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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 19
- 主要终点
- Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
YM155 plus rituximab
干预措施: YM155 (Drug)
YM155 plus rituximab
干预措施: Rituximab (Biological)
结局指标
主要结局
Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission)
时间窗: After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment
次要结局
- Overall survival(1 year after the last subject completes treatment)
- Confirmed Complete 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)
- Progression-free survival(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)
- Clinical benefit rate(After the last non-progressing subject receives 8 cycles of treatment or discontinues the 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)