| Exclusion Criteria: | 1) Cancer radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or other investigational therapy within 4 weeks prior to Study Day 1
2) Previous exposure to lumiliximab or other anti-CD23 antibodies
3) Patients who have had a prior allogeneic BMT or autologous BMT or peripheral stem-cell transplant (PBSCT).
4) Known infection with HIV, hepatitis B, or hepatitis C
5) Uncontrolled diabetes mellitus
6) Uncontrolled hypertension
7) Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter's Syndrome, or prolymphocyte leukemia [PLL])
8) Patients with secondary malignancy requiring active treatment (except hormonal therapy)
9) Patients with medical conditions currently requiring long-term use (> 1 month) of systemic corticosteroids
10) Serious nonmalignant disease or laboratory abnormality, which, in the opinion of the investigator and/or sponsor, would compromise protocol objectives
11) Active uncontrolled bacterial, viral, or fungal infections
12) 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
13) Seizure disorders requiring anticonvulsant therapy
14) Severe chronic obstructive pulmonary disease with hypoxemia
15) Major surgery, other than diagnostic surgery, within 4 weeks prior to Study Day 1
16) Clinically active autoimmune disease
17) Patients with a history of fludarabine-induced autoimmune cytopenia
18) Pregnant or currently breast feeding
19) Patients who did not respond to prior FCR therapy (relapsed within 6 months of the last dose) |