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

Study Overview
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Brief Summary
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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
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1 arm (Active), Phase 2 Study to evaluate response rate, efficacy, safety and tolerability of YM155

Official Title
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A Phase II Multicenter, Open-Label Study of YM155 in Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Subjects

Conditions
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Lymphoma, Large-Cell, Diffuse, Lymphoma, B-Cell Refractory

Intervention / Treatment
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* Drug: YM155


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: YM155<br>* Continuous IV infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 15 treatment cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, efficacy, pharmacokinetics, and tolerability |  | 15 treatment cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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YM155, Lymphoma, Large-Cell, Diffuse, Lymphoma, B-Cell, Treatment outcomes, Refractory