Inclusion criteria
- Patients with a histologically confirmed diagnosis of CD20 positive DLBCL based upon a representative histology specimen of brain biopsy according to the WHO classification (see appendix A):
OR
Patients with a diagnosis of PCNSL based on MRI evidence of brain parenchymal lesion showing homogeneous contrast enhancement suspect for lymphoma
AND
Unequivocal morphological and/or immunophenotypical evidence of CSF
CD20 + large cell lymphoma
AND/OR Unequivocal morphological and/or immunophenotypical evidence of CD20 + large cell lymphoma in vitreous fluid
OR
Patients with unequivocal morphological and/or immunophenotypical evidence of CD20 + large cell lymphoma in vitreous fluid AND CSF but without a brain parenchymal lesion - Age 18-70 years inclusive
- Performance status with or without administration of steroids WHO/ECOG 0-3 (see appendix D)
- Written informed consent
Exclusion criteria
- Evidence of systemic lymphoma
- History of intolerance of exogenous protein administration
- Severe cardiac dysfunction (NYHA classification III-IV, appendix G, or LVEF < 45%) Congestive heart failure or symptomatic coronary artery disease or cardiac arythmias not well controlled with medication
- Severe pulmonary dysfunction (vital capacity or diffusion capacity < 50% of predicted value)
- Significant hepatic dysfunction (bilirubin or transaminase >= 2.5 x upper normal limit) at Screening.
- Significant renal dysfunction (serum creatinine >= 150 micro?mol/l or clearance < 60 ml/min) at Screening
- Presence of ’third space fluid’, such as pleural effusion or ascites
- Prior cranial radiotherapy
- Active uncontrolled infection
- HIV-positivity
- (EBV positive) post-transplant lymphoproliferative disorder
- Untreated hepatitis B infection (inclusion is possible if adequate antiviral medication e.g. lamivudine or alternative is started and continued for the duration of the trial)
- Positive pregnancy test in women of reproductive potential
- Lactating women
- Unable or unwilling to use adequate contraceptive methods (all men, pre-menopausal women) until 12 months after last chemotherapy treatment
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
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