A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma
2 other identifiers
observational
125
4 countries
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2007
Longer than P75 for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 22, 2009
CompletedFirst Posted
Study publicly available on registry
July 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2017
CompletedAugust 15, 2017
August 1, 2017
4.3 years
July 22, 2009
August 11, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
response rate on PET scanning following initial chemo-immunotherapy
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
IRCCS Ospedale Oncologico
Bari, Italy
Policlinico S. Orsola Malpighi
Bologna, Italy
Ospedale Oncologico
Cagliari, Italy
Policlinico Careggi
Florence, Italy
A.O.Papardo
Messina, Italy
Ospedale Niguarda Ca' Granda
Milan, Italy
Ospedale San Raffaele
Milan, Italy
Università di Modena, Policlinico
Modena, Italy
Policlinico S. Matteo
Pavia, Italy
A.O. Bianchi-Melacrino-Morelli
Reggio Calabria, Italy
Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Università di Roma "La Sapienza" - DAI Ematologia
Rome, 00161, Italy
Humanitas
Rozzano, Italy
Ospedale Maggiore San Giovanni Battista
Torino, Italy
Ospedale di Circolo Fondazione Macchi
Varese, Italy
Clinic Hospital Universitari
Barcelona, Spain
IOSI
Bellinzona, 6500, Switzerland
Barts & the London NHS Trust
London, United Kingdom
Royal Marsden NHS Foundation Trust
London, United Kingdom
Related Publications (3)
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.
PMID: 29720487DERIVEDCeriani 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.
PMID: 26089397DERIVEDMartelli 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.
PMID: 24799481DERIVED
Biospecimen
tissue
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2009
First Posted
July 23, 2009
Study Start
January 1, 2007
Primary Completion
May 1, 2011
Study Completion
February 27, 2017
Last Updated
August 15, 2017
Record last verified: 2017-08