Study of YM155 in Refractory Diffuse Large B-cell Lymphoma (DLBCL) Subjects

Exclusion Criteria

• •Transformed, composite or discordant lymphoma
• •Therapy for lymphoma within 21 days prior to the first dose of YM155
• •Within 4 weeks of the screening FDG-PET scan, receipt of the following:
• •Radiation therapy
• •Surgical procedures (except biopsies and central catheter / port placement)
• •Active infection (bloodstream or deep tissue)
• •Inadequate marrow, hepatic and/or renal function
• •Serum creatinine \> 1.5 x ULN or calculated serum creatinine clearance \< 60 mL/min
• •Absolute Neutrophil Count (ANC) \< 750/mm3
• •Platelet \< 50,000/mm3
• •Alanine Transaminase (ALT) and Aspartate Transaminase (AST) \> 2.5 x ULN; \> 5 x ULN if secondary to liver metastases
• •Treated with \> 3 prior treatment regimens. The following should be considered:
• •Planned maintenance therapy should be considered as part of the previous treatment regimen
• •Any preparative treatment (salvage chemotherapy, high-dose chemotherapy, radiation therapy, etc.) should be included with the autologous BMT or PBSCT as one treatment
• •Prior allogeneic BMT or PBSCT
• •Previously treated with YM155
• •Other investigational therapy or procedures within 28 days
• •Known HIV, hepatitis B surface antigen, or hepatitis C antibody
• •Other malignancy requiring treatment within 2 years
• •Significant and/or uncontrolled cardiac, renal, hepatic, or other systemic disorders or significant psychological conditions that in the Investigator's judgment would jeopardize subject enrollment or compliance