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

Study Overview
=================
Brief 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.

Detailed Description
-----------------
The objective of the study is 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 To assess the long term outcome concerning neurotoxicity

Official 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.

Conditions
-----------------
Central Nervous System Lymphoma

Intervention / Treatment
-----------------
* Drug: Immunochemotherapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Immunochemotherapy|Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Iphosphamide, Vincristin, Vindesin, Temozolomide, Depocyte|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate |  | at completion of therapy | 
| neurotoxicity |  | 1-10 years after completion of therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCNSL, Immunochemotherapy, Intraspinal Depocyt, Maintenance temozolomide