Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Inc
1 arm (Active), Phase 2 Study to evaluate response rate, efficacy, safety and tolerability of YM155
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
