Phase II Clinical Study of KW-0761 in Patients With CCR4-Positive Adult T-cell Leukemia-Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pharmacokinetics-Plasma KW-0761 Concentrations
研究概览
简要总结
To evaluate the efficacy, safety and pharmacokinetic profiles of KW-0761, the anti-CC chemokine receptor 4 (CCR4) antibody, when administered weekly for 8 weeks as an intravenous infusion at a dose of 1.0 mg/kg in relapsed subjects with CCR4-positive adult T-cell leukemia-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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive for serum anti-HTLV-I antibody
- •Acute-, lymphoma-, or chronic-type with poor prognostic factors specified in the past
- •Positive for CCR4
- •Relapsed subject after the response (CR, CRu or PR) in the last previous chemotherapy
- •Received at least one prior chemotherapy
- •Subjects with an interval of four weeks or more between the last day of the previous treatment and the scheduled day of the first KW-0761 treatment
- •PS of 0 to 2
- •Negative for HBs antigen and for HBV-DNA by a real-time PCR
排除标准
- •A history of transplantation such as hematopoietic stem cells
- •Positive for HCV antibody or HIV antibody
- •Active multiple cancers at the time of starting this clinical study
- •Previous history of allergic reactions after receiving antibody products
- •Requiring continuous systemic treatment with a steroid
- •Requiring such radiotherapy after starting this clinical study
- •Treated with any investigational drug other than KW-0761 within three months
结局指标
主要结局
Pharmacokinetics-Plasma KW-0761 Concentrations
时间窗: 0 to 7 days post final dose
Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling. The baseline and maximum time point at which Cmax and Ctrough were collected are 0 to 7 days post-dose.
Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days)
时间窗: 0 to 7 days post final dose
Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling.
Overall Response Rate (ORR)
时间窗: From date of first subject's consent to participate in the study until the date of last protocol-specified examination for last subject completed, assessed up to 14 months.
Response rate defined as the proportion of responders relative to the total population and its exact 95% confidence interval were calculated for best overall response. The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).Overall Response (OR)= CR + PR.
Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2)
时间窗: 0 to 28 days post final dose and follow-up examinations (1 month and 3 months after the end of the post-dosing observation period).
次要结局
- Overall Survival (OS)(Baseline to response)
- Progression Free Survival (PFS)(Baseline to response)