Rituximab Versus Observation as Maintenance Therapy in Chronic Lymphocytic Leukemia (Chronic Lymphocytic Leukemia)

International, Multicentre, Randomized Phase III Study of Rituximab as Maintenance Treatment Versus Observation Alone in Patients With Chronic Lymphocytic Leukemia

The purpose of the study is to evaluate the ability of Rituximab maintenance therapy to prolong progression free survival in patients with chronic lymphocytic leukemia, who responded to a Rituximab induction therapy.

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