PATIENTS WITH SYSTEMIC B-CELL LYMPHOMA WITH CENTRAL NERVOUS SYSTEM INVOLVEMENT AT DIAGNOSIS OR RELAPSE MedDRA version: 9.1 Level: LLT Classification code 10003899 Term: B-cell lymphoma
Conditions
Interventions
Trade Name: MABTHERA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Rituximab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: ME
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of diffuse large-cell, follicular or mantle cell lymphoma 2. CNS involvement (brain, meninges, cranial nerves, eyes and/or spinal cord) at diagnosis or relapse after conventional chemotherapy 3. Diagnosis of CNS involvement either by brain biopsy or CSF cytology examination; neuroimaging alone is acceptable only when stereotactic biopsy is formally contraindicated 4. Age 19-65 years 5. ECOG performance status 0-3 6. Adequate bone marrow (PLT ?100000 mm3, Hb ?9 gr/dL, ANC ?2000 mm3), renal (creatinine clearance ?60 mL/min), cardiac (VEF > 50%), and hepatic function (total serum bilirubin =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: age under 19 and over 65; pregnancy and breast feeding; patients under treatment with sperimental drugs;..
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 2-year event-free survival;Secondary Objective: 1.response duration and overall survival 2.complete remission rate 3.tolerability 4.neurotoxicity;Primary end point(s): 2-year event-free survival | — |
Countries
Italy
Outcome results
None listed