High grade B cell non-Hodgkin lymphoma. MedDRA version: 9.1 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell
Conditions
Interventions
Trade Name: ZEVALIN
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Ibritumomab tiuxetan(90Y)
Concentration unit: mCi/kg millicurie(s)/kilogram
Concentration type: equal
Concentration
Sponsors
AZIENDA OSPEDALIERA OSPEDALE S. SALVATORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of CD 20 positive B cell non-Hodgkin lymphoma. Age > 60 years. IPI>1. Stage > II. HIV negativity. Signed informed consent. 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: Age < 60 years. HIV positivity; Intercurrent organ damage or medical conditions which possibly would interfere with therapy. Concurrent infection not controlled by medical therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the 3-years event free survival;Secondary Objective: To evaluate the cumulative response rate. to evaluate the efficacy of Zevalin for the improvement of the response. To evaluate the disease free survival. to evaluate the overall survival. TO evaluate the early and late toxicity of the Zevalin therapy.;Primary end point(s): to evaluate the 3-years event free survival | — |
Countries
Italy
Outcome results
None listed