A Multicenter, Open Study to Assess the Tolerability, Pharmacokinetics and Antitumor Effect of Bendamustine Hydrochloride (SyB L-0501: 90 or 120 mg/m2/Day) Administered Intravenously for Two Days in Patients With Indolent Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Non-Hematological toxicity; > grade three(CTCAE v.3.0), during the treatment cycle (twenty one days)
研究概览
简要总结
The purpose of this study is to assess the tolerability, pharmacokinetics and antitumor effect of bendamustine hydrochloride (SyB L-0501) in patients with indolent B-cell Non-Hodgkin's 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 indolent B-cell Non-hodgkin's lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Indolent B cell 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.
- •Patients who had not received treatment (chemotherapy, antibody therapy and radiation/ radiotherapy) for more than 4 weeks following prior therapy and who are judged to carry no effect from the prior therapy.
- •Patients aged from 20 to less than 75 years.
- •Patients who had agreed in-patient during first course therapy.
- •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 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
Non-Hematological toxicity; > grade three(CTCAE v.3.0), during the treatment cycle (twenty one days)
次要结局
- All adverse events or adverse reactions, during the treatment cycle (twenty one days)
- Pharmacokinetics profile