orbital lymphoma MedDRA version: 9.1 Level: LLT Classification code 10003899 Term: B-cell lymphoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -primary diffuse large cell B cell Lymphoma / Follicular-centre cell lymphoma -expression of Antigen CD20 -ocular/periocular confined lesion 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: -other subtype of lymphomas than primary diffuse large cell B cell Lymphoma / Follicular-centre cell lymphoma -no expression of Ag CD20 -widespread diffusion of disease -age<18 -pregnancy -lactation -unstable cardiopathy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the safety and efficacy of intralesional administration of a anti-CD20 monoclonal antibody (rituximab) for the treatment of patients affected by lymphomas CD20+ limited to ocular and peri-ocular localization.;Secondary Objective: nd;Primary end point(s): nd | — |
Countries
Italy