Newly diagnosed Primary Central Nervous Lymphoma MedDRA version: 8.1 Level: PT Classification code 10007953 Term: Central nervous system lymphoma
Conditions
Interventions
Trade Name: Methotrexate
Product Name: Methotrexate
Pharmaceutical Form: Intravenous infusion
Trade Name: ifosfamide
Product Name: Ifosfamide
Pharmaceutical Form: Intravenous infusion
Trade Name: Cy
Sponsors
Nordic Lymphoma Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria Pathologically verified primary central nervous system lymphoma No prior PCNSL treatment. Patients treated with steroids alone are eligible No signs of lymhpoma outside the CNS ECOG performance status 0-4 (Appendix 1) Age > 18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria Cardiac failure > 3 (NYHA , Appendix 2) Pregnancy or lactation Previous malignancy unless diseasefree for at least five years Active infection Positive HIV status Organ transplantation Serious psychiatric illness Prior radiotherapy to the brain 5.2.9 Concomitant anti-inflammatory medication that cannot be discontinued 5.2.10 Creatinine clearance 1.5 times or ASAT and alkaline phosphatase >2 times upper limits of normal. 5.2.13 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 ;Secondary Objective: ;Primary end point(s): After completion of the induction therapy: Primary end-point: overall survival Secondary end-points: response rate systemic toxicity based on Common Toxicity Criteria neurotoxicity evaluted by MMSE and FIM After completion of all therapy: Primary end-points: overall survival neurotoxicity evaluated by MMSE and FIM Secondary end-points: time to treatment failure time to progression | — |
Countries
Denmark, Finland, Sweden
Outcome results
None listed