A Pilot Study of Lenalidomide as a Chemopreventive Agent for Patients With High-Risk, Early Stage B-Chronic Lymphocytic Leukemia (CLL)

Inclusion Criteria:

- Must have a definitive diagnosis of B-CLL

- Must have early stage B-CLL Rai stage 0, 1, or 2

- Must not have received any prior treatment for management of B-CLL

- Must be assessed to have high risk B-CLL as defined by either one of the following
criterion:

- High-risk cytogenetics (either 17p deletion or 11 q deletion)

- Unmutated immunoglobulin heavy chain gene rearrangement

- Must understand and voluntarily sign an informed consent form

- Must be ≥ to 18 years of age

- Able to adhere to the study visit schedule or other protocol requirements

- Must have measurable disease with an absolute lymphocytic counts of > 5,000/µL or
measurable lymphadenopathy or organomegaly

- ECOG ≤ 2 at study entry

- Females must have negative pregnancy test

- Able to take aspirin (81 or 325mg) or warfarin sodium daily as prophylactic
anticoagulation.

- Laboratory test results within these ranges:

- Absolute neutrophil count ≥ 1.0 x 10 9/L

- Platelet count ≥ 30 x 10 9/L

- Serum creatinine < 1.5 x ULN.

- Total bilirubin < 1.5 mg/dL

- AST (SGOT) and ALT (SGPT) ≤ 2 x ULN or ≤ 5 x ULN if hepatic metastases are
present.

Exclusion Criteria:

- Any serious medical condition, laboratory abnormality or psychiatric illness that
would prevent the subject from signing the informed consent

- Pregnant or lactating females

- Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.

- Use of any other experimental drug or therapy within 28 days of baseline

- Known hypersensitivity to thalidomide or lenalidomide

- Prior history of development of erythema nodosum if characterized by a desquamating
rash while taking thalidomide or similar drugs.

- Patients who have been treated with any prior therapy for B-CLL

- Patients with history of any other cancer

- Patients with history of cardiac arrest within the past 6 months

- Any prior use of lenalidomide

- Concurrent use of other anti-cancer agents or treatments

- History of hepatitis B or C

- Known HIV positive status