Overview

A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.

Status:
Terminated

Trial end date:
2009-03-01

Target enrollment:
0

Participant gender:
All

Summary

This study will evaluate the efficacy and safety of MabThera plus high dose methotrexate plus high dose cytarabine in patients with central nervous system non-Hodgkin's lymphoma. Eligible patients will receive a treatment regimen consisting of MabThera (750mg/m2 iv) plus methotrexate (8g/m2 iv) given at intervals up to week 22, plus cytarabine (2g/m2 iv) at week 11 and week 22. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Hoffmann-La Roche

Treatments:

Cytarabine
Methotrexate
Rituximab

Criteria

Inclusion Criteria:

- adult patients, 18-80 years of age;

- histological diagnosis of primary central nervous system lymphoma;

- B-cell proliferation verified by positive staining for CD20;

- >=1 measurable lesion.

Exclusion Criteria:

- prior chemotherapy, other than corticosteroids, >=6 weeks before and after diagnosis
or surgery;

- history of prior cranial irradiation;

- evidence of plurisystemic non-Hodgkin's lymphoma;

- other active malignant disease (other than basal cell or squamous cell cancer of
skin,or cancer in situ of cervix;

- uncontrolled active infection.