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Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
CompletedPhase 2
Sponsor: University of Aarhus
Conditions: Central Nervous System Lymphoma
Interventions: Immunochemotherapy
Countries: Denmark
The purpose of the study is to test the efficacy and tolerability of a multiagent chemotherapy treatment regimen without radiotherapy in patients with newly diagnosed lymphoma in the brain.
Eligibility overview
Sex: ALL
Age: 18 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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
Locations (1)
- Aarhus, Denmark