Consolidation Therapy for Acute Myeloid Leukemia Guided by Leukemia Stem Cell Behavior
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Relapse Free Survival
研究概览
简要总结
The primary objective of the trial is to compare the two-year relapse-free survival (RFS) of patients with acute myeloid leukemia (AML), presumed to be at high risk for relapse due to the presence of leukemia stem cells (LSCs) in their bone marrow at first complete remission (CR1), who receive either standard cytarabine-based chemotherapy or allogeneic stem cell transplantation (SCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years
- •Able to give informed consent
- •New diagnosis of AML, other than APL or poor-risk AML, as defined in section 3.2
- •Exclusion criteria:
- •Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy
- •Any debilitating medical or psychiatric illness that would preclude ability to give informed consent or receive optimal treatment and follow-up
- •Pregnancy: Women of childbearing potential who are β- HCG+
排除标准
- 未提供
研究组 & 干预措施
No Leukemia Stem Cells - Consolidation
Without LSC, standard cytarabine consolidation
干预措施: Cytarabine consolidation (Drug)
Leukemia Stem Cells - Consolidation
LSC present, randomized to cytarabine consolidation
干预措施: Cytarabine consolidation (Drug)
Leukemia Stem Cells - Transplant
LSC present, randomized to allogeneic transplant
干预措施: Allogeneic transplant (Drug)
结局指标
主要结局
Relapse Free Survival
时间窗: 2 years
Percentage of participants alive and without relapsed disease at two years.
次要结局
未报告次要终点