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

• Status: Unknown status
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborators: Mundipharma Pte Ltd.; Nordic Cancer Union; Roche Pharma AG; Schering-Plough
• Treatments: Cyclophosphamide; Ifosfamide; Temozolomide

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