Tazemetostat and Venetoclax in Relapsed/Refractory Non-Hodgkin Lymphoma

Eligibility Criteria

• * Histologically confirmed, biopsy-proven diagnosis of FL or DLBCL.
• * Subjects must have been treated with at least one prior line of therapy for lymphoma with evidence of disease progression.
• * Subjects are eligible if they have progressed after ASCT OR if they are ineligible for ASCT
• * Significant cardiovascular impairment, such as history of congestive heart failure, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug
• * Known hypersensitivity to any of the study drugs
• * History of other cancer (some exceptions apply)
• * Known CNS (brain or spinal cord) involvement at diagnosis
• * Richter's transformation from CLL
• * Evidence of uncontrolled systemic infection (viral, bacterial, or fungal)
• * Major surgery within 3 weeks prior to the start of study treatment
• * Venous thrombosis or pulmonary embolism within the last 3 months before starting study
• * Uncontrolled infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus 1
• * Pregnant or lactating (people capable of becoming pregnant or getting someone else pregnant must be willing to use highly effective birth control)
• * Malabsorption syndrome or other condition that precludes enteral route of administration
• * Inability to swallow tablets
• * Known allergy to both xanthine oxidase inhibitors and rasburicase
• * Clinically significant history of liver disease, including but not limited to viral or other hepatitis, current alcohol abuse, or cirrhosis
• * Active hepatitis C (defined as a positive HCV viral load)
• * Chronic use of moderate or strong CYP3A4 modulators (inhibitor or inducer); chronic use of a P-gp inhibitor, or a P-gp substrate with a narrow therapeutic index; or use of certain other prohibited medications
• * Prior exposure to either tazemetostat or venetoclax
• * Prior history of T-LBL/T-ALL
• * Previous solid organ transplant
• * Requires the use of warfarin (because of potential drug-drug interactions that may potentially increase the exposure of warfarin)
• * Vaccination with live vaccines within 28 days prior to treatment
• * Consumed grapefruit or grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study drug