Rituximab, Pentostatin, Cyclophosphamide, and Lenalidomide in Treating Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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