A Phase II Multicenter, Open-Label 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