Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

Exclusion Criteria

• •Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation or pro-lymphocytic leukemia)
• •Known central nervous system involvement
• •Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
• •An individual organ/ system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system
• •Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
• •Inadequate renal function
• •History of prior malignancy, except for conditions as listed in the protocol if participants have recovered from the acute side effects incurred as a result of previous therapy
• •Use of investigational agents or concurrent anti-cancer treatment within the last 4 weeks of registration
• •Participants with active bacterial, viral, or fungal infection requiring systemic treatment within the last two months prior to registration
• •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
• •Hypersensitivity to chlorambucil, obinutuzumab, or venetoclax or to any of the excipients
• •Pregnant women and nursing mothers
• •Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology) or positive test result for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing)
• •Participants with known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus-1 (HTLV-1)
• •Requires the use of warfarin, marcumar, or phenprocoumon
• •Received agents known to be strong and moderate Cytochrome P450 3A inhibitors or inducers within 7 days prior to the first dose of study drug