Pharmacoscopy-guided Clinical Standard-of-care in Relapsed/Refractory Acute Myeloid Leukemia, a Randomized Phase-2 Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Complete response (CR) rate at day 28
研究概览
简要总结
With an overall survival of below 12 months, the outcome of relapsed/refractory AML (RR AML) is poor, making it a critical challenge to identify effective therapies at this stage. The RAPID-01 trial aims to show for the first time in a randomized and controlled clinical trial that Pharmacoscopy (PCY), a functional precision medicine platform, helps improve clinical standard-of-care treatment selection for patients suffering from relapsed/refractory AML.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intervention arm: Pharmacoscopy-guided clinical standard-of-care
Patients in the PCY-guided treatment arm will receive one of the clinical standard-of-care treatments suggested by their own PCY results, and confirmed by the treating physician.
干预措施: Pharmacoscopy (Diagnostic Test)
Control arm
Patients in the control arm will be treated with clinical standard-of-care therapy for RR AML selected by the physician (physician's choice).
干预措施: Clinical standard-of-care (physician's choice) (Drug)
结局指标
主要结局
Complete response (CR) rate at day 28
时间窗: day 28
次要结局
- Composite response rate (CR+CRh+CRi) at day 28(day 28)
- Rate of patients bridged to allogeneic hematopoietic stem cell transplantation within 3 months post-treatment initiation(3 months)
- Treatment-related mortality within 3 months post-treatment initiation(3 months)