Study of Alisertib (MLN8237) in Adults With Aggressive Non-Hodgkin's Lymphoma

Exclusion Criteria

• •1. Pregnant or lactating females.
• •2. Known human immunodeficiency virus (HIV) positive or AIDS-related illness.
• •3. Any serious medical or psychiatric illness that could interfere with the completion of treatment.
• •4. Total bilirubin ≥ 1.5 × the upper limit of normal (ULN).
• •5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≥ 2.5 × the ULN. AST, ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to their underlying hematological disorder.
• •6. Absolute neutrophil count (ANC) \< 1,250/mm\^3.
• •7. Platelet count \< 75,000/mm\^3.
• •8. Calculated creatinine clearance \< 30 mL/minute.
• •9. Autologous stem cell transplant less than 6 months prior to enrollment.
• •10. Participants who have undergone allogeneic stem cell or organ transplantation.
• •11. Systemic antineoplastic therapy including glucocorticoids (\> 15 mg prednisone/day or equivalent), or treatment with an investigational agent within 14 days preceding the first dose of study drug treatment.
• •12. Participants who have received treatment with nitrosoureas, mitomycin C, rituximab, alemtuzumab, or other unconjugated antibody treatment, within 12 weeks prior to first dose.
• •13. Participants who have received treatment with radioimmunoconjugates or within 12 weeks prior to first dose.
• •14. Participants who have received radiotherapy within 21 days prior to first dose.
• •15. Myocardial infarction within 6 months of enrollment or current history of New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia.
• •16. Major surgery within 14 days prior to the first dose.
• •17. Infection requiring systemic antibiotic therapy within 14 days prior to the first dose or other serious infection.
• •18. Clinically uncontrolled central nervous system (CNS) involvement.
• •19. Inability to swallow capsules.
• •20. History of uncontrolled sleep apnoea syndrome and other conditions that could result in excessive daytime sleepiness (eg, Chronic obstructive pulmonary disease - COPD).