NCT01196208No Longer Available不适用
An Open-label, Treatment-option Protocol of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma, Systemic Anaplastic Large Cell Lymphoma, or CD30-positive Cutaneous T-cell Lymphoma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- Seagen Inc.
- 试验地点
- 31
研究概览
简要总结
The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001
详细描述
The protocol was amended to reflect the change from a phase 2/3 to a study with an expanded access program (EAP) in the US that would include patients with ALCL and HL. A later amendment allowed patients with CD30-positive cutaneous T-cell lymphoma to enroll. Enrollment may continue and patients may receive brentuximab vedotin treatment on study until the drug is commercially approved and available to patients in a geographic region.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participated in either the SGN35-005 or C25001 clinical study and experienced progression. Patients who received brentuximab vedotin in C25001 must have had an objective response at the time of discontinuation.
- •Completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of brentuximab vedotin
排除标准
- •History of another primary malignancy that has not been in remission for at least 3 years
- •Known cerebral/meningeal disease
- •Peripheral neuropathy of grade 2 or greater
- •Females who are pregnant or breastfeeding
研究者
研究点 (31)
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