Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma

Exclusion Criteria

• •Known active central nervous system or leptomeningeal 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 (Visit 2)
• •Pregnancy or breastfeeding
• •Ongoing alcohol or drug addiction
• •Known history of drug-induced liver injury, chronic active hepatitis C virus (HCV), chronic active hepatitis B virus (HBV), 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.
• •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
• •Prior therapy with any drug that inhibits Akt, Bruton tyrosine kinase (BTK), Janus kinase (JAK), mammalian target of rapamycin (mTOR), phosphatidylinositol 3 kinase (PI3K) (including idelalisib), or spleen tyrosine kinase (SYK)