Phase II Clinical Study on SyB L-0501 in Patients With Indolent B-cell Non-Hodgkin's Lymphoma or Mantle Cell Lymphoma (Multicenter, Open-label Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 16
- 主要终点
- Overall response rate based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]
研究概览
简要总结
The purpose of this study is to assess the antitumor effects and safety of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell non-Hodgkin's lymphoma or mantle cell lymphoma.
详细描述
Indolent B-cell Non-hodgkin's lymphoma is treated mainly with radiation and chemotherapy using a combination of chemotherapies, such as purine-analogues and CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone). After the approval of an antibody therapy agent Rituximab®, it alone or combination with CHOP has been introduced. Bendamustine hydrochloride has a unique structure compared with the marketed agents, and has an innovative mechanism of action. Thus, it is expected that Bendamustine hydrochloride will provide new alternatives for patients with refractory/recurrent indolent B-cell Non-hodgkin's lymphoma.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-Hodgkin's lymphoma patients with prior therapy who satisfy the conditions listed below. No restrictions regarding gender.
- •Patients with histologically or cytologically confirmed indolent B cell Non-Hodgkin's lymphoma or mantle cell lymphoma.
- •Patients who had not received treatment for at least 4 weeks (for at least 12 weeks in the case of antibody therapy) after completion of prior therapy and who are judged to carry no effect from the prior therapy.
- •Patients aged from 20 to less than 75 years.
- •Performance Status (P.S.): 0 or
- •Patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions).
- •Patients from whom written consent to participate in this study has been obtained.
排除标准
- •Patients who meet any of the following criteria will be excluded.
- •Patients with apparent infections.
- •Patients with serious complications (hepatic failure or renal failure).
- •Patients with complication or history of serious heart failure (e.g. cardiac infarction, ischemic heart disease).
- •Patients with serious digestive symptoms (nausea/ vomiting/ diarrhea).
- •Patients who are known to be positive for HBV, HCV or HIC.
- •Patients receiving other investigational drugs within 3 months before registration in the study.
- •Patients with allogenic bone-marrow transplant.
- •Women who are pregnant, of childbearing potential, or lactating.
- •Patients who do not agree to contraception.
- •Otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.
结局指标
主要结局
Overall response rate based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]
时间窗: [Treatment period]
次要结局
- CR rate of overall results based on [Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas]([Treatment Period])