Consolidation Therapy With Brentuximab Vedotin After Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- 1-year Cumulative incidence of relapse (CIR)
研究概览
简要总结
The aim of the trial is to improve disease control after an allogeneic stem cell transplantation (alloSCT) for relapsed or refractory classical Hodgkin lymphoma (rrHL, cHL) with consolidation therapy by Brentuximab Vedotin (BV) for up to one year.
The primary objective of the trial is to show efficacy of the experimental consolidative treatment strategy. Secondary objectives are to further evaluate efficacy, show safety and feasibility and perform correlative studies.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with relapsed/refractory cHL who receive an allogeneic stem cell transplantation
- •Histologically proven cHL in the most recent tumor biopsy
- •Absolute neutrophil count ≥ 500/mm³
- •Age ≥ 18 years
排除标准
- •Presence of nodular lymphocyte-predominant HL (NLPHL) or grey-zone lymphoma
- •Progressive disease as last documented response prior to alloSCT
- •Any peripheral neuropathy ≥ grade 2
- •Any other serious disease or organ dysfunction which might impair protocol treatment
研究组 & 干预措施
Maintenance
Brentuximab Vedotin will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions
干预措施: Brentuximab Vedotin (Drug)
结局指标
主要结局
1-year Cumulative incidence of relapse (CIR)
时间窗: 1 year
1-year Cumulative incidence of relapse (CIR)
次要结局
- 1- and 2-year Progression-free survival (PFS)(1 and 2 years)
研究者
Christoph Scheid
Head of Stem Cell Transplantation
University of Cologne