A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior Treatment

Study Overview
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Brief Summary
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The purpose of this study is to evaluate response rate, survival, safety and tolerability of YM155 given in combination with rituximab in subjects with Non-Hodgkin's Lymphoma.

Detailed Description
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This is an outpatient study. All subjects enrolled in this study will receive YM155 and rituximab given during 14 day cycles. Each subject will be assessed at the end of each cycle to determine if he or she may continue to the next cycle. Each subject will be eligible to continue receiving the combination regimen in this study until one of the discontinuation criteria is met. If a subject discontinues treatment without progressive disease (PD) that subject will complete follow-up visits every 12 weeks for 1 year or until initiating another systemic anti-lymphoma treatment, exhibiting PD, or death. Each subject will be contacted by the study site every 12 weeks for survival following the End of Treatment Visit. The contacts will continue until death or for no more than 1 year.

Official Title
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A Phase II, Multicenter, Open-Label Study Of YM155 Plus Rituximab In Previously Treated Subjects With CD20-Positive B Cell Non-Hodgkin's Lymphoma Who Are Ineligible For Or Have Previously Received An Autologous Stem Cell Transplant

Conditions
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Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: YM155
* Biological: Rituximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any stage, histologically confirmed CD20-positive primary or transformed diffuse large B cell lymphoma (DLBCL)or grade 3 follicular lymphoma (FL) Ineligible for or have previously received an autologous stem cell transplant (ASCT) Relapsed following receipt of the last dose of systemic chemotherapy or ASCT At least one prior chemotherapy regimen. Prior chemotherapy regimen must have contained anthracycline (unless contraindicated) If the subject is female, she must be non-pregnant and non-lactating at the Baseline Visit. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period Eastern Cooperative Oncology Group (ECOG) performance status </= 1 Exclusion Criteria: Use of any standard/experimental anti-lymphoma drug therapy within 21 days of the Baseline Visit Use of systemic steroids within 5 days of the Baseline Visit (except for the purposes of pre-medication prior to study regimen treatment) Prior allogeneic stem cell transplant (SCT) The subject has been previously treated with YM155 The subject has known human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibody The subject has received other investigational therapy or procedures within 21 days prior to the first study drug administration

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YM155 plus rituximab<br> | Drug: YM155<br>* intravenous infusion<br>Biological: Rituximab<br>* intravenous infusion<br>* Other names: Mabthera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission) |  | After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed Complete remission rate |  | After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment | 
| Confirmed Partial remission rate |  | After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment | 
| Time to response |  | After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment | 
| Duration of response |  | After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment | 
| Clinical benefit rate |  | After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment | 
| Progression-free survival |  | After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment | 
| Overall survival |  | 1 year after the last subject completes treatment | 
| Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs) |  | After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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YM155, Non-Hodgkin's Lymphoma, relapsed, CD20-Positive