Primary Mediastinal Large B-cell Lymphoma With CNS Involvement

Primary Mediastinal Large B-cell Lymphoma (PMBCL) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06024694
• Other study ID #: Observational Retrospective
• Status: Recruiting
• Start date: June 10, 2022
• Est. completion date: June 10, 2024

Study information

• Verified date: August 2023
• Source: IRCCS San Raffaele
• Contact: Andres Ferreri
• Phone: 0226435603
• Email: ferreri.clinicaltrials[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 10, 2024
• Est. primary completion date: June 10, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Primary Mediastinal Large B-cell Lymphoma (PMBCL)

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View Citation

Bishop 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. — View Citation

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. — View Citation

Falini 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. — View 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. — View Citation

Swerdlow 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. — View Citation

Zinzani 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 YEARS
Primary	Clinical characteristics 2	to correlate treatment strategy with survival end-points	2 YEARS
Primary	Clinical characteristics 3	to evaluate the Progression Free Survical ( PFS) after CNS events	2 YEARS
Primary	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	2 YEARS