Lumiliximab in Combination With FCR in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL)

Exclusion Criteria

• •Subjects who did not respond to prior FCR therapy (relapsed within 6 months of the last dose).
• •Cancer radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or other investigational therapy within 4 weeks prior to Study Day 1
• •Previous exposure to lumiliximab or other anti-CD23 antibodies
• •Subjects who have had a prior allogenic bone marrow transplant (BMT) or autologous BMT or peripheral stem-cell transplant (PBSCT)
• •Known infection with HIV, hepatitis B, or hepatitis C
• •Uncontrolled diabetes mellitus
• •Uncontrolled hypertension
• •Transformation to aggressive B-cell malignancy (e.g., larger B-cell lymphoma, Richter's Syndrome, or prolymphocyte leukemia (PLL)
• •Subjects with secondary malignancy requiring active treatment (except hormonal therapy)
• •Subjects with medical conditions currently requiring long-term use (less than 1 month) of systemic corticosteroids
• •Serious nonmalignant disease or laboratory abnormality, which, in the opinion of the investigator \&/or sponsor, would compromise protocol objectives
• •Active uncontrolled bacteria, viral, or fungal infections
• •New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months prior to Study Day 1, unstable arrhythmia, or evidence of ischemia on ECG within 14 days prior to Study Day 1
• •Seizure disorders requiring anticonvulsant therapy
• •Severe chronic obstructive pulmonary disease with hypoxemia
• •Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1
• •Clinically active autoimmune disease
• •Subjects with a history of fludarabine-induced autoimmune cytopenia
• •Pregnant or currently breast-feeding