A Phase I/II Study of Lumiliximab in Combination With Fludarabine, Cyclophosphamide, and Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia

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