaging will be considered for eligibility.
Key inclusion criteria (5 listed)
- Histologically confirmed diagnosis of Primary Mediastinal Large B Cell Lymphoma (PMLBCL) according WHO Classification
- Had a recurrence/progression with Central Nervous System (CNS) involvement
- Availability of details on clinical presentation, treatment details and outcome
- Availability of details on pathological data for central review
- Age ≥18 years
Key exclusion criteria (1 listed)
- Patients with CNS lymphoma other than PMLBCL subtype
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
Clinical characteristics 1
Time frame: 2 YEARS
to describe the PMLBCL characteristics at diagnosis and at CNS relapse ( first relapse or second and subsequent recurrences) and the treatment received to describe the median time to CNS relapse to define prognostic factors of outcome of CNS relapse in PMLBCL patients
Clinical characteristics 2
Time frame: 2 YEARS
to correlate treatment strategy with survival end-points
Clinical characteristics 3
Time frame: 2 YEARS
to evaluate the Progression Free Survical ( PFS) after CNS events
Clinical characteristics 4
Time frame: 2 YEARS
to evaluate Overall Survival ( OS) after CNS relapse to centra! pathological reviewed the initial diagnosis and the relapse and to correlate biological and molecular factors with CNS recurrence
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 26 Jun 2025.
- Background: PubMed 8669537Cazals-Hatem D, Lepage E, Brice P, Ferrant A, d'Agay MF, Baumelou E, Briere J, Blanc M, Gaulard P, Biron P, Schlaifer D, Diebold J, Audouin J. Primary mediastinal large B-cell lymphoma. A clinicopathologic study of 141 cases compared with 916 nonmediastinal large B-cell lymphomas, a GELA ("Groupe d'Etude des Lymphomes de l'Adulte") study. Am J Surg Pathol. 1996 Jul;20(7):877-88. doi: 10.1097/00000478-199607000-00012.
- Background: PubMed 7539625Falini B, Venturi S, Martelli M, Santucci A, Pileri S, Pescarmona E, Giovannini M, Mazza P, Martelli MF, Pasqualucci L, et al. Mediastinal large B-cell lymphoma: clinical and immunohistological findings in 18 patients treated with different third-generation regimens. Br J Haematol. 1995 Apr;89(4):780-9. doi: 10.1111/j.1365-2141.1995.tb08415.x.
- Background: PubMed 26980727Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, Advani R, Ghielmini M, Salles GA, Zelenetz AD, Jaffe ES. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15.
- Background: PubMed 10561312Bishop PC, Wilson WH, Pearson D, Janik J, Jaffe ES, Elwood PC. CNS involvement in primary mediastinal large B-cell lymphoma. J Clin Oncol. 1999 Aug;17(8):2479-85. doi: 10.1200/JCO.1999.17.8.2479.
- Background: PubMed 12495899Zinzani PL, Martelli M, Bertini M, Gianni AM, Devizzi L, Federico M, Pangalis G, Michels J, Zucca E, Cantonetti M, Cortelazzo S, Wotherspoon A, Ferreri AJ, Zaja F, Lauria F, De Renzo A, Liberati MA, Falini B, Balzarotti M, Calderoni A, Zaccaria A, Gentilini P, Fattori PP, Pavone E, Angelopoulou MK, Alinari L, Brugiatelli M, Di Renzo N, Bonifazi F, Pileri SA, Cavalli F; International Extranodal Lymphoma Study Group (IELSG). Induction chemotherapy strategies for primary mediastinal large B-cell lymphoma with sclerosis: a retrospective multinational study on 426 previously untreated patients. Haematologica. 2002 Dec;87(12):1258-64.
- Background: PubMed 28318892Martelli M, Ferreri A, Di Rocco A, Ansuinelli M, Johnson PWM. Primary mediastinal large B-cell lymphoma. Crit Rev Oncol Hematol. 2017 May;113:318-327. doi: 10.1016/j.critrevonc.2017.01.009. Epub 2017 Jan 21.
- Background: PubMed 25216682Aoki T, Izutsu K, Suzuki R, Nakaseko C, Arima H, Shimada K, Tomita A, Sasaki M, Takizawa J, Mitani K, Igarashi T, Maeda Y, Fukuhara N, Ishida F, Niitsu N, Ohmachi K, Takasaki H, Nakamura N, Kinoshita T, Nakamura S, Ogura M. Prognostic significance of pleural or pericardial effusion and the implication of optimal treatment in primary mediastinal large B-cell lymphoma: a multicenter retrospective study in Japan. Haematologica. 2014 Dec;99(12):1817-25. doi: 10.3324/haematol.2014.111203. Epub 2014 Sep 12.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 IRCCS San Raffaele at 1 site 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 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Clinical characteristics 1 (time frame: 2 YEARS). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06024694, which also lists 7 linked publications.
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 26 Jun 2025.