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

Primary Mediastinal B-Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944567
• Other study ID #: IELSG26
• Secondary ID: EudraCT number 2
• Status: Completed
• Phase: N/A
• First received: July 22, 2009
• Last updated: August 11, 2017
• Start date: January 2007
• Est. completion date: February 27, 2017

Study information

• Verified date: August 2017
• Source: International Extranodal Lymphoma Study Group (IELSG)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: February 27, 2017
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Primary Mediastinal B-Cell Lymphoma

Locations

Country	Name	City	State
Italy	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	Firenze
Italy	A.O.Papardo	Messina
Italy	Ospedale Niguarda Ca' Granda	Milano
Italy	Ospedale San Raffaele	Milano
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
Italy	Humanitas	Rozzano
Italy	Ospedale Maggiore San Giovanni Battista	Torino
Italy	Ospedale di Circolo Fondazione Macchi	Varese
Spain	Clinic Hospital Universitari	Barcelona
Switzerland	IOSI	Bellinzona
United Kingdom	Barts & the London NHS Trust	London
United Kingdom	Royal Marsden NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
International Extranodal Lymphoma Study Group (IELSG)

Countries where clinical trial is conducted

Italy,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate on PET scanning following initial chemo-immunotherapy