Dose Optimization Study of Idelalisib in Follicular Lymphoma

Key Inclusion Criteria:

- Histologically confirmed diagnosis of B-cell follicular lymphoma (FL), and grade
limited to 1, 2, or 3a based on criteria established by the WHO 2008 classification of
tumors of hematopoietic and lymphoid tissues

- Relapsed or refractory FL and have received at least 2 lines of prior therapy for FL
and have no other therapeutic options

- Ann-Arbor Stage 2 (non-contiguous), 3, or 4 disease per Lugano Classification
Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined
as the presence of ≥ 1 lesion that measures ≥ 1.5 cm in the longest dimension (LD) and
≥ 1.0 cm in the longest perpendicular dimension (LPD) as assessed by positron emission
tomography-computed tomography (PET-CT), computed tomography (CT) or magnetic
resonance imaging (MRI)

- Required baseline central laboratory data in protocol.

- For female individuals of childbearing potential and male individuals of reproductive
potential, willingness to use a protocol- recommended method of contraception

- Lactating females must agree to discontinue nursing

- Willing and able to comply with scheduled visits, drug administration plan, imaging
studies, laboratory tests, other study procedures, and study restrictions including
mandatory prophylaxis for Pneumocystis jirovecii pneumonia (PJP)

Key Exclusion Criteria:

- History of lymphoid malignancy other than FL (eg, diffuse large B-cell lymphoma)

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

- Known presence of intermediate- or high-grade myelodysplastic syndrome.

- Known history of serious allergic reaction including anaphylaxis or Stevens- Johnson
syndrome/ toxic epidermal necrolysis

- History of a non-lymphoid malignancy except for protocol allowed exceptions

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

- History of or ongoing drug-induced pneumonitis

- History of or 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

- Concurrent participation in another therapeutic clinical trial

- Prior treatment with phosphatidylinositol 3-kinase (PI3K) inhibitors

- Cytomegalovirus (CMV)- Ongoing infection, treatment, or prophylaxis within 28 days
prior to the Screening Visit CMV test

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.