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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier:
NCT00944567
First received: July 22, 2009
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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.


Condition
Primary Mediastinal B-Cell Lymphoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by International Extranodal Lymphoma Study Group (IELSG):

Primary Outcome Measures:
  • response rate on PET scanning following initial chemo-immunotherapy

Biospecimen Description:

tissue


Enrollment: 125
Study Start Date: January 2007
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944567

Locations
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 San Raffaele
Milano, Italy
Ospedale Niguarda Ca' Granda
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, 00161
Humanitas
Rozzano, Italy
Ospedale Maggiore San Giovanni Battista
Torino, Italy
Ospedale di Circolo Fondazione Macchi
Varese, Italy
Spain
Clinic Hospital Universitari
Barcelona, Spain
Switzerland
IOSI
Bellinzona, Switzerland, 6500
United Kingdom
Royal Marsden NHS Foundation Trust
London, United Kingdom
Barts & the London NHS Trust
London, United Kingdom
Sponsors and Collaborators
International Extranodal Lymphoma Study Group (IELSG)
  More Information

No publications provided

Responsible Party: International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier: NCT00944567     History of Changes
Other Study ID Numbers: IELSG26, EudraCT number 2006-005794-22
Study First Received: July 22, 2009
Last Updated: November 5, 2013
Health Authority: Switzerland: Swissmedic
United Kingdom: Research Ethics Committee
Italy: Ethics Committee

Keywords provided by International Extranodal Lymphoma Study Group (IELSG):
Primary Mediastinal B-Cell Lymphoma
Positron emission tomography

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on April 15, 2014