Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma (Untreated Primary Disease)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 19
- 主要终点
- Complete response rate in the best overall response assessment for antitumor effect
研究概览
简要总结
This is a multicenter, randomized, open-label, parallel-group study to compare mLSG15 + KW-0761 to mLSG15 in subjects with CCR4-positive adult T-cell leukemia-lymphoma (untreated primary disease). The primary variable is an efficacy of KW-0761 used as an add-on therapy to mLSG15 as measured in terms of complete response rate (CR/CRu) in the best overall response assessment for antitumor effect. The secondary variables include response rate (CR/CRu/PR) in the best overall response assessment for antitumor effect, complete or response rates by lesion site in the best overall response assessment for antitumor effect, progression-free survival and overall survival. The safety and pharmacokinetic profiles of KW-0761 will be also determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subjects who have been positive for serum anti-human T-cell lymphotropic virus type I antibody
- •Subjects with hematologically or pathohistologically confirmed as peripheral lymphoid tumor which surface antigen analysis has identified to be of T-cell origin
- •Subjects who have been classified into acute subtype, the lymphoma subtype or chronic subtype with poor prognostic factors
- •Subjects who have been positive for CCR4 by CCR4 expression analysis
- •Subjects who have never been treated for adult T-cell leukemia-lymphoma
- •Subjects who have presented enlarged lymph nodes, tumor nodules in extranodal organs, abnormal lymphocytes in peripheral blood or cutaneous lesions
- •Subjects with a performance status of 0 to 2
- •Subjects who have been negative for HBs antigen and anti-HCV antibody
- •Subjects who have given written voluntary informed consent to participate in the study
排除标准
- •Subjects who are scheduled for transplant therapy such as hematopoietic stem-cell transplantation
- •Subjects who had myocardial infarction within 12 months before study enrollment or who have cardiac disease that may worsen during treatment with doxorubicin
- •Subjects who have been positive for anti-HIV antibody
- •Subjects with active multiple cancer
- •Subjects with a history of allergic reactions to therapeutic antibodies
- •Subjects who require emergency radiotherapy for treating the symptoms caused by bulky masses or who may require such radiotherapy after the start of the study
- •Subjects who are pregnant, lactating or of childbearing potential, or who are planning to have children
研究组 & 干预措施
mLSG15
干预措施: VCAP/AMP/VECP(mLSG15) (Drug)
mLSG15 + KW-0761
干预措施: KW-0761 (Biological)
结局指标
主要结局
Complete response rate in the best overall response assessment for antitumor effect
时间窗: After cycle 2 and cycle 4
次要结局
- Response rate in the best overall response assessment for antitumor effect, complete or response rates by lesion site in the best overall response assessment for antitumor effect(After cycle 2 and cycle 4.)
- Progression-free survival and Overall survival(During the study period at least once every two months in the first year and once every three months in the second and subsequent years.)
- Adverse events(During the study period)
- anti-KW-0761 antibody(Before 1st and 5th dosing, 14 days after 8th or last dosing and at the start of post-treatment.)
- Plasma KW-0761 concentrations and pharmacokinetic parameters(Before and after 1st, 2nd, 3rd, 4th, 5th, 6th, 7th and 8th dosing, 14 days after 8th or last dosing, and at the start of post-treatment.)