Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Adequate hematopoietic function: (i) Hemoglobin ≥10.0 g/dL within 14 days of starting therapy (participant may receive red blood cell [RBC] transfusion within 14 days). (ii) Absolute neutrophil count ≥1000 cells/mm³ (use of granulocyte growth factors prior to and during the study is acceptable). (iii) Platelet count ≥100,000/mm³ within 14 days of starting therapy (use of platelet growth factors prior to and during the study is acceptable). ... Any of the following laboratory abnormalities: (i) A circulating lymphocyte count of >50,000/L. (ii) Hepatic dysfunction: bilirubin >2.0x ULN (except participants with Gilbert's syndrome: total bilirubin of >3x ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2.5x ULN. In participants with known liver involvement of their DLBCL, AST and ALT >5x ULN. (iii) Severe renal dysfunction: estimated creatinine clearance of <30 mL/min, measured in 24-hour urine or calculated using the formula of Cockroft and Gault [(140-Age)*Mass (kg)/(72*creatinine mg/dL); multiply by 0.85 if female]. ... Unstable cardiovascular function: (i) Symptomatic ischemia, or (ii) Uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on anti-arrhythmia are excluded; 1st degree atrioventricular block or asymptomatic left anterior fascicular block /right bundle branch block will not be excluded), or (iii) Congestive heart failure of New York Heart Association Class ≥3, or (iv) Myocardial infarction within 3 months.