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

Inclusion Criteria:

* Male or female subjects aged 18 years or older
* Histologically confirmed primary DLBCL of any stage
* Refractory to the last treatment regimen
* Previously treated with the following treatment regimens:
* Anthracycline-based combination chemotherapy with rituximab
* Second-line combination chemotherapy
* Autologous BMT if the subject was eligible and did not refuse the procedure
* At least one measurable lesion defined as \> 1.5 cm in the longest diameter
* No known central nervous system involvement
* ECOG performance status \< 2
* Life expectancy \> 12 weeks
* If female, non-pregnant and non-lactating
* IRB-approved consent and HIPAA Authorization

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