A Phase II Randomized Placebo-controlled Study to Assess the Impact on Outcome of Eltrombopag Administered to Elderly Patients with Acute Myeloid Leukemia Receiving Induction Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
- 试验地点
- 15
- 主要终点
- Overal survival rate
研究概览
简要总结
Phase II randomized placebo-controlled study to assess the impact on outcome of Eltrombopag administered to elderly patients with Acute Myeloid Leukemia (AML) receiving induction chemotherapy. A phase II multicenter and randomized placebo-controlled study
详细描述
Subjects will be randomized 1:1 to receive Eltrombopag or matching placebo, in double blinded.
To compare overall survival rate at 12 months between the two arms, with or without 200 mg of Eltrombopag daily after induction chemotherapy
Arm A : Eltrombopag 200 mg (100 mg/day for east Asian heritage) once daily from day 11 of induction chemotherapy to AML response evaluation or platelets count > 100 x 10 Giga/L (maximum day 45)
Arm B : Placebo once daily from day 11 of induction chemotherapy to AML response evaluation or platelets count > 100 x 10 Giga/L. (maximum day 45)
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A
55 patients will be randomized in the experimental arm A. If platelets counts < 100 x 10 Giga/L, patients will be treated with Eltrombopag 200 mg/day per os from day 11 of induction chemotherapy to platelets counts > 100 x 10 Giga/L or maximum to day 45. If platelets counts ≥ 100 x 10 Giga/L on day 11, the start of IP will be delayed until platelets < 100 x 10 Giga/L.
Chemotherapy administration would be performed among standard practice:
- Daunorubicin: 60 mg/m² D1 to D3
- Cytarabine: 100 mg/m²/day, in a continuous 24h-IV infusion D1 to D7
- Lomustine (CCNU): 200 mg/m² per os, at D1.
200mg = 4 Tablets of 50 mg will be done more than 2 hours before Daunorubicin and cytarabine administrations, to avoid vomiting secondary to anthracycline administration.
Investigational Product (IP) will be taken at the same time daily on an empty stomach 1 hour before or 2 hours after a meal or preferably no calcium or dairy products.
干预措施: Eltrombopag (Drug)
B
55 patients will be randomized in the comparator arm B and will received: Placebo once daily from day 11 of induction chemotherapy to AML response evaluation or platelets count > 100 x 10 Giga/L (maximum day 45)
Placebo 200mg = 4 Tablets of 50 mg will be done more than 2 hours before Daunorubicin and cytarabine administrations, to avoid vomiting secondary to anthracycline administration.
Chemotherapy administration would be performed among standard practice:
- Daunorubicin: 60 mg/m² D1 to D3
- Cytarabine: 100 mg/m²/day, in a continuous 24h-IV infusion D1 to D7
- Lomustine (CCNU): 200 mg/m² per os, at D1.
干预措施: Placebo (Drug)
结局指标
主要结局
Overal survival rate
时间窗: 12 months after beginning treatment
overall survival rate at month 12 (year 1) between the two arms, with or without 200 mg of Eltrombopag daily after induction chemotherapy.
次要结局
- Leukemia Free Survival at month 12 (one year)(12 months after beginning treatment)
- Long-term survival(2, 3 and 5 years after first treatment administration)
- Response rate (CR and CRi) at day 45(At day 45)
- Time to platelet transfusion independence(platelets count daily from baseline to the end of induction (day 45) and then at day 60, day 90, monthly until year 1 and finally at year 2, year 3 and year 5)
- Percentage of patients with platelets count > 100 Giga/L at day 45(At day 45)