Elevate CLL TN: Study of Obinutuzumab + Chlorambucil, Acalabrutinib (ACP-196) + Obinutuzumab, and Acalabrutinib in Subjects With Previously Untreated CLL

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.