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

Roche

Status and phase

Terminated

Phase 2

Conditions

Lymphoma

Treatments

Drug: Methotrexate

Drug: Cytarabine

Drug: rituximab [MabThera/Rituxan]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00517699

ML19652

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.