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

• Status: Terminated
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

A study in subjects with a type of B cell lymphoma (DLBCL)to evaluate the response rate, efficacy, safety and tolerability of YM155

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc

Criteria

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