Ibrutinib in Combination With GA101 (Obinutuzumab) in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Patients.

Inclusion Criteria

• Diagnosis of CLL
• Indication for treatment as defined by the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) Guidelines
• No previous treatment for CLL
• Males and females 65 years of age and older. Subjects under 65 years of age that meet any of the following criteria:

A. Documented refusal to be treated with chemotherapy agents B. Subjects that are not candidates for treatment with chemotherapy based on poor performance status (ECOG g>= 2), Cumulative Illness Rating Scale (CIRS score) >= 6 or creatinine clearance less than 70 mL/min

• Adequate hematologic, hepatic, and renal function
• Anticipated survival of at least 6 months
• Effective contraception is required while receiving Ibrutinib in combination with GA101-Obinutuzumab. For women of childbearing potential and men, effective contraception is required while receiving GA101-Obinutuzumab and for 365 days (12 months) after the last dose of the study drug

Exclusion Criteria

• Pregnant or nursing women
• Treatment with chemotherapy, monoclonal antibodies, or biological agents (e.g. lenalidomide) other than the investigational agents during the time of participation in this trial
• Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
• Severe or debilitating pulmonary disease
• Participation in any investigational drug study within 28 days prior to initiation of treatment within this protocol.
• History of second malignancy, other than non-melanoma skin cancer or in situ carcinoma of the cervix or the breast, unless the tumor was successfully treated at least 2 years before trial entry and with no evidence of relapse or active cancer.
• Active symptomatic fungal, bacterial and/or viral infection including evidence of infection with HIV, human T-cell leukemia virus 1 (HTLV-1) seropositive status.
• Evidence of active acute or chronic Hepatitis B (HBV)
• Evidence of active Hepatitis C (HCV): subjects with positive hepatitis C serology and positive HCV RNA test
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
• Known hypersensitivity to any of the study drugs
• Major surgery (within 4 weeks prior to the start of Cycle 1), except for procedures that are performed for diagnostic purposes
• Vaccination with a live vaccine within 28 days of the initiation of treatment.
• Concomitant use of warfarin or other Vitamin K antagonists
• Requirement to receive treatment with a strong cytochrome P450 (CYP) 3A inhibitor
• Chronic liver disease with hepatic impairment (Child-Pugh class B or C)