A Proof of Concept Study of the Safety, Tolerability and Efficacy of Avastin (Bevacizumab) in Patients With Chemonaive Chronic Lymphocytic Leukemia (CLL)

This single arm study will evaluate the bone marrow response, safety and tolerability of six months treatment with Avastin monotherapy in patients with chronic lymphocytic leukemia. Patients will receive 8 cycles (21 days duration) of Avastin monotherapy (15mg/kg) with 6 months of follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Inclusion Criteria:

• male or female patients, >=18 years of age;
• B-chronic lymphocytic leukemia not yet requiring treatment;
• ECOG performance status 0-2;
• no previous treatment of CLL by chemotherapy, radiotherapy or immunotherapy;
• life expectancy >6 months.

Exclusion Criteria:

• CNS involvement by lymphoma or any evidence of spinal cord compression;
• CT scan based evidence of tumor invading major blood vessels;
• GI tract involvement by CLL;
• active viral, bacterial or fungal infection;
• uncontrolled hypertension, CVA/stroke (<=6 months prior to randomization), myocardial infarction (<=6 months prior to randomization), unstable angina (>=NYHA Grade IV), thrombosis within 6 months before enrollment, NYHA Grade II CHF or serious cardiac arrhythmia requiring ongoing medication.