Phase II Study of Caspofungin Based Combined Anti-fungal Therapy for Patients With Proven or Probable Invasive Fungal Infection After Allogeneic Stem Cell Transplantation From HLA-matched Unrelated or HLA-mismatched Related Donors
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Favorable response rate
研究概览
简要总结
In this prospective phase II observational study, we plan to assess the efficacy and tolerability of caspofungin based combined anti-fungal therapy for proven or probable IFI in a group of patients received allo-HSCT transplantation with high risk of IFI: HLA matched unrelated donor or mismatched donor conditioning with ATG containing regimen or present III-IV aGVHD or extensive GVHD undergoing high-dose steroid treatment.
详细描述
Patients will recieve caspofungin with either voriconazole or amphotericin B as combination therapy for fungal infection
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patient undergoing allogeneic hematopoietic stem cell transplantation
- •age 18-55 years
- •with inform consent
- •no contraindication for allogeneic transplantation: active infection, allergy to FLu/Bu/CTX, liver and renal function damage
- •HLA mismatched related (3~5/6) or unrelated donors (at least 8/10)
- •proven or probable IFI
排除标准
- •age less than 18 years or over 56 years
- •HLA mismatched related donor
- •liver function/renal function damage (over 2 X upper normal range)
- •with mental disease
研究组 & 干预措施
Caspofugin based combination therapy
Caspofugin based combination therapy:
Patients will recieve caspofungin with voriconazole or amphotericin B
干预措施: Caspofugin based combination therapy (Drug)
结局指标
主要结局
Favorable response rate
时间窗: 12 weeks
次要结局
- Overall survival(12 weeks, 1 year)
研究者
Jiong HU
M.D.
Shanghai Jiao Tong University School of Medicine