Trial Information
An Open-label Study of Fludarabine and Cyclophosphamide Plus MabThera Followed by Maintenance With MabThera on Failure-free Survival in Treatment-naïve Patients With Advanced Indolent B-cell Nonfollicular Lymphoma
Inclusion Criteria:
- adult patients 18-65 years of age;
- previously untreated indolent nonfollicular non-Hodgkin's lymphoma;
- active disease;
- >=3 involved sites.
Exclusion Criteria:
- typical chronic lymphocytic leukemia;
- other malignancies within 3 years before study, except basal or squamous cell skin
cancer or cancer in situ of the cervix;
- systemic corticosteroid use for >1 month;
- significant cardiovascular disease;
- central nervous system involvement;
- hepatitis B or C virus infection, or HIV 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:
Failure-free survival
Outcome Time Frame:
From first patient enrolled to approximately 42 months
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Chair
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Italy: Ministry of Health
Study ID:
ML18324
NCT ID:
NCT01153971
Start Date:
July 2005
Completion Date:
September 2010
Related Keywords:
- Non-Hodgkin's Lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin