Phase II Trial of Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in High Risk AML Patients Who Are Not Eligible for Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Patients With 2-year Relapse Risk
研究概览
简要总结
AML is the most common acute leukemia in adults. Most patients can undergo allogeneic stem cell transplantation as a possible cure; however, many patients are not candidates for allogeneic transplant due to age, overall health, psychosocial factors, and/or lack of available donors. Therefore, these patients are unable to receive the therapeutic benefits of the "graft-versus-leukemia" effect of donor immune cells. The aim of this study is to hopefully break immune tolerance to AML cells to provide better outcomes in patients with non-favorable risk AML.
详细描述
Non-favorable risk AML patients will undergo a preparative regimen of lymphodepletion of Flu/Mel followed by autologous transplantation. Anti-PD-1 therapy of pembrolizumab will begin on Day +1 following stem cell transplantation and will be administered every 3 weeks for a total of 8 doses. According to the literature, the risk of 2-year relapse is estimated to be 60-80% in patients with non-favorable risk AML in CR-1. With this protocol, investigators hypothesize that following lymphodepleting chemotherapy and pembrolizumab, the 2-year relapse risk will decrease to less than or equal to 35%. The one-sided Wald test at 5% significance level will be used to test the hypothesis. The size of 20 patients yields the power of 90.5% assuming that the actual 2-year leukemia-free survival is 60%.
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 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-favorable risk AML
- •In CR-1 or subsequent CR
- •Completed at least one cycle of consolidation chemotherapy
- •Collection of at least 2x106/kg CD34+ cells
- •KPS of 70% or greater
排除标准
- •Received investigational agent within 4 weeks of first dose
- •Prior chemotherapy, radiation therapy within 2 weeks of first dose
- •Hypersensitivity to pembrolizumab or any of its excipients
- •Received prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
研究组 & 干预措施
Lymphodepletion plus Pembrolizumab
Fludarabine & Melphalan followed by autologous stem cell transplantation. Pembrolizumab will begin on Day +1.
干预措施: Fludarabine (Drug)
Lymphodepletion plus Pembrolizumab
Fludarabine & Melphalan followed by autologous stem cell transplantation. Pembrolizumab will begin on Day +1.
干预措施: Melphalan (Drug)
Lymphodepletion plus Pembrolizumab
Fludarabine & Melphalan followed by autologous stem cell transplantation. Pembrolizumab will begin on Day +1.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Number of Patients With 2-year Relapse Risk
时间窗: 2 years
Hypothesis is that following lymphodepleting chemotherapy and pembrolizumab, the 2-year relapse risk will decrease to ≤35%
次要结局
- Assess Safety of Pembrolizumab by Recording the Number of Participants With Treatment-related Adverse Events(6 months)