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

Each participant must meet all of the following inclusion criteria to be enrolled in the study:

• Participant must have histological or cytological diagnosis of a hematological malignancy of the following types that has relapsed or was refractory to prior therapy:
• Diffuse large B-cell lymphoma
• Mantle cell lymphoma
• Burkitt's lymphoma
• Precursor B-lymphoblastic leukemia/lymphoma
• T-cell lymphoma, excluding primary cutaneous T-cell lymphoma
• Transformed follicular lymphoma with ≥ 50% diffuse large cell component.
• Male or female participants 18 years or older.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Measurable disease.

Exclusion criteria include the following:

• Pregnant or lactating females.
• Known human immunodeficiency virus (HIV) positive or AIDS-related illness.
• Any serious medical or psychiatric illness that could interfere with the completion of treatment.
• Total bilirubin ≥ 1.5 × the upper limit of normal (ULN).
• 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.
• Absolute neutrophil count (ANC) 15 mg prednisone/day or equivalent), or treatment with an investigational agent within 14 days preceding the first dose of study drug treatment.
• Participants who have received treatment with nitrosoureas, mitomycin C, rituximab, alemtuzumab, or other unconjugated antibody treatment, within 12 weeks prior to first dose.
• Participants who have received treatment with radioimmunoconjugates or within 12 weeks prior to first dose.
• Participants who have received radiotherapy within 21 days prior to first dose.
• 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.
• Major surgery within 14 days prior to the first dose.
• Infection requiring systemic antibiotic therapy within 14 days prior to the first dose or other serious infection.
• Clinically uncontrolled central nervous system (CNS) involvement.
• Inability to swallow capsules.
• History of uncontrolled sleep apnoea syndrome and other conditions that could result in excessive daytime sleepiness (eg, Chronic obstructive pulmonary disease - COPD).