A Multicenter Pilot Study of Reduced Intensity Conditioning and Allogeneic Stem Cell Transplantation Followed by Targeted Immunotherapy in Children, Adolescents and Young Adults With Poor Risk CD30+ Hodgkin Lymphoma (HL)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
Patients with relapsed or refractory Hodgkin Lymphoma who are CD30+ will receive a standard of care reduced intensity regimen and an allogeneic stem cell transplant (from another person, related or unrelated). Following recovery, patients will receive a medication called Brentuximab Vendotin which is targeted against CD30+ cells. The study hypothesis is that this treatment will be safe and well tolerated in children and young adults.
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
- — 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •45 years of age or less.
- •Patients with Hodgkin Lymphoma with either of the following:
- •Primary induction failure (failure to achieve initial CR) and/or primary refractory disease OR First, Second or Third relapse AND History of prior ablative auto HSCT or ineligible for an ablative auto HSCT or ≥25% residual disease after at least two reinduction chemotherapy cycles AND HLA matched family donor (6/6 or 5/6) or matched unrelated adult donor (MUD) (8/8) or matched umbilical cord blood unit (≥5/6) with prethaw cell dose of at least 3 x 107/kg TNC.
- •off other investigational therapy for one month prior to entry in this study.
- •adequate organ function
排除标准
- •Patients with HD with 4th or greater CR, PR, and/or SD are ineligible.
- •Patients with rapidly progressive disease (PD) unresponsive to reinduction chemo, radio, or immunotherapy are ineligible.
- •Patients who don't have an eligible donor are ineligible.
- •Women who are pregnant are ineligible.
研究组 & 干预措施
Allogeneic Transplant and Immunotherapy
We intend to utilize reduced intensity conditioning and allogeneic stem cell transplant from HLA matched sibling or unrelated adult donor followed by post-AlloSCT Brentuximab Vedotin in patients with poor risk Hodgkin Lymphoma.
干预措施: Brentuximab Vedotin (Drug)
Allogeneic Transplant and Immunotherapy
We intend to utilize reduced intensity conditioning and allogeneic stem cell transplant from HLA matched sibling or unrelated adult donor followed by post-AlloSCT Brentuximab Vedotin in patients with poor risk Hodgkin Lymphoma.
干预措施: Allogeneic Stem Cell Transplantation (Procedure)
Allogeneic Transplant and Immunotherapy
We intend to utilize reduced intensity conditioning and allogeneic stem cell transplant from HLA matched sibling or unrelated adult donor followed by post-AlloSCT Brentuximab Vedotin in patients with poor risk Hodgkin Lymphoma.
干预措施: Reduced Intensity Conditioning (Drug)
结局指标
主要结局
Overall Survival
时间窗: 1 year
patients will be assessed for one year to determine survival status
Safety
时间窗: 1 year
Patients will be followed for one year for adverse events related to the administration of study drug.
次要结局
- To assess feasibility of developing a bank of LMP-specific CTLs from healthy donors(3 years)