EUCTR2012-002012-46-IT进行中（未招募）不适用
A pilot phase II study to assess the efficacy of Brentuximab Vedotin administered sequentally with ABVD chemotherapy in patients with untreated Hodgkin Lymphoma
AZIENDA OSPEDALIERA POLICLINICO DI MODENA0 个研究点开始时间: 2012年6月21日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Men or women aged 18-70 years at time of study entry • Previously untreated patients with histologically confirmed CD30+ Hodgkin Lymphoma according to the World Health Organisation (WHO) classification • Stage IA, IIA, IIIA • Absence of bulky disease defined by nodal masses greater than 10 cm in their transverse diameter as a node or nodal mass of 10 cm or greater or a mediastinal mass greater than one-third of the internal transverse diameter of the thorax at the level of T5/T6 (Cotswolds Meeting) • ECOG performance status of 0-1 • Life expectancy > 6 months. • Informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 12
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Peripheral neuropathy > Grade 1 • Histologic diagnosis different from Hodgkin Lymphoma • Compressive symptoms caused by the presence of Lymphoma • Patients who have been treated previously with any anti-CD30 antibody • Known hypersensitivity to any recombinant proteins, murine proteins, or excipients contained in the Brentuximab Vedotin formulation • Known human immunodeficiency virus (HIV) positive • Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection • Patients with congestive heart failure, Class III or IV, by the NYHA criteria • Patients with known active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of Brentuximab Vedotin • Patients with signs or symptoms of progressive multifocal leukoencephalopathy (PML) • Patients with known cerebral/meningeal disease. • Patients who are pregnant or lactating and breastfeeding.
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