Efficacy and Safety of Idelalisib in Combination With Obinutuzumab Compared to Chlorambucil in Combination With Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia

Exclusion Criteria

• •Known histological transformation from CLL to an aggressive lymphoma (ie, Richter transformation)
• •Known presence of myelodysplastic syndrome
• •Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of randomization
• •Ongoing liver injury
• •Ongoing drug-induced pneumonitis
• •Ongoing inflammatory bowel disease
• •History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
• •Ongoing immunosuppressive therapy other than corticosteroids
• •Concurrent participation in another therapeutic clinical trial
• •Undergone major surgery within 30 days prior to randomization
• •Known hypersensitivity or intolerance to any of the active substances or excipients in the formulations for idelalisib, obinutuzumab, or chlorambucil
• •History of non-infectious pneumonitis
• •Received last dose of study drug on another therapeutic clinical trial within 30 days prior to randomization