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

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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.