Lenalidomide Dose Escalation Combined With Rituximab/Fludarabine in Untreated CLL

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to determine the maximal tolerated dose level of lenalidomide combined with fludarabine/rituximab in the therapy of patients with previously untreated CD20-positive chronic lymphocytic leukemia. Following a dose escalation phase lenalidomide will be given at the pre-determined maximum tolerated dose in combination with rituximab to further determine the efficacy and tolerability of this regimen.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Collaborators: Celgene Corporation; Roche Pharma AG
• Treatments: Fludarabine; Fludarabine phosphate; Lenalidomide; Rituximab; Thalidomide; Vidarabine

Criteria

Inclusion Criteria:

• B-CLL (CD23+, CD5+, CD19+, CD20+)

• Treatment indication according to NCI criteria

• Age >= 18 yrs

• No previous treatment of CLL by chemo-, radio- or immunotherapy

• Life expectancy > 6 months

• Written informed consent

• Women of non-childbearing potential or women of childbearing potential and men using effective contraception

Exclusion Criteria:

• Active bacterial, viral or fungal infection

• Positivity for HIV, Hepatitis B or C

• Reduce organ functions and bone marrow dysfunction not due to CLL

• Creatinine clearance below 30 ml/min

• Patients with medical conditions requiring long-term use of systemic corticosteroids during study treatment

• Patients with a history of severe cardiac disease

• Other known co-morbidity with the potential to dominate survival

• Transformation to aggressive B-cell malignancy

• Known hypersensitivity to humanised monoclonal antibodies or any of the study drugs

• Pregnant or breast-feeding women

• Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent