A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma

Completed

• Conditions: Primary Mediastinal B-Cell Lymphoma

• Registration Number: NCT00944567
• Lead Sponsor: International Extranodal Lymphoma Study Group (IELSG)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2009-07-22
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Primary Completion: 2011-05
• Study Completion: 2017-02-27
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-11
• Last Update Posted: 2017-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
response rate on PET scanning following initial chemo-immunotherapy

Trial Locations

Locations (20)

Ospedale Oncologico; 🇮🇹 Cagliari, Italy

Policlinico Careggi; 🇮🇹 Firenze, Italy

A.O.Papardo; 🇮🇹 Messina, Italy

Università di Modena, Policlinico; 🇮🇹 Modena, Italy

Ospedale di Circolo Fondazione Macchi; 🇮🇹 Varese, Italy

Policlinico S. Matteo; 🇮🇹 Pavia, Italy

IOSI; 🇨🇭 Bellinzona, Switzerland

A.O. SS. Antonio e Biagio e Cesare Arrigo; 🇮🇹 Alessandria, Italy

Università di Roma "La Sapienza" - DAI Ematologia; 🇮🇹 Rome, Italy

Ospedale Maggiore San Giovanni Battista; 🇮🇹 Torino, Italy

Ospedale Niguarda Ca' Granda; 🇮🇹 Milano, Italy

A.O. Bianchi-Melacrino-Morelli; 🇮🇹 Reggio Calabria, Italy

Arcispedale S. Maria Nuova; 🇮🇹 Reggio Emilia, Italy

IRCCS Ospedale Oncologico; 🇮🇹 Bari, Italy

Policlinico S. Orsola Malpighi; 🇮🇹 Bologna, Italy

Ospedale San Raffaele; 🇮🇹 Milano, Italy

Clinic Hospital Universitari; 🇪🇸 Barcelona, Spain

Humanitas; 🇮🇹 Rozzano, Italy

Barts & the London NHS Trust; 🇬🇧 London, United Kingdom

Royal Marsden NHS Foundation Trust; 🇬🇧 London, United Kingdom