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
- ewly diagnosed Primary Central Nervous Lymphoma
- Registration Number
- EUCTR2006-004772-12-SE
- Lead Sponsor
- ordic Lymphoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 70
1 Pathologically verified primary central nervous system lymphoma
2 No prior PCNSL treatment. Patients treated with steroids alone are eligible
3 No signs of lymhpoma outside the CNS
4 ECOG performance status 0-4
5 Age > 18 and < 75 years
6 Written informed consent from the patient or guardi
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1 Cardiac failure > 3 (NYHA , Appendix 2)
2 Pregnancy or lactation
3 Previous malignancy unless diseasefree for at least five years
4 Active infection
5 Positive HIV status
6 Organ transplantation
7 Serious psychiatric illness
8 Prior radiotherapy to the brain
9 Concomitant anti-inflammatory medication that cannot be discontinued
10 Creatinine clearance < 60 ml/minute calculated by Cockcroft and Gault formula
11 Peripheral blood count with granulocytes <1.5 x 109L or platelets < 100 x 109L
12 Serum bilirubin >1.5 times or ASAT and alkaline phosphatase >2 times upper
limits of normal.
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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;Secondary Objective: To assess the long term outcome concerning neurotoxicity<br>;Primary end point(s): After completion of the induction therapy: <br>1 Primary end-point:overall survival <br>2 Secondary end-points:response rate <br> neurotoxicity evaluted by MMSE and FIM<br><br>After completion of all therapy: <br>3 Primary end-points: overall survival<br> neurotoxicity evaluated by MMSE and FIM <br>4 Secondary end-points: time to treatment failure<br> time to progression<br><br>
- Secondary Outcome Measures
Name Time Method