A Phase 2 Study of VL-2397 Compared to Standard First-Line Treatment for Invasive Aspergillosis in Adults With Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, or Allogeneic Hematopoietic Cell Transplant Recipients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Vical
- 入组人数
- 4
- 试验地点
- 56
- 主要终点
- All-cause mortality (ACM)
研究概览
简要总结
The purpose of the trial is to evaluate the safety and efficacy of a new antifungal with a novel mechanism of action in immunocompromised adults with invasive aspergillosis.
详细描述
To compare the safety and efficacy of VL-2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant (allo-HCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The Sponsor, safety monitoring board, and data review committee are masked.
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
- •Acute Leukemia (AML or ALL) patient or allo-HCT recipient with a diagnosis of IA
排除标准
- •Pregnant or breastfeeding
- •IA involving sites other than lungs and sinuses
- •Graft failure, acute or extensive chronic GvHD
- •Uncontrolled diabetes
研究组 & 干预措施
VL-2397
Investigational agent VL-2397 600 mg IV infusion administered every day for 28 days (4 weeks) followed by 2 weeks of standard treatment
干预措施: Investigational Agent: VL-2397 (Drug)
VL-2397
Investigational agent VL-2397 600 mg IV infusion administered every day for 28 days (4 weeks) followed by 2 weeks of standard treatment
干预措施: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B (Drug)
Standard (First-Line) Treatment
Investigator selected standard treatments of voriconazole, isavuconazole, or liposomal amphotericin B administered every day for 42 days (6 weeks) per product package insert
干预措施: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B (Drug)
结局指标
主要结局
All-cause mortality (ACM)
时间窗: 4 weeks
次要结局
- ACM(6 weeks)
- Number of participants with adverse events(6 weeks)