Eltrombopag Used in Thrombocytopenia After Comsolidation Therapy in Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 2 期
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Thrombocytopenia time
研究概览
简要总结
Eltrombopag has been used in the treatment of immune thrombocytopenia (ITP), and significantly increased platelet count and decreased fatal hemorrage. As it's known that all patients with acute leukemia will experience bone marrow suppression and thrombocytopenia after chemotherapy. Some patients even died of fatal bleeding during this period for lacking of platelet transfusion or platelet transfusion refractoriness. So a lot needs to be done to shortern thrombocytopenia time or reduce fatal hemorrage incidence after chemotherapy in acute leukemia patients. In this prospective randomized controlled study, the effect and safety of eltrombopag in the treatment of thrombocytopenia after consolidation therapy in acute myeloid leukemia (AML) is evaluated.
详细描述
Eltrombopag has been used in the treatment of immune thrombocytopenia (ITP), and significantly increased platelet count and decreased fatal hemorrage. As it's known that all patients with acute leukemia will experience bone marrow suppression and thrombocytopenia after chemotherapy. Some patients even died of fatal bleeding during this period for lacking of platelet transfusion or platelet transfusion refractoriness. So a lot needs to be done to shortern thrombocytopenia time or reduce fatal hemorrage incidence after chemotherapy in acute leukemia patients. In this prospective randomized controlled study, the effect and safety of eltrombopag in the treatment of thrombocytopenia after consolidation therapy in acute myeloid leukemia (AML) is evaluated.
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 (Participant)
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with the age range from 14 to 60 years old with AML exclusive of APL in CR status; All those accepting IA or DA (IDA 10mg or DNR 45mg/m2, d1-3, Ara-C 2g/m2 q12h, d1-3) or MDAC (Ara-C 2g/m2 q12h, d1-3) as consolidation regimens.
排除标准
- •Those without obtaining CR; Those experience more 6 cycles of chemotherapy; Any abnormality in a vital sign (e.g., organ function failure, serious infection ); Patients with any conditions not suitable for the trial (investigators' decision).
研究组 & 干预措施
Eltrombopag treatment
Eltrombopag 25mg bid, starts from the day when platelet count decreases lower than 30×10'9/L, and the treatment lasts for at least 5 days, and stops until platelet count goes up to more than 30×10'9/L, after consolidation therapy in AML patents. Platelet transfusion application is routinely done when platelet count is lower than 20×10'9/L or active hemorrage happens to patients.
干预措施: Eltrombopag (Drug)
Eltrombopag free
Eltrombopag treatment is not performed in this group. Platelet transfusion application is routinely done when platelet count is lower than 20×10'9/L or active hemorrage happens to patients.
干预措施: Eltrombopag (Drug)
结局指标
主要结局
Thrombocytopenia time
时间窗: 30 days after consolidation therapy.
The lasting time for platelet count lower than 20×10'9/L after consolidation therapy.
The incidence of fatal hemorrage
时间窗: 30 days after consolidation therapy.
Fatal hemorrage includes all bleedings have life-threaten to the patients, eg. gastrointestinal bleeding, brain bleeding, pneumorrhagia, etc.
次要结局
- The incidence of thrombus(30 days after consolidation therapy.)
研究者
Dan Xu
professor
Nanfang Hospital, Southern Medical University