NCT01246752终止3 期
Randomised Trial on Allogeneic Haematopoietic Stem Cell Transplantation in Patients Under the Age of 60 Years With Acute Myeloid Leukemia of Intermediate Risk in First Complete Remission and a Matched Sibling or Unrelated Donor (ETAL-1)
University Hospital Carl Gustav Carus19 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2011年2月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 143
- 试验地点
- 19
- 主要终点
- Percent of Patients alive after 4 years (Overall Survival)
研究概览
简要总结
Hematopoietic stem cell transplantation in patients with newly diagnosed AML ≤60 years of age in intermediate risk, after first complete response in comparison to standard consolidation chemotherapy
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AML in first remission
- •cytological standard risk, i.e. karyotype not listed under exclusion criteria
- •Identification of HLA-identical sibling or HLA-compatible related or unrelated donor (9/10 HLA-alleles matched, high resolution typing for HLA-A, B, Cw, DRB1 and DQB1)
- •age: 18 - 60 years
- •medically fit for allogeneic stem cell transplantation
- •CR / CRi after induction therapy
排除标准
- •core-binding factor leukemia (t(8;21), inv16)
- •acute promyelocytic leukemia (t(15;17)
- •complex aberrant karyotype
- •karyotypes: -7; -5; del5q; t(3;3); t(6;11), t(6;9), 11q aberrations, trisomy 8 ± one single additional aberration
- •pregnancy / nursing
- •non-compliance
研究组 & 干预措施
Human Stem Cell Transplantation
Experimental
Patients receive an allogenic stem cell transplantation from an HLA-matched unrelated or related donor
干预措施: Human Stem Cell Transplantation (Biological)
Consolidating Chemotherapy
Active Comparator
Patients receive a standard chemotherapy as consolidation therapy
干预措施: Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC) (Drug)
结局指标
主要结局
Percent of Patients alive after 4 years (Overall Survival)
时间窗: 4 years
The status of each patient alive/not alive is surveyed every 3 months in year 1+2 and every 6 months in year 3+4 after randomisation.
次要结局
- Cumulative incidence of non-relapse mortality(4 years)
- Quality of life assessed by questionnaires(4 years)
- Disease-free survival(4 years)
- Cumulative incidence of relapse(4 years)
研究者
研究点 (19)
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