A Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic Anemia
试验速览
- 阶段
- 3 期
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Hematologic response (complete response (CR) or partial response (PR)) in patients with immunosuppressive therapy (IST) on day 180 after the start of IST.
研究概览
简要总结
The objective of this study is to evaluate the feasibility and effectiveness of immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline, Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia (SAA) as a primary therapy. The primary endpoint is the response rate (complete response (CR) + partial response (PR)) at day 180 after the start of IST. Secondary endpoints include evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST, relapse rate and overall survival.
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
- None
入排标准
- 年龄范围
- — 至 69 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acquired aplastic anemia
- •Age: younger than 70 years old
- •Severity: SAA, VSAA.
- •Interval between diagnosis and registration <6 months.
- •Written informed consent from the caretakers and/or whenever possible consent from the patient.
排除标准
- 未提供
研究组 & 干预措施
2.5 mg/kg/day of Thymoglobulin for 5 days
2.5 mg/kg/day of Thymoglobulin for 5 days
干预措施: Thymoglobulin (Drug)
3.5 mg/kg/day of Thymoglobulin for 5 days
3.5 mg/kg/day of Thymoglobulin for 5 days
干预措施: Thymoglobulin (Drug)
结局指标
主要结局
Hematologic response (complete response (CR) or partial response (PR)) in patients with immunosuppressive therapy (IST) on day 180 after the start of IST.
时间窗: day 180 after the start of IST
次要结局
未报告次要终点
研究者
Hideki Muramatsu
Assistant Professor
Nagoya University