Trial information
A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma.
Status: Recruiting
Protocol number: ML19652
Company division: Pharmaceutical
Official Scientific Title: An open label study of the effect of Rituxan, high dose methotrexate and high dose cytarabine on response rate in patients with primary central nervous system lymphoma.
Brief summary: This single arm 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 i.v.) plus methotrexate (8g/m2) given at intervals up to week 22, plus cytarabine (2g/m2 i.v.) at week 11 and week 22. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Study phase: II
Study type: Interventional; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Lymphomas
Intervention type: Drug
Intervention name: rituximab [MabThera/Rituxan]
Primary outcome: Complete response rate; overall response rate. Timeframe: Event driven.
Key secondary outcomes: Relapse rate, overall survival, progression-free survival. Timeframe: Event driven.
AEs, laboratory parameters. Timeframe: Throughout study.
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: July, 2007
Trial registration date: 08/08/2007
Date last updated: 10/15/2008
Link to trial result
This trial is being conducted at the following locations:
Canada
- Greenfield Park, QC
- Quebec City, QC
