A Clinico-Pathologic Study of Primary Mediastinal B-Cell Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
International Extranodal Lymphoma Study Group (IELSG)
Information provided by:
International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier:
NCT00944567
First received: July 22, 2009
Last updated: April 4, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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):
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), 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: | April 4, 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 May 21, 2013