Efficacy and Safety Study of Idelalisib in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma

Key Inclusion Criteria:

- Age ≥ 18 years

- Karnofsky performance score of ≥ 60 (Eastern Cooperative Oncology Group [ECOG]
performance score of 0, 1, or 2)

- Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited
to the following:

- Follicular lymphoma (FL)

- Small lymphocytic lymphoma (SLL) with absolute lymphocyte count

- Lymphoplasmacytic lymphoma (LPL), with or without associated Waldenstroms
Macroglobulinemia (WM)

- Marginal zone lymphoma (MZL) (splenic, nodal, or extranodal)

- Prior treatment with ≥ 2 prior chemotherapy-based or immunotherapy-based regimens for
iNHL

- Presence of radiographically measurable lymphadenopathy or extranodal lymphoid
malignancy

- Prior treatment with rituximab and with an alkylating agent (eg, bendamustine,
cyclophosphamide, ifosfamide, chlorambucil, melphalan, busulfan, nitrosoureas) for
iNHL

- Lymphoma that is refractory to rituximab and to an alkylating agent

- Discontinuation of all other therapies for treatment of iNHL ≥ 3 weeks before Visit 2

- For men and women of childbearing potential, willingness to abstain from sexual
intercourse or employ an effective method of contraception during the study drug
administration and follow-up periods

- Willingness and ability to provide written informed consent and to comply with the
protocol requirements

Key Exclusion Criteria:

- Central nervous system or leptomeningeal lymphoma

- Known histological transformation from iNHL to diffuse large B-cell lymphoma.

- History of a non-lymphoma malignancy except for the following: adequately treated
local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ,
superficial bladder cancer, localized prostate cancer, other adequately treated Stage
1 or 2 cancer currently in complete remission, or any other cancer that has been in
complete remission for ≥ 5 years

- Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral
upper respiratory tract infections) at the time of initiation of study treatment

- Pregnancy or breastfeeding

- Ongoing alcohol or drug addiction

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

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

- Ongoing immunosuppressive therapy, including systemic corticosteroids. Patients may be
using topical or inhaled corticosteroids.

- Prior therapy with idelalisib

- Exposure to another investigational drug within 3 weeks prior to start of study
treatment.

- Concurrent participation in another therapeutic treatment trial.

- Prior or ongoing clinically significant illness, medical condition, surgical history,
physical finding, ECG finding, or laboratory abnormality that, in the investigator's
opinion, could affect the safety of the patient, alter the absorption, distribution,
metabolism or excretion of the study drug, or impair the assessment of study results

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