Inclusion criteria | 1.Immunocompetent patients with newly-diagnosed primary central nervous system B-cell lymphoma 2.Age 18–65 years irrespective of ECOG or 66–70 years (with ECOG Performance Status ≤2) 3.Histologically or cytologically assessed diagnosis of B-cell lymphoma by local pathologist. 4.Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy 5.Disease exclusively located in the CNS 6.At least one measurable lesion 7.Previously untreated patients (previous or ongoing steroid treatment admitted) 8.Sexually active patients of childbearing potential who agree to take adequate contraceptive measures during study participation 9.Written informed consent obtained according to international guidelines and local laws by patient or authorized legal representative in case patient is temporarily legally not competent due to his or her disease |
Additional randomization criteria | 1.Sufficient stem cell harvest (≥ 5 x 106 CD34+ cells/kg of body weight) 2.Complete remission, unconfirmed complete remission or partial remission 3.Central pathology results confirming local results |
Exclusion criteria | 1.Congenital or acquired immunodeficiency 2.Systemic lymphoma manifestation (outside the CNS) 3.Isolated ocular lymphoma without manifestation in the brain parenchyma or spinal cord 4.Previous or concurrent malignancies with the exception of surgically cured carcinoma insitu of the cervix, carcinoma of the skin or other kinds of cancer without evidence of disease for at least 5 years 5.Previous Non-Hodgkin lymphoma at any time 6.Inadequate bone marrow (platelet count decreased ≥ CTC grade 1, anemia ≥ CTC grade 1, neutrophil count decreased ≥ CTC grade 1), renal (creatinine clearance <60 ml/min), cardiac (ejection fraction decreased ≥ CTC grade 2), or hepatic function (blood bilirubin increased ≥ CTC grade 2, alanine aminotransferase increased ≥ CTC grade 2, aspartate aminotransferase increased ≥ CTC grade 2 or gamma-GT increased ≥ CTC grade 2) 7.HBsAg, anti-HBc or HCV positivity 8.HIV infection, previous organ transplantation or other clinical evident form of immunodeficiency 9.Concurrent treatment with other experimental drugs or participation in a clinical trial within the last thirty days before the start of this study 10.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) 11.Severe non-compensated pulmonary disease (IVC <55 %, DLCO <40 %) 12.Third space fluid accumulation >500 ml 13.Hypersensitivity to study treatment or any component of the formulation 14.Taking any medications likely to cause interactions with the study medication 15.Known or persistent abuse of medication, drugs or alcohol 16.Patient without legal capacity and who is unable to understand the nature, significance and consequences of the study and without designated legal representative 17.Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator 18.Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 19.Concurrent (or planned) pregnancy or lactation 20.Fertile patients refusing to use safe contraceptive methods during the study |