Clinical trial NCT06024694: Primary Mediastinal Large B-cell Lymphoma With CNS Involvement
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Mediastinal Large B-cell Lymphoma (PMBCL)
Keywords: PMBCL
CNS
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief summary: retrospective 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria

* Patients with CNS lymphoma other than PMLBCL subtype

Primary outcomes:
measure: Clinical characteristics 1
timeFrame: 2 YEARS
measure: Clinical characteristics 2
timeFrame: 2 YEARS
measure: Clinical characteristics 3
timeFrame: 2 YEARS
measure: Clinical characteristics 4
timeFrame: 2 YEARS
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Ospedale San Raffaele
Study officials:
References:
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citation: Martelli 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.
citation: Aoki 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.