drugset / Trial / NCT00517699
A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-09
- Primary completion
- 2009-03
- Completion
- 2009-03
Outcome
Outcome not reported
Stopped (Enrollment): “Study was terminated early due to lack of enrollment.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 2 g | Intravenous |
| Subject | Methotrexate | Small molecule | 8 g | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 750 mg/m2 | Intravenous |