Phase II Trial of Pentostatin, Cyclophosphamide, and Rituximab Followed by Consolidation With Lenalidomide for Previously Untreated B-Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL),
meeting the following criteria:

- Biopsy-proven SLL according to WHO criteria

- CLL diagnosis* according to NCI working group criteria as evidenced by all of
the following:

- Peripheral blood lymphocyte count of > 5,000/mm³

- Small to moderate peripheral blood lymphocyte with < 55% prolymphocytes

- Immunophenotyping consistent with CLL defined as:

- B-cell markers with CD5 antigen in the absence of other pan-T-cell
markers (e.g., CD3, CD2)

- CD19, CD20, or CD23

- Dim surface immunoglobulin expression

- Exclusively kappa or lambda light chains

- Diagnosis of mantle cell lymphoma must be excluded by negative FISH
analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy or
negative immunohistochemical stains for cyclin D1 on involved tissue biopsy
NOTE: *Splenomegaly, hepatomegaly, or lymphadenopathy are not required for
the diagnosis of CLL

- Previously untreated disease and meets ≥ 1 of the following criteria*:

- At least 1 or more of the following disease-related symptoms:

- Weight loss > 10% within the previous 6 months

- Extreme fatigue attributed to CLL

- Fevers > 100.5º F for 2 weeks without evidence of infection

- Night sweats without evidence of infection

- Evidence of progressive marrow failure as manifested by the development of or
worsening anemia (i.e., hemoglobin ≤ 11 g/dL) and/or thrombocytopenia (i.e.,
platelet count ≤ 100,000/mm³) not due to autoimmune disease

- Symptomatic or progressive lymphadenopathy, splenomegaly, or hepatomegaly

- Progressive lymphocytosis due to CLL with an increase of > 50% over a 2-month
period or an anticipated doubling time < 6 months NOTE: *Marked
hypogammaglobulinemia or the development of a monoclonal protein in the absence
of any of the above criteria for active disease are not sufficient for protocol
therapy

PATIENT CHARACTERISTICS:

- ECOG performance status 0-3

- Serum creatinine ≤ 1.5 times upper limit of normal (ULN)

- Total bilirubin ≤ 3.0 times ULN (unless due to Gilbert disease)

- Direct bilirubin < 1.5 mg/dL for Gilbert disease to be diagnosed if total
bilirubin > 3.0 times ULN

- AST and ALT ≤ 3.0 times ULN (unless due to hemolysis or CLL)

- Willing to provide blood samples

- Able to take acetylsalicylic acid (ASA) (81 or 325 mg) daily as prophylactic
anticoagulation (patients intolerant to ASA may use low molecular weight heparin)

- Not pregnant or nursing

- Negative pregnancy test

- Female patients must use effective double-method contraception beginning 1 month
prior to, during, and for 4 weeks after completion of study treatment

- Male patients must use effective contraception during and for 4 weeks after
completion of study treatment

- No comorbid conditions, including any of the following:

- New York Heart Association class III or IV heart disease

- Recent myocardial infarction (< 1 month)

- Uncontrolled infection

- Infection with HIV/AIDS

- No other active primary malignancy requiring treatment or that limits survival to ≤ 2
years

- No history of deep venous thrombosis or pulmonary embolism ≤ 12 months prior to study
registration

- No active hemolytic anemia requiring immunosuppressive or other pharmacologic therapy

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior chemotherapy or monoclonal antibody-based therapy for treatment of CLL

- Nutraceutical treatments with no established benefit in CLL (e.g., epigallocatechin
gallate or other herbal treatments) are not considered prior therapy

- More than 4 weeks since prior radiotherapy

- At least 4 weeks since prior major surgery

- No concurrent corticosteroids

- Concurrent low doses of steroids (e.g., < 10 mg of prednisone or equivalent dose
of other steroid) used for treatment of non-hematologic medical conditions
allowed

- Prior use of corticosteroids allowed

- No prior thalidomide or lenalidomide

- No concurrent therapeutic doses of coumadin-derivative anticoagulants (e.g.,
warfarin)

- Doses of ≤ 2 mg daily allowed for thrombosis prophylaxis

- Prophylactic doses of low molecular weight heparin allowed