Patients
inadequate liver, tumor, myocardial infarction, angina, impaired pulmonary function, toxicity, human immunodeficiency virus infection, B-cell NHL, cardiac disease, interstitial lung disease, alopecia
TUMOR, UNCONTROLLED HYPERTENSION, MYOCARDIAL INFARCTION, HEART DISEASE, CHRONIC HEPATITIS, DIABETES MELLITUS, ALOPECIA, HUMAN IMMUNODEFICIENCY VIRUS INFECTION, SMALL LYMPHOCYTIC LYMPHOMA, SEIZURE DISORDERS, B-CELL NHL, CONGESTIVE HEART FAILURE, CARDIAC DISEASE, JC VIRUS INFECTION, ONCOLOGY, INTERSTITIAL LUNG DISEASE, PATHOLOGY, BLEEDING DIATHESIS
The study included Japanese patients aged ≥ 20 years with a histologically confirmed diagnosis (central pathology review) of one of the following types of indolent B-cell NHL: FL grade 1, 2, or 3a, small lymphocytic lymphoma with absolute lymphocyte count < 5 × 10Other inclusion criteria were: Eastern Cooperative Oncology Group (ECOG) performance status 0–2, life expectancy of 3 months or longer, adequate bone marrow, liver, and renal function as assessed within 7 days before starting study treatment, left ventricular ejection fraction ≥ lower limit of normal for the study center, and the availability of fresh or archival tumor tissue.Key exclusion criteria were: uncontrolled hypertension (blood pressure > 150/90 mmHg despite optimal medical management), type I or II diabetes mellitus (glycated hemoglobin > 8.5% or fasting blood glucose > 160 mg/dL at screening), history of cardiac disease or congestive heart failure, myocardial infarction within 6 months of study entry, active heart disease, new-onset angina within 3 months before study entry, treatment (chemotherapy, immunotherapy, radiotherapy, or investigational drug) targeting lesions within 4 weeks before study entry, evidence or history of a bleeding diathesis, history or concurrent conditions or interstitial lung disease or impaired pulmonary function, ongoing systemic corticosteroid therapy, unresolved toxicity attributed to prior treatment (other than alopecia), prior treatment with a PI3K inhibitor or strong cytochrome P450 3A4 inhibitors, known history of human immunodeficiency virus infection or chronic hepatitis B or C virus infection requiring treatment, seizure disorders, inadequate liver, renal, or bone marrow function (assessed as per laboratory values), and pregnant or lactating women.