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

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Collaborator: Roche Pharma AG
• Treatments: Rituximab

Criteria

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