Lymphoma, B-Cell Refractory, Lymphoma, Large-Cell, Diffuse
Conditions
Keywords
Lymphoma, Large-Cell, Diffuse, Lymphoma, B-Cell, YM155, Treatment outcomes, Refractory
Brief summary
A study in subjects with a type of B cell lymphoma (DLBCL)to evaluate the response rate, efficacy, safety and tolerability of YM155
Detailed description
1 arm (Active), Phase 2 Study to evaluate response rate, efficacy, safety and tolerability of YM155
Interventions
DRUGYM155
Continuous IV infusion
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | 15 treatment cycles |
Secondary
| Measure | Time frame |
|---|---|
| Safety, efficacy, pharmacokinetics, and tolerability | 15 treatment cycles |
Countries
Canada, France, Spain, United States
Outcome results
None listed