Randomized Phase II Trial On Primary Chemotherapy With High-Dose Methotrexate And High-Dose Cytarabine With Or Without Thiotepa, And With Or Without Rituximab, Followed By Brain Irradiation Vs. High-Dose Chemotherapy Supported By Autologous Stem Cells Transplantation For Immunocompetent Patients With Newly Diagnosed Primary CNS Lymphoma
- Histological or cytological assessed diagnosis of non-Hodgkin's lymphoma.
- Diagnostic sample obtained by stereotactic or surgical biopsy, Cerebrospinal Fluid
(CSF) cytology examination or vitrectomy.
- Disease exclusively localized into the central nervous system, CSF, cranial nerves or
- At least one measurable lesion.
- Previously untreated patients (previous or ongoing steroid therapy admitted).
- Age 18-65 years (with ECOG Performance Status 0-3) or 66-70 (with ECOG Performance
- Adequate bone marrow, renal, cardiac, and hepatic function.
- Sexually active patients of childbearing potential agreeing in implementing adequate
contraceptive measures during study participation.
- Absence of any familial, sociological or geographical condition potentially hampering
compliance with the study protocol and follow-up schedule.
- Patient-signed informed consent obtained before registration.
- Patients with lymphomatous lesions outside the CNS.
- Patients with a previous non-Hodgkin lymphoma at any time.
- Previous or concurrent malignancies with the exception of surgically cured carcinoma
in-situ of the cervix, carcinoma of the skin or other cancers without evidence of
disease at least from 5 years.
- HBsAg and HCV positivity.
- HIV infection, previous organ transplantation or other clinically evident form of
- Concurrent treatment with other experimental drugs.
- Concurrent Pregnancy or lactation.
- Patients not agreeing to take adequate contraceptive measures during the study.
- Symptomatic coronary artery disease, cardiac arrhythmias uncontrolled with medication
or myocardial infarction within the last 6 months (New York Heart Association Class
III or IV heart disease).