Lenalidomide and Vaccine Therapy in Treating Patients With Early-Stage Asymptomatic Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Inclusion Criteria:

• Patients must have histologically identified chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as defined by the WHO classification of hematopoietic neoplasms

• CLL/SLL cells must demonstrate one or more of the following high-risk genomic features:

  • Del(17p13.1) as detected by fluorescence in-situ hybridization (FISH) in > 20% of cells
  • Del(11q22.3) as detected by FISH in > 20% of cells
  • Complex karyotype (≥ 3 cytogenetic abnormalities on stimulated karyotype)
  • Unmutated IgVH (≥ 98% sequence homology compared with germline sequence)

• None of the following:

  • Progressive splenomegaly and/or lymphadenopathy identified by physical examination or radiographic studies
  • Progressive lymphocytosis with total WBC ≥ 300,000/µL
  • Anemia (< 11 g/dL) or thrombocytopenia (< 100,000/μL) due to bone marrow involvement
  • Progressive lymphocytosis with an increase of > 50% over a 2-month period or an anticipated doubling time of < 6 months
• Patients must discontinue treatment with H2-blockers (cimetidine, ranitidine, etc.) prior to beginning protocol therapy
• Estimated life expectancy of greater than 24 months
• ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%)
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless secondary to Gilbert disease)
• AST/ALT ≤ 2.5 times ULN
• Creatinine normal or creatinine clearance ≥ 60 mL/min
• ANC ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Able to swallow capsules without difficulty
• No history of malabsorption syndrome; disease significantly affecting gastrointestinal function; resection of the stomach or small bowel; ulcerative colitis; symptomatic inflammatory bowel disease; or partial or complete bowel obstruction
• Negative serum or urine pregnancy test
• Fertile patients must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide; men must agree to use a latex condom during sexual contact with a female, even if they have had a successful vasectomy
• No presence of unintentional weight loss > 10% over the preceding 6 months
• No NCI CTCAE grade 2 or 3 fatigue
• No fever > 100.5° or night sweats for > 2 weeks without evidence of infection

• No patients with a recent history (within 6 months of study entry) of deep vein thrombosis/pulmonary embolism (DVT/PE)

  • Patients with a distant history (greater than 6 months before study entry) of venous thromboembolic disease are eligible, but should receive prophylactic aspirin or low-molecular weight heparin
• No history of allergic reactions attributable to compounds of similar chemical or biologic composition to thalidomide, lenalidomide, or any component of PCV7 or PCV13, including the diphtheria toxoid
• No prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject is considered by his or her physician to have a 2-year survival expectation
• No uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements
• HIV-positive patients with CD4 cell count ≥ 200/mm³ and viral load < 50 /mm³ will be eligible if they otherwise meet required hematologic parameters and are not receiving an antiviral agent with known or potential interaction with lenalidomide
• No patients who have developed erythema nodosum characterized by a desquamating rash while taking thalidomide or similar drugs in the past
• No prior therapy for chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), including chemotherapy, radiotherapy, and/or immunotherapy

• No corticosteroid use will be permitted within two weeks prior to study, except for maintenance therapy for a non-malignant disease

  • Maintenance therapy dose may not exceed 20 mg/day prednisone or equivalent
• No other concurrent investigational agents
• HIV-positive patients on combination antiretroviral therapy will be eligible if they otherwise meet required hematologic parameters and are not receiving an antiviral agent with known or potential interaction with lenalidomide
• No patients who have been treated for autoimmune hemolytic anemia or autoimmune thrombocytopenia within the last 6 months or are direct antiglobulin test/Coomb's test or indirect antiglobulin test positive at the time of screening