Lenalidomide in Treating Patients With High-Risk Chronic Lymphocytic Leukemia

Inclusion Criteria:

Definitive diagnosis of B-cell chronic lymphocytic leukemia (B-CLL) as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria

Must have high-risk B-CLL as defined by ≥ one of the following:

High-risk cytogenetics (either 17p deletion and/or 11q deletion)
Unmutated immunoglobulin heavy chain gene rearrangement
Zap-70 and CD38 expression on leukemic cells will not be used as eligibility criteria for enrollment into the clinical trial
No prior treatment for the management of B-CLL
Patients must have B-CLL requiring therapy as defined by the IWCLL criteria

Must have measurable disease meeting one of the following criteria:

Absolute lymphocyte count > 5,000/μL
Measurable lymphadenopathy or organomegaly

No tumor lysis syndrome (TLS) by Cairo-Bishop definition

Patients with correction of electrolyte abnormalities allowed
ECOG performance status 0-2
ANC ≥ 1,500/mm³
Platelet count ≥ 75,000/mm³
Creatinine clearance ≥ 30 mL/min
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST and ALT ≤ 3 times ULN (≤ 5 times ULN if hepatic metastases are present)

Uric acid normal

Patients with elevated uric acid allowed provided it is corrected with appropriate pharmacologic measures
Not pregnant or nursing
Negative pregnancy test
Fertile patients must commit to continued abstinence from heterosexual intercourse or use 2 acceptable methods of contraception (1 highly effective method and 1 additional effective method) ≥ 28 days prior to, during, and for ≥ 28 days after discontinuing lenalidomide
Able to adhere to the study visit schedule and other protocol requirements
No serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
No condition, including the presence of laboratory abnormalities, that would place the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
No known hypersensitivity to thalidomide or lenalidomide
No history of erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs
No history of any other cancer except non-melanoma skin cancer or carcinoma in-situ of the cervix or cancer for which the patient is in complete remission and off therapy for > 3 years
No cardiac arrest within the past 6 months
No known history of hepatitis B infection, positive hepatitis B surface antigen, or positive hepatitis C antibody
No other concurrent anti-cancer agents or treatments
More than 28 days since any prior experimental drug or therapy
Aspirin (81 or 325 mg) or warfarin sodium daily as prophylactic anticoagulation required
No prior lenalidomide