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.

Phase 1

• Conditions: ewly diagnosed Primary Central Nervous Lymphoma; MedDRA version: 8.1Level: PTClassification code 10007953Term: Central nervous system lymphoma

• Registration Number: EUCTR2006-004772-12-DK
• Lead Sponsor: ordic Lymphoma Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-01
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

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 < 75 years
Written informed consent from the patient or guardian
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

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 < 60 ml/minute calculated by Cockcroft and Gault formula
(Appendix 4)
5.2.11 Peripheral blood count with granulocytes <1.5 x 109L or platelets < 100 x 109L
5.2.12 Serum bilirubin >1.5 times or ASAT and alkaline phosphatase >2 times upper limits
of normal.
5.2.13Known 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