Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma

Inclusion Criteria:

- Histologically confirmed diagnosis of B-cell lymphoma

- No previous systemic treatment for lymphoma

- Subject demonstrates need for treatment for lymphoma

- Ann-Arbor Stage 2 (noncontiguous), 3, or 4 disease

- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy

- Adequate performance status

- Required baseline laboratory data within protocol-specified parameters

Exclusion Criteria:

- Known history of transformed lymphoma or diffuse large cell lymphoid malignancy

- Known history of, or clinically apparent, central nervous system (CNS) lymphoma or
leptomeningeal lymphoma

- Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of
enrollment

- Known history of drug-induced liver injury, chronic active hepatitis B (HBV), chronic
active hepatitis C (HCV), alcoholic liver disease, non-alcoholic steatohepatitis,
cirrhosis of the liver, portal hypertension, primary biliary cirrhosis, or ongoing
extrahepatic obstruction caused by cholelithiasis

- Ongoing inflammatory bowel disease

- Known human immunodeficiency virus (HIV) infection

- History of prior allogeneic bone marrow progenitor cell or solid organ
transplantation

- Ongoing immunosuppressive therapy, including systemic corticosteroids (> 10 mg
prednisone or equivalent/day) with the exception of the use of topical, enteric, or
inhaled corticosteroids as therapy for comorbid conditions and systemic steroids for
autoimmune anemia and/or thrombocytopenia