|Exclusion Criteria:||1) Has received treatment with rituximab, alemtuzumab, ofatumumab, or any other chemotherapeutic agent for CLL|
2) Has received an investigational therapy within 30 days of first dose of study drug or has not fully recovered from any toxic effect of that therapy.
3) Previous or concurrent additional malignancy except noninvasive, nonmelanomatous skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, or currently controlled (in remission or on hormonal therapy, e.g. prostate or breast cancer) with estimated survival in excess of 2 years.
4) Has any significant concurrent medical diseases or conditions, including: a. Clinically significant pulmonary dysfunction requiring oxygen therapy. b. Active infection (viral, bacterial, or fungal) requiring systemic therapy. Patients who are on prophylactic therapy are eligible. c. Prior allogeneic bone marrow transplant. d. Active autoimmune disease requiring immunosuppressive therapy. If the patient has an autoimmune complication secondary to CLL and it is controlled by immunosuppressive therapy then the patient may be enrolled (i.e., AIHA with no RBC transfusion and stable corticosteroid dose for 6 weeks prior to study entry). If the disease is active and uncontrolled with medication then they are to be excluded. If the patient has autoimmune disease not related to CLL they may not be enrolled if they are on any immunosuppressive therapy.
5) Has known positive serology for human immunodeficiency virus (HIV) or hepatitis C.
6) Is hepatitis B surface antigen or hepatitis B core antibody positive. Patients positive for hepatitis B surface antibody may be enrolled if both hepatitis B surface antigen and hepatitis B core antibody are negative. If the hepatitis B core antibody is the only test positive and it is the result of immunoglobulin treatment, then the patient may be enrolled if the HBV DNA is negative.
7) Is a female patient who is pregnant or breastfeeding.
8) Has known current drug or alcohol abuse.
9) Has current psychiatric disease that would interfere with the patient's ability to comply with the study protocol.
10) Has other severe, acute, or chronic medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration or may interfere with safety