A Phase 1 Study of Brentuximab Vedotin Administered Sequentially and Concurrently With Multi-Agent Chemotherapy as Front-Line Therapy in Patients With CD30-Positive Mature T-Cell and NK-Cell Neoplasms, Including Systemic Anaplastic Large Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 39
- 试验地点
- 11
- 主要终点
- Incidence of adverse events and laboratory abnormalities
研究概览
简要总结
The purpose of this study is to assess the safety profile of brentuximab vedotin sequentially and in combination with multi-agent chemotherapy in front-line treatment for CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma. It is a phase 1, open-label, dose escalation study in three arms designed to define the MTD, PK, immunogenicity, and anti-tumor activity of brentuximab vedotin in sequence and in combination with multi-agent front-line chemotherapy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment-naive CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma
- •Measurable disease of at least 1.5 cm
- •ECOG performance status less than or equal to 2
排除标准
- •Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy
- •Current diagnosis of primary cutaneous anaplastic large cell lymphoma, mycosis fungoides, Sezary syndrome or other primary cutaneous lymphomas; extranodal NK/T-cell lymphoma, nasal type
- •History of another primary malignancy that has not been in remission for at least 3 years
- •Left ventricular ejection fraction <45% or symptomatic cardiac disease, or myocardial infarction within the past 12 months
- •Viral, bacterial, or fungal infection within two weeks prior to the first dose of brentuximab vedotin
- •Known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus positive status
研究组 & 干预措施
2
Combination
干预措施: cyclophosphamide (Drug)
1
Sequential
干预措施: brentuximab vedotin (Drug)
1
Sequential
干预措施: cyclophosphamide (Drug)
1
Sequential
干预措施: prednisone (Drug)
1
Sequential
干预措施: doxorubicin (Drug)
1
Sequential
干预措施: vincristine (Drug)
2
Combination
干预措施: brentuximab vedotin (Drug)
2
Combination
干预措施: doxorubicin (Drug)
2
Combination
干预措施: prednisone (Drug)
3 Brentuximab vedotin/CH-P
Combination
干预措施: brentuximab vedotin (Drug)
3 Brentuximab vedotin/CH-P
Combination
干预措施: cyclophosphamide (Drug)
3 Brentuximab vedotin/CH-P
Combination
干预措施: doxorubicin (Drug)
3 Brentuximab vedotin/CH-P
Combination
干预措施: prednisone (Drug)
结局指标
主要结局
Incidence of adverse events and laboratory abnormalities
时间窗: Through 1 month after last dose
次要结局
- Overall survival(Every 3 months until death or study closure)
- Brentuximab vedotin concentration in blood(Through 1 month after last dose)
- Antitherapeutic antibodies in blood(Through 1 month after last dose)
- Best clinical response(Through 1 month after last dose)
- Progression-free survival(Until disease progression or study closure)