Effect of Granulocyte-macrophage Stimulating Factor on Prevention and Treatment of Invasive Fungal Diseases in the Recipients of Allogeneic Stem Cell Transplantation: A Prospective Multicenter Randomized Phase 4 Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 5
- 主要终点
- Incidences of Invasive Fungal Diseases (IFD)
研究概览
简要总结
We conducted a prospective, multicenter, open-label randomized trial to compare the antifungal effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF), Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) or a combination of rhGM-CSF and rhG-CSF for neutropenic patients undergoing allogeneic stem cell transplantation.
详细描述
From Sept 2009 to Dec 2012, we recruited consecutive patients with hematological diseases undergoing allogeneic stem cell transplantation at 5 institutions in China. Recipients between ages of 14 to 60 years old were eligible. Eligible patients were randomized to receive once daily subcutaneous 5-7μg/kg/d GM-CSF (Molgramostim, TOPLEUCON®; Xiamen Amoytop Biotech Co., Ltd., China) (GM-CSF group), 5-7μg/kg/d G-CSF (G-CSF group), or a combination of 2-3μg/kg/d GM-CSF and 2-3μg/kg/d G-CSF each (G-CSF+GM-CSF group). Administration of CSFs was started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days). If absolute neutrophil count (ANC) decreased to < 1.5×10(9)/L within 5 days after withdrawal of CSFs, the same CSF would be resumed until the absolute neutrophil count (ANC) reached 1.5×10(9)/L again. All patients received antimicrobial prophylaxis with oral levofloxacin 500 mg daily and antifungal prophylaxis with oral fluconazole 200 mg daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14~60 years old
- •Allogenic hematological stem cell transplantation(HSCT) patients.
- •Cardiac ejection factor ≥ normal upper limit, Aspartate aminotransferase and/or Alanine aminotransferase < 2 upper limit of normal, and/or total bilirubin < 2.5 upper limit of normal, creatinine < upper limit of normal.
- •Informed consent.
排除标准
- •Evidence of proven, probable or possible fungal infection at the time of enrollment.
- •Patients were receiving anti-fungal treatment with proven SFI before transplantation.
- •A history of hypersensitivity to G-CSF or GM-CSF.
研究组 & 干预措施
rhGM-CSF group
subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) once daily
干预措施: rhGM-CSF group (Drug)
rhG-CSF+rhGM-CSF group
a combination of 2-3μg/kg/d Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) and 2-3μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) each
干预措施: rhG-CSF+rhGM-CSF group (Drug)
rhG-CSF group
subcutaneous 5-7μg/kg/d Recombinant Human Granulocyte Stimulating Factor (rhG-CSF) once daily
干预措施: rhG-CSF group (Drug)
结局指标
主要结局
Incidences of Invasive Fungal Diseases (IFD)
时间窗: 100 day post transplant
The incidence of proven and probable Invasive fungal diseases (IFD) within 100 days post transplantation
次要结局
- Hemorrhage Related Mortality(3-1099 days)
- Hematological Engraftment(100 days post transplant)
- Incidence of Ⅱ- Ⅳ Acute Graft Versus Host Disease (aGVHD)(100 days post transplant)
- IFD Related Mortality(3-1099 days)
- Transplant Related Mortality(100 days post transplant)
- Infection Related Mortality(3～1099 days))
- Relapse Related Mortality(3～1099 days)
- Graft Versus Host Disease (aGVHD) Related Mortality(3-1099 days)