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

Inclusion Criteria:

* Age: 18 years and older
* Diagnosis of B-cell CLL by International Workshop on CLL (IWCLL) response criteria
* Relapsed CD23+ B-cell CLL
* Rai Stage III or IV, or Rai Stage I or II if determined to have disease progression as evidenced by rapid doubling or peripheral lymphocyte count, progressive lymphadenopathy, progressive splenomegaly, or B symptoms
* Prestudy WHO Performance Status less than or equal to 2
* Signed, written Institutional Review Board (IRB)-approved informed consent
* Men \& women of reproductive potential must agree to follow accepted birth control methods during treatment for 3 months after completion of treatment
* Acceptable liver function: Bilirubin less than or equal to 2.0 mg/dL (26 µmol/L), AST (SGOT) \&/or ALT (SGPT) less than or equal to 2 times upper limit of normal
* Acceptable hematologic status: Platelet count less than or equal to 50 x 10\^9/L, ANC less than or equal to 1 x 109/L
* Acceptable renal function: Serum creatinine less than or equal to 1.5 times upper limit of normal

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