- Men and women: ≥ 65 years of age OR > 18 and < 65 years of age, provided that they meet at least one of the following criteria:
1. Creatinine clearance 30 to 69 mL/min.
2. A score higher than 6 on the Cumulative Illness Rating Scale-Geriatric.
- ECOG performance status of 0, 1, or 2.
- Diagnosis of CD20+ CLL.
- Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment.
- Meet the following laboratory parameters:
1. ANC ≥ 750 cells/μL, or ≥ 500 cells/μL in subjects with documented bone marrow involvement, and independent of growth factor support 7 days before assessment.
2. Platelet count ≥ 50,000 cells/μL, or ≥ 30,000 cells/μL in subjects with documented bone marrow involvement, and without transfusion support 7 days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded.
3. Serum AST and ALT/SGPT ≤ 3.0 x ULN.
4. Total bilirubin ≤ 1.5 x ULN.
5. Estimated creatinine clearance ≥ 30 mL/min.
- Any prior systemic treatment for CLL.
- Known CNS lymphoma or leukemia.
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome.
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
- Major surgery within 4 weeks before first dose of study drug.
- Prior malignancy, except for adequately treated lentigo maligna melanoma, non-melanomatous skin cancer, in situ cervical carcinoma, or other malignancy treated with no evidence of active disease > 3 years before Screening and at low risk for recurrence.
- Significant cardiovascular disease within 6 months of screening.
- Known history of infection with HIV.
- History of stroke or intracranial hemorrhage within 6 months before randomization.
- Known history of a bleeding diathesis.
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 7 days of first dose of study drug.
|Maximum Eligible Age:||N/A|
|Minimum Eligible Age:||18 Years|