Trial of Idelalisib in Patients With Relapsed Diffuse Large B-cell Lymphoma

Exclusion Criteria

• •1. Prior allogeneic hematopoietic stem cell transplant (HSCT).
• •2. Prior treatment with PI3K inhibitors.
• •3. Serum total bilirubin ≥ 1.5 x ULN (unless elevated due to Gilbert's syndrome).
• •4. Serum ALT and AST ˃ 2.5 x ULN.
• •5. Estimated Creatinine Clearance \< 10 ml/min.
• •6. Known seropositivity for human immunodeficiency virus (HIV).
• •7. Known history of drug induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, on-going extra-hepatic obstruction caused by cholelithiasis, cirrhosis of the liver or portal hypertension.
• •8. Known history of drug induced pneumonitis.
• •9. On-going inflammatory bowel disease.
• •10. Evidence of serious active infection (eg, requiring an intravenous \[IV\] antibiotic, antiviral, or antifungal agent), or subjects with a recent history of deep tissue infections such as fascitis or osteomyelitis.
• •11. Chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational drugs/devices \<10 days before first dose of investigational product in this study. Subjects receiving high doses of corticosteroids must have been tapered to a stable dose at least 7 days before the first dose of investigational product.
• •12. Pregnant or breastfeeding women.
• •13. Symptomatic central nervous system (CNS) NHL; a lumbar puncture is not required unless CNS involvement with NHL is clinically suspected.
• •14. Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition).
• •15. Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. Subjects with previous malignancies are eligible provided that they have been disease free for \>2 years.
• •16. Previous myocardial infarction or pulmonary hypertension \<6 months before first dose of investigational product.
• •17. History of clinically significant ventricular arrhythmia, prolonged QTc interval or unexplained syncope.
• •18. Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.