An Open Label Study to Assess the Effect of First Line Treatment With MabThera in Combination With Fludarabine and Cyclophosphamide, Followed by MabThera Monotherapy, on Response Rate in Patients With Chronic Lymphocytic Leukemia.
- adult patients, 18-70 years of age;
- CD20-positive B-cell chronic lymphocytic leukemia;
- active disease;
- no previous treatment.
- transformation to aggressive B-cell malignancy;
- history of other malignancies except for localised skin cancer;
- continuous systemic corticosteroid treatment;
- known infection with hepatitis B or C.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate, and percentage of patients with molecular remission
Outcome Time Frame:
Spain: Agencia Espanola del Medicamento y Productos Sanitarios
- Lymphocytic Leukemia, Chronic
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid
- Chronic Disease