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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 November 2012
• Main ID: NCT01458730
• Date of registration: 15/09/2011
• Primary sponsor: University of Aarhus
• Public title: Nordic Study in Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
• Scientific title: Immunochemotherapy in Primary Central Nervous System Lymphoma With Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Ifosfamide, Vincristine, Vindesine, Temozolomide and DepoCyte Induction Followed by Maintenance Treatment in Elderly Patients With Temozolomide.
• Date of first enrolment: May 2007
• Target sample size: 66
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01458730
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Denmark

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Central Nervous System Lymphoma

Intervention(s)

Drug: Immunochemotherapy

Primary Outcome(s)

Overall survival

Secondary Outcome(s)

neurotoxicity [Time Frame: 1-10 years after completion of therapy]

response rate [Time Frame: at completion of therapy]

Secondary ID(s)

EudraCT No 2006-004772-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Mundipharma

Nordic Cancer Union

Roche Pharma AG

Schering-Plough