Evaluation of allogeneic cell transplantation in acute myeloid leukemia I (ETAL I)

异基因干细胞移植在急性髓系白血病患者中的作用仍然存在争议。虽然大多数研究人员都同意异基因SCT在高危AML患者中介导的生存益处，但到目前为止还没有专门针对标准风险患者的这一问题进行前瞻性随机试验，标准风险由核型定义。由于人类白细胞抗原匹配的无关供者的可获得性增加了具有潜在合适供者的患者的数量，现在第一次有可能将具有潜在供者的患者随机分为两组，一组是首次完全缓解的选择性异基因干细胞移植，另一组是仅在复发情况下的移植。因此，本试验将特别有助于明确异基因干细胞移植在首次完全缓解的急性髓系白血病患者中的作用。为此，570名60岁以下的急性髓细胞白血病患者将必须在三年的研究期内进行预登记。可能会为70%的患者确定匹配的兄弟姐妹或无血缘关系的捐赠者，允许考虑399名患者。在随机前约10%的患者(剩余360名患者)和随机后约10名患者退出后，假设350名患者在首次CR时接受异基因SCT与常规治疗相比，以及仅在复发情况下进行移植之间随机进行最终分析。这350个病例将使人们能够检测到在随机化四年后，异基因SCT和传统缓解后治疗之间总存活率的真正差异约为15%(60%对45%)。

The role of allogeneic stem cell transplantation in patients with acute myeloid leukemia is still a matter of debate. Whereas most investigators agree on the survival benefit mediated by allogeneic SCT in high-risk AML patients, no prospective randomized trial has so far been performed specifically addressing this question in standard-risk patients, with standard risk as defined by karyotype. Since the availability of HLA-matched unrelated donors increases the number of patients with a potentially suitable donor, it is now for the first time possible to randomize patients with a prospective donor between an elective allogeneic SCT in first CR versus conventional postremission therapy and transplantation only in case of relapse.The current trial would therefore specifically help to define the role of allogeneic SCT in AML patients in first CR. For this purpose, 570 patients with AML below the age of 60 will have to be pre-registered over a three years study period. A matched sibling or unrelated donor will probably be identified for 70% of all patients, allowing the consideration of 399 patients. After about 10% drop-outs mainly before randomisation (remaining 360 patients) and a drop out of about 10 patients after randomization, it is assumed that 350 patients randomized between allogeneic SCT in first CR versus conventional therapy and transplantation only in case of relapse will be ready for final analyses. The 350 cases would allow the detection of a true difference in the probability of overall survival between allogeneic SCT and conventional postremission therapy of about 15% (60% vs. 45%) four years after randomisation.