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. MedDRA version: 6.1 Level: PT Classification code 10036710
Conditions
Interventions
Trade Name: MABTHERA*EV 1FL 50ML 500MG
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
IELSG (INTERNATIONAL EXTRANODAL LYMPHOMA STUDY GROUP)
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Systematically to analyse the phenotype and molecular characteristics of Primary Mediastinal Large B-cell Lymphoma 2. To determine the PET response rate following chemo-immunotherapy;Secondary Objective: To obtain data, on a non-randomised basis, regarding the outcomes of treatment using different chemotherapy regimens, and using or omitting mediastinal radiotherapy depending upon the practice of the participating institutions. 2. Progression free and overall survival will be analysed.;Primary end point(s): This will be the response rate on PET scanning following initial chemo-immunotherapy. | — |
Countries
Italy
Outcome results
None listed