Evaluation of the Impact of Remission Induction Chemotherapy Prior to Allogeneic Stem Cell Transplantation in Relapsed and Poor-response Patients With AML
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 281
- 试验地点
- 18
- 主要终点
- Disease-free survival
研究概览
简要总结
This trial compares outcome of two treatment strategies for patients with high-risk AML who failed to achieve or maintain a complete remission with standard therapy. Patients will be randomized between two strategies. The standard strategy is aimed at achieving a complete remission by aggressive salvage chemotherapy using high dose cytarabine and mitoxantrone, . The alternative is a less toxic disease-control strategy of disease monitoring and, if necessary, low-dose cytarabine or mitoxantrone prior to allogeneic transplantation, which should be performed as soon as possible.
详细描述
Patients with high-risk acute myeloid leukemia (AML) who relapsed or showed a poor response to induction chemotherapy have a dismal prognosis. For these patients, allogeneic transplantation is the recommended treatment. While allogeneic transplantation may be considered as the ultimate treatment concept, the treatment path to transplantation is not well defined.
The traditional approach to pursue a complete remission by means of aggressive reinduction chemotherapy prior to allogeneic transplantation. This approach is associated with potentially life-threatening toxicities and has limited efficacy. As a result, only some patients will reach allogeneic transplantation in complete remission.
To reduce the number of patients who die or who are ineligible for transplantation due to the toxicity of aggressive induction chemotherapy, other bridging options have been explored. One promising alternative is to abstain from remission induction. Instead, disease control by means of less aggressive chemotherapy or simply monitoring leukemic proliferation can be considered.
This randomized trial will identify if there is non-inferiority of the less toxic approach, compared to the standard approach of remission induction by aggressive chemotherapy prior to allogeneic transplantation.
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
- 18 Years 至 75 Years（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
RIST(remission induction)
high-dose cytarabine 3 g/m2 (days 1-3)/mitoxantrone 10mg/m2 (days 3-5)
干预措施: HAM (Drug)
DISC (disease control)
low-dose cytarabine 20 mg/ m2 and /or mitoxantrone 10mg/m2
干预措施: LDAC and/or Mitoxantrone (Drug)
结局指标
主要结局
Disease-free survival
时间窗: on day 56 after allogeneic SCT
Disease-free survival
次要结局
- Overall survival(4 weeks, 8 weeks, and 24 weeks from randomization)
- Rate of allogeneic transplantation(4 weeks, 8 weeks, and 16 weeks from randomization)
- Incidence of CR(at 4 weeks, 8 weeks, and 24 weeks from randomization)