|Inclusion Criteria:||1) Male or female >/= 18 years of age.|
2) Diagnosis of B-cell CLL, with diagnosis established according to IWCLL criteria and documented within medical records.
3) CLL that warrants treatment (consistent with accepted criteria for initiation of therapy). Any of the following conditions constitute CLL that warrants treatment: a) Evidence of progressive marrow failure as manifested by the onset or worsening of anemia and/or thrombocytopenia, b) Massive (ie, lower edge of spleen >/= 6 cm below the left costal margin), progressive, or symptomatic splenomegaly, or c) Massive (ie, >/= 10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy, or d) Progressive lymphocytosis in the absence of infection, with an increase in blood ALC>/= 50% over a 2-month period or lymphocyte doubling time of <6 months (as long as initial ALC was ≥30,000/L), or
4) (Continued) e) Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy, or f) Constitutional symptoms, defined as any one or more of the following disease-related symptoms or signs occurring in the absence of evidence of infection: i) Unintentional weight loss of >/= 10% within the previous 6 months, or ii) Significant fatigue (>/= Grade 2), or iii) Fevers >100.5°F or 38.0°C for >/= 2 weeks, or iv) Night sweats for >1 month.
5) Presence of radiographically measurable lymphadenopathy (defined as the presence of >/= 1 nodal lesion that measures >/= 2.0 cm in the longest dimension [LD] and >/= 1.0 cm in the longest perpendicular dimension [LPD] as assessed by CT or MRI).
6) Prior treatment for CLL comprising any of the following: a) Prior treatment with >/=1 regimen containing a therapeutic anti-CD20 antibody (eg, rituximab, ofatumumab, GA-101) administered for >/=2 doses of antibody treatment, or b) Prior treatment with >/=2 regimens containing >/=1 cytotoxic agent (eg, fludarabine, pentostatin, cladribine, cyclophosphamide, chlorambucil, bendamustine) administered for >/=2 cycles of cytotoxic treatment Note: Prior anti-CD20 antibody or cytotoxic drugs may have been administered as single agents or as components of combination therapies. Subjects may also have received other commercially available therapies (eg, alemtuzumab, lenalidomide, corticosteroids, or others) or non-excluded investigational therapies. Each repeated course of the same single-agent or combination is considered an independent regimen.
7) In a subject whose last prior therapy contained an anti-CD20 antibody (eg, rituximab, ofatumumab, GA-101), evidence of disease improvement during that therapy or documentation of CLL progression >/=6 months after completion of that therapy. Note: Subjects who did not receive a therapeutic anti-CD20 antibody (eg, rituximab, ofatumumab, GA-101) as a component of the last prior therapy need not have experienced disease improvement or may have relapsed <6 months from the completion of the prior regimen.
8) Documentation of CLL progression <24 months since the completion of the last prior therapy for CLL.
9) Discontinuation of all therapy (including radiotherapy, chemotherapy, immunotherapy, systemic corticosteroids, or investigational therapy) for the treatment of CLL >/=3 weeks before randomization.
10) All acute toxic effects of any prior antitumor therapy resolved to Grade </=1 before randomization (with the exception of alopecia [Grade 1 or 2 permitted], neurotoxicity [Grade 1 or 2 permitted], or bone marrow parameters [Grades 1, 2, 3, or 4 permitted).
11) Karnofsky performance score of >/=40.
12) Appropriate for non-cytotoxic-containing therapy based on the presence of any of the following factors: a) Grade >/=3 neutropenia or thrombocytopenia attributable to cumulative myelotoxicity from prior administration of cytotoxic agents (as documented by bone marrow biopsy obtained since last prior therapy), or b) Estimated creatinine clearance (eCCr) <60 mL/min (as determined by the Cockcroft-Gault method), or c) A CIRS score of >6.
13) Required baseline laboratory data (within 4 weeks prior to randomization) as shown in the table below. Note: Confirmation should be considered for out-of-range values to determine if the abnormality is real or artifactual. Values should be obtained within the screening period and should generally be the most recent measurement obtained. Subjects with any degree of neutropenia, thrombocytopenia, or anemia due to CLL or prior therapy may enroll.
14) For female subjects of childbearing potential, willingness to abstain from heterosexual intercourse or use a protocol-recommended method of contraception from the screening visit (Visit 1) throughout the study treatment period and for 30 days following the last dose of study drug. Note: A female subject is considered to be of childbearing potential unless she has had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy, has medically documented ovarian failure (with serum estradiol and folliclestimulating hormone [FSH] levels within the institutional postmenopausal range and a negative serum or urine βHCG), or is menopausal (age ≥55 years with amenorrhea for ≥6 months).
15) For male subjects of childbearing potential and having intercourse with females of childbearing potential, willingness to abstain from heterosexual intercourse or use a protocol-recommended method contraception from the randomization visit (Visit 2) throughout the study treatment period and for 90 days following the last dose of study drug and to refrain from sperm donation from randomization (Visit 2) throughout the study treatment period and for 90 days following the last dose of study drug. Note: A male subject is considered able to father a child unless he has had a bilateral vasectomy with documented aspermia or a bilateral orchiectomy, or has ongoing testicular suppression with a depot luteinizing hormone-releasing hormone (LH-RH) agonist (eg, goserelin acetate [Zoladex®]), leuprolide acetate [Lupron®]), or triptorelin pamoate [Trelstar®]).
16) In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current CLL disease status, medical condition, and the potential benefits and risks of alternative treatments for CLL.
17) Willingness to comply with scheduled visits, drug administration plan, imaging studies, laboratory tests, other study procedures, and study restrictions. Note: Psychological, social, familial, or geographical factors that might preclude adequate study participation should be considered.
18) Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential benefits, possible side effects, potential risks and discomforts, and other pertinent aspects of study participation.