Mechanisms of Idelalisib-Associated Diarrhea in Patients with Relapsed Chronic Lymphocytic Leukemia, Indolent Non-Hodgkin Lymphoma, or Small Lymphocytic Lymphoma

Inclusion Criteria

• Food and Drug Administration (FDA)-approved indications for idelalisib of relapsed, histologically confirmed B-cell indolent non-Hodgkin lymphoma (iNHL) or chronic lymphocytic leukemia (CLL)
• For iNHL: measurable nodal disease, defined as the presence of >= 1 nodal lesion that measures >= 2 cm in a single dimension as assessed by computed tomography (CT) or magnetic resonance imaging (MRI)
• Discontinuation of all other therapies (including radiotherapy or chemotherapy) for the treatment of iNHL >= 3 weeks before initiation of study treatment
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Absolute neutrophil count > 750
• Platelets > 50,000
• Total bilirubin < 2 X institutional upper limit of normal (ULN)
• Aspartate transaminase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/ alanine transferase (ALT) (serum glutamate pyruvate transaminase [SPGT]) < 3 X institutional ULN
• Creatinine < 2 X institutional ULN
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Ability to understand and the willingness to sign a written informed consent; all patients must have signed, witnessed informed consent prior to registration

Exclusion Criteria

• Prior exposure to idelalisib
• Known histological transformation from iNHL to diffuse large B-cell lymphoma or Richter’s transformation for CLL
• Ongoing treatment with any other investigational agents
• Known central nervous system (CNS) involvement of lymphoma (CNS staging not required)
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to idelalisib
• Uncontrolled inter-current illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Known human immunodeficiency virus (HIV) infection (HIV testing not required)
• Known John Cunningham (JC) virus infection and/or progressive multifocal leukoencephalopathy (PML)
• Clinically active hepatitis A, B, or C infections
• NOTE: Patients with chronic hepatitis C virus (HCV) or hepatitis B virus (HBV) infection may enroll if other laboratory criteria are met; those with HBV surface antigen positivity may enroll only if maintained on appropriate suppressive antiviral therapy for the duration of enrollment in the trial
• Pregnancy or active nursing of an infant