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