Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete response rate;overall response rate
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Canada: Health Canada
Study ID:
ML19652
NCT ID:
NCT00517699
Start Date:
September 2007
Completion Date:
March 2009
Related Keywords: