Clinical trial NCT00944567: A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma
Official title: A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Mediastinal B-Cell Lymphoma
Keywords: Primary Mediastinal B-Cell Lymphoma
Positron emission tomography
Lead sponsor: International Extranodal Lymphoma Study Group (IELSG)
Sponsor class: OTHER
First posted: 2009-07-23
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient must have histological confirmation of the diagnodis of primary mediastinal diffuse large B cell lymphoma and have a dominant mass within the anterior mediastinum

Brief summary: A non-profit study designed with the aim of analysing the phenotype and molecular characteristics (central review) and evaluating prospectively the role of PET-scans in the management of primary mediastinal lymphoma treated with conventional approaches.


Eligibility criteria: Inclusion Criteria:

* Primary mediastinal diffuse large B-cell lymphoma, CD20 positive. Patients must have histological confirmation of the diagnosis, and in addition have a dominant mass within the anterior mediastinum.
* No prior treatment of lymphoma. Patients may have received corticosteroids for up to 1 week for the relief of local compressive symptoms.
* Any stage of disease.
* Age at least 18 years.
* Fit to receive chemotherapy with curative intent.
* Able and willing to give informed consent, and to undergo staging including PET scanning
* Willingness to comply with an appropriate contraceptive method in women of childbearing potential or men.

Exclusion Criteria:

* Evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry. Cardiac compromise due to local extension of lymphoma will not be an exclusion criterion in the absence of other cardiac disease.
* Impairment of bone marrow function (WBC \<3.0x109/L, ANC \<1.5x109/L, PLT \<100x109/L), unless due to involvement by lymphoma.
* Major impairment of renal function (serum creatinine \>2x upper normal) or liver function (ASAT/ALAT \>2,5 upper normal, total bilirubin \>2,5x upper normal), unless due to lymphoma involvement.
* Known HIV infection. Patients will not be tested routinely.
* Pregnant or lactating women.
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

Primary outcomes:
measure: response rate on PET scanning following initial chemo-immunotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: A.O. SS. Antonio e Biagio e Cesare Arrigo
city: Bari
country: Italy
facility: IRCCS Ospedale Oncologico
city: Bologna
country: Italy
facility: Policlinico S. Orsola Malpighi
city: Cagliari
country: Italy
facility: Ospedale Oncologico
city: Firenze
country: Italy
facility: Policlinico Careggi
city: Messina
country: Italy
facility: A.O.Papardo
city: Milano
country: Italy
facility: Ospedale Niguarda Ca' Granda
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Modena
country: Italy
facility: Università di Modena, Policlinico
city: Pavia
country: Italy
facility: Policlinico S. Matteo
city: Reggio Calabria
country: Italy
facility: A.O. Bianchi-Melacrino-Morelli
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova
city: Rome
country: Italy
facility: Università di Roma "La Sapienza" - DAI Ematologia
city: Rozzano
country: Italy
facility: Humanitas
city: Torino
country: Italy
facility: Ospedale Maggiore San Giovanni Battista
city: Varese
country: Italy
facility: Ospedale di Circolo Fondazione Macchi
city: Barcelona
country: Spain
facility: Clinic Hospital Universitari
city: Bellinzona
country: Switzerland
facility: IOSI
city: London
country: United Kingdom
facility: Barts & the London NHS Trust
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
Study officials:
References:
citation: Ceriani L, Milan L, Martelli M, Ferreri AJM, Cascione L, Zinzani PL, Di Rocco A, Conconi A, Stathis A, Cavalli F, Bellei M, Cozens K, Porro E, Giovanella L, Johnson PW, Zucca E. Metabolic heterogeneity on baseline 18FDG-PET/CT scan is a predictor of outcome in primary mediastinal B-cell lymphoma. Blood. 2018 Jul 12;132(2):179-186. doi: 10.1182/blood-2018-01-826958. Epub 2018 May 2.
citation: Ceriani L, Martelli M, Zinzani PL, Ferreri AJ, Botto B, Stelitano C, Gotti M, Cabras MG, Rigacci L, Gargantini L, Merli F, Pinotti G, Mannina D, Luminari S, Stathis A, Russo E, Cavalli F, Giovanella L, Johnson PW, Zucca E. Utility of baseline 18FDG-PET/CT functional parameters in defining prognosis of primary mediastinal (thymic) large B-cell lymphoma. Blood. 2015 Aug 20;126(8):950-6. doi: 10.1182/blood-2014-12-616474. Epub 2015 Jun 18.
citation: Martelli M, Ceriani L, Zucca E, Zinzani PL, Ferreri AJ, Vitolo U, Stelitano C, Brusamolino E, Cabras MG, Rigacci L, Balzarotti M, Salvi F, Montoto S, Lopez-Guillermo A, Finolezzi E, Pileri SA, Davies A, Cavalli F, Giovanella L, Johnson PW. [18F]fluorodeoxyglucose positron emission tomography predicts survival after chemoimmunotherapy for primary mediastinal large B-cell lymphoma: results of the International Extranodal Lymphoma Study Group IELSG-26 Study. J Clin Oncol. 2014 Jun 10;32(17):1769-75. doi: 10.1200/JCO.2013.51.7524. Epub 2014 May 5.