International, Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Chronic Lymphocytic Leukemia
Inclusion Criteria:
- B-CLL
- Age >18
- ECOG performance status 0-2
- Previous Rituximab containing induction treatment of the CLL in 1st or 2nd line
- Patient must be in complete remission or partial remission after an induction
treatment containing rituximab
- ANC (absolute neutrophil count) > 1,0 x 10e9 /L
- Life expectancy > 6 months
- Patient´s written informed consent
- Patient using a reliable means of contraception for the duration of the treatment
including 2 months thereafter
Exclusion Criteria:
- Active uncontrolled bacterial, viral or fungal infection
- Significantly reduced organ functions and bone marrow dysfunction not due to CLL
- creatinine clearance of below 30mL/min
- Patients with a history of other malignancies within 2 years prior to study entry
- Patients with a history of severe cardiac disease
- Other known comorbidity with the potential to dominate survival
- Transformation to aggressive B-cell malignancy
- Hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any
of the applied drugs
- Medical condition requiring prolonged (> 1 month) use of oral corticosteroids
- Pregnant or breast feeding women
- Any coexisting medical or psychological condition that would preclude participation
in the study or compromise ability to give informed consent