Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma

The objective of the study is

• To investigate the efficacy and safety of a high-dose methotrexate-based induction polychemotherapy regimen combined with Rituximab and intraspinal DepoCyte followed by temozolomide maintenance treatment in newly diagnosed primary central nervous system lymphoma
• To assess the long term outcome concerning neurotoxicity

Inclusion criteria

• Pathologically verified primary central nervous system lymphoma No prior PCNSL treatment.
• Patients treated with steroids alone are eligible
• No signs of lymphoma outside the CNS
• ECOG performance status 0-4
• Age > 17 and < 76 years
• Written informed consent from the patient or guardian

Exclusion criteria

• Cardiac failure > 3
• Pregnancy or lactation. Women of childbearing potential are requested to use an effective method of contraception to avoid pregnancy for a period from entry to the study and at least 3 months after the last study medication
• Previous malignancy unless disease free for at least five years
• Active infection.
• Regarding tuberculosis, patients at risk should be tested for latent TB according local practice at each treating centre.
• Positive HIV status
• Organ transplantation
• Serious psychiatric illness
• Prior radiotherapy to the brain
• Concomitant anti-inflammatory medication that cannot be discontinued
• Creatinine clearance < 60 ml/minute calculated by Cockcroft and Gault formula
• Peripheral blood count with granulocytes <1.5 x 109L or platelets < 100 x 109L
• Serum bilirubin >1.5 times or ASAT and alkaline phosphatase >2 times upper limits of normal.
• Known anaphylaxis or IgE-mediated hypersensitivity to murine protein or any component of Rituximab excludes patients from Rituximab treatment, but not from the remaining part of the study