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

University of Aarhus

Status and phase: Completed; Phase 2

Conditions: Central Nervous System Lymphoma

Treatments: Drug: Immunochemotherapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01458730

EudraCT No 2006-004772-12

Details and patient eligibility

About

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.

Full description

The objective of the study is

1. 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
2. To assess the long term outcome concerning neurotoxicity

Enrollment: 66 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)